SERACH RESULTS FOR" Development "
development capabilities and future performance in novel drug development, with improved autonomy and agility in business operations. Meanwhile, Samsung Biologics will continue to deliver quality-driven biomanufacturing services, with existing firewalls between Samsung Bioepis, and expand its biopharmaceutical business in its three core drivers: continued capacity enhancement, establishment of growth opportunities in new business areas, such as mRNA and cell and gene therapies, and global expansion. Samsung Biologics is currently building Plant 4, which will break its own record of holding the world’s largest biomanufacturing capacity, and will begin construction this year of a new facility, Plant 5, which will offer multi-modal product services. In addition, the company is in the process of securing additional land of 350,000m2 for Bio Campus II, which will be 30% larger than the size of the current site. Through these milestones, Samsung Biologics continues to deliver on its commitment to its clients and shareholders as a top-tier biopharmaceutical company, while advancing the industry with unparalleled innovation, quality, and client satisfaction.
development and manufacturing
organization, today announced strong financial results for the fourth quarter and
record-high earnings for the fiscal year of 2021.
John Rim, CEO of Samsung Biologics, stated, “With a steep
increase in demand for medicines due to the prolonged COVID-19 pandemic, there
was a great need for CDMO capabilities around the world to ensure a reliable
supply of high-quality biological products. By successfully managing all
potential impact from the pandemic with strong business continuity and
operational excellence, Samsung Biologics achieved solid growth and increased
sales in an extraordinary year and made meaningful progress in building
momentum around our long-term business and capacity. Our fourth-quarter
financial performance demonstrates our ability to execute a robust and
resilient approach to maintaining business continuity while adapting at every
level to the needs of our clients and partners. Our concerted efforts have
enabled us to achieve our financial targets and lay a foundation to deliver
future growth. As we look towards 2022, we remain fully committed to delivering
high-quality, life-saving treatments to our partners and patients around the
FOURTH QUARTER &
FISCAL YEAR 2021 RESULTS
Fourth quarter 2021 revenue was KRW 444.3 billion, an
increase of 18% from KRW 375.3 billion reported for the fourth quarter in the
previous year, attributable to increased utilization of Plants 1 and 3, and
sales activities bringing in new contracts.
Fourth quarter 2021 operating profit was KRW 128.8 billion,
39% higher than the prior-year period leveraging steady sales growth.
Fourth quarter 2021 net profit reached KRW 79.3 billion, a
decrease of KRW 16.9 billion from KRW 96.2 billion in the fourth quarter a year
ago, and fourth quarter 2021 operating margin was 29% due to increased
utilization across all plants and improved product mix.
Samsung Biologics demonstrated strong operational
excellence and business agility in 2021 with Plants 1, 2, and 3 in stable
operations, and laid a strong mRNA business foundation through signing strategic
partnership agreements with Moderna for fill and finish and Greenlight
Biosciences for the manufacturing of mRNA vaccines. Samsung Biologics also
launched its newest CDO process platform, S-CellerateTM, which
offers an expedited process for the development and commercialization of monoclonal
FISCAL YEAR 2022
development and commercialization of monoclonal antibodies. In light of the increasing importance of actions towards sustainability, Samsung Biologics issued its first annual sustainability report, consolidating the company’s policies for an enhanced ESG management system. The company was recently added to the DOW Jones Sustainability World Index (DJSI) in recognition of its commitment to ESG matters. “The strategic roadmap and milestones outlined today illustrate the key success drivers for our growth this year as well as lay a strong groundwork for sustainable growth opportunities ahead of us,” Rim added. “With our continued investment in capacity, portfolio, and global footprint, we will evolve as the top biopharmaceutical company and offer diversified services as the next growth engine of the industry.” About Samsung Biologics Co., Ltd.Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit samsungbiologics.com.
development services to support our clients’ current needs, but also their long-term supply chain strategy as well. With the demand in biopharmaceutical services consistently rising, Jinyong is driven to help clients achieve our shared goal of providing high-quality medicines to patients faster than anyone. That’s where Plant 4 comes in. As a one-stop shop allowing significant savings in cost and time for our clients, Plant 4 is expected to be the world’s largest biomanufacturing facility of its kind, boasting 256,000 liters of total manufacturing capacity, and will provide process flexibility for clients to scale up or down during the full lifecycle of their products. Upon its completion, Samsung Biologics is estimated to be accountable for approximately one-fourth of the total global mAb CDMO manufacturing capacity, offering a combined sum of 620,000 liters from a single site. Hear Jinyong discuss how by building our innovative, multi-scale Plant 4, we’ll be meeting the growing market demand and rapidly evolving expectations of our clients as well as what makes Samsung Biologics culture so special. What are your job responsibilities at Samsung Biologics?I oversee business relationships with 80+ global clients. Our group’s goal is, largely speaking, two-fold: existing client relationship management and business expansion. All our projects need constant care…so we provide extra hands to make sure the projects are there to meet our clients’ needs, and through that entire process, we want to earn their trust. Plant 4 is Samsung Biologics’ most ambitious project to date. Can you briefly explain why that is?It’s truly a mega-project. We’re investing over $1.5 billion into it, and it will be the single biggest plant in the world. With a total capacity of 256,000 liters, it comes with 12 15KL bioreactors, six 10KL, and eight 2KL. Putting all the pieces together means we’ll be providing a wide variety of flexibility in terms of scale to our clients. It really symbolizes the rapid growth of Samsung Biologics from where we were in the past 10 years, where we are now, and where we’re heading in the future. Can you give insight behind our decision to expand to this large of scale?The biologics drug industry is evolving at an unprecedented pace. Biologics bring much more value to patients compared to traditional medicines from an efficacy standpoint, which is why not only has the demand gone up, but also the manufacturing and accessibility challenges that come along with it. I believe Samsung Biologics is uniquely well positioned to solve, and close the gap from that perspective. Our state-of-the art EPCV capabilities, combined with a quality-driven operational excellence, will really help our pharma clients bring the drugs to the market in an effective and efficient way. What are some of the plant’s unique features and how will we leverage it for new and existing projects once it’s up and running?First and foremost, flexibility is integral. As I mentioned before, Plant 4 comes with a variety of scales – 15K, 10K, and 2K. Market demand is really unpredictable in nature so this will help our clients to be able to adjust in terms of the market trends. The other feature I want to highlight is quality. Plant 4 will operate under the same philosophy and quality protocol [that we use in our existing plants]. It will obviously help us to maintain the highest industry standard for the quality of the product that we’re making across all the plants. Finally, in order to keep up with the market trends, we’ve been preparing [for Plant 4] to have a high degree of digitalization and sustainability. With the combination of everything, we are confident that Plant 4 will satisfy not only our existing clients but future potential clients as well. Where are we currently in the construction process and when do we expect it to be operational?Plant 4 construction is progressing on schedule, and many of our clients are already asking for operations to com
development and manufacturing services. This marketing authorization obtained by Moderna Korea officially allows the Moderna’s COVID-19 vaccine manufactured at Samsung Biologics’ local pharmaceutical production facilities to be distributed within Korea and exported to other countries.In May 2021, Moderna and Samsung Biologics announced the agreement for fill-finish manufacturing of the Moderna COVID-19 vaccine. Upon execution of the deal, Samsung Biologics successfully reduced the overall timeline by leveraging its technology and capabilities, enabling the first batch of Moderna’s COVID-19 vaccine to be released for domestic supply within five months from the signing of the contract. Moderna Korea applied for a full marketing authorization for Spikevax® with the MFDS in early November, and successfully obtained it within a month’s time.The Philippines and Colombia authorized emergency use of the Moderna COVID-19 vaccine manufactured by Samsung Biologics on November 26 and December 2, respectively. “We thank the Ministry of Food and Drug Safety of Korea for their decision to approve this marketing authorization. Our partnership with Samsung Biologics for fill-and-finish manufacturing of the Moderna COVID-19 vaccine is helping us continue to scale up our manufacturing capacity outside of the U.S.,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Along with our manufacturing partners, we remain committed to defeating the COVID-19 pandemic.” “This is truly a significant milestone as we were able to accelerate the approval process in close and prompt collaboration with the Korean government and Moderna, especially under the MFDS’s rigorous screening for the first fill-finish manufacturing of mRNA vaccines in Korea,” said John Rim, CEO of Samsung Biologics. “We were also proud to demonstrate our commitment to providing both quality and agility throughout our processes, and will continue to work closely with our client to stably supply the products especially in light of the increasing importance and demand for vaccines in the battle against the COVID-19 pandemic.”Moderna has multiple strategic partners for fill-finish manufacturing. In the U.S., this includes Catalent, Inc. (NYSE: CTLT), Baxter BioPharma Solutions and Sanofi (Nasdaq: SNY). Outside of the U.S., this includes Rovi (BME: ROVI) in Spain, Recipharm in France and Samsung Biologics (KRX: 207940.KS) in Korea.
development and manufacturing organization, continues its strategic biopharmaceutical manufacturing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN). The partnership is based on an expanded deal this year in May 2021 which followed the signing of a long-term strategic agreement made in September 2020. Under the agreement, valued at approximately $380 million up from the initial $331 million for the production of drug substance and drug product, Samsung Biologics manufactures AstraZeneca’s COVID-19 long-acting antibody (LAAB) combination, AZD7442, and will start to manufacture a cancer immunotherapy product from next year.AZD7442 is a combination of two LAABs being developed for the prevention and treatment of COVID-19. AZD7442 is the first LAAB to receive an EUA from the US Food and Drug Administration (FDA) for COVID-19 prevention and it has received authorizations from the US, France, Italy, and Bahrain.AZD7442 has the potential to complement national vaccination programs by providing additional protection for those considered at increased risk of an inadequate response to a COVID-19 vaccine, including people who are immunocompromised, patients on dialysis, oncology patients, those taking medications after an organ transplant or those who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.Pam Cheng, Executive Vice President, Global Operations and IT, AstraZeneca said, “Over the past year Samsung Biologics has been a highly capable and collaborative partner on our novel COVID-19 long-acting antibody combination. We are excited about expanding our work together into cancer immunotherapy and about laying the foundation for continued growth of our collaboration in the years ahead.” “We are delighted to continue expanding our strategic collaboration with AstraZeneca, a valuable partner we have witnessed first-hand to have a strong commitment to saving lives of patients,” said John Rim, CEO of Samsung Biologics. “We will support our clients by bringing innovative solutions to an array of diseases, especially during this time when it is needed the most, and together find ways to expedite the delivery of crucial therapies to the market.”Samsung Biologics has been proactive in accommodating the varying needs of clients including the building of an additional facility, Plant 4, upon completion of which will allow the company to hold the world’s largest biomanufacturing capacity of 620,000L, and the addition of a messenger RNA vaccine drug substance (DS) manufacturing suite to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022.
development and manufacturing organization, held an award ceremony with the British Standard Institution at its Songdo headquarters for global ISO9001 certification in recognition of the company’s Quality Management System. The attainment of this certificate reaffirms Samsung Biologics’ capabilities to ensure high-quality service offerings across all value chains for a product life cycle, further enhancing its operational excellence for clients and ultimately offer improved patient outcomes. “Achieving an ISO 9001 certification is a critical milestone in our journey to building a quality driven organization in everything we do. Our services and products improves the healthcare of nations and, literally, saves lives. Our commitments to our customers and to the patients they serve are a foundation for every employee at Samsung Biologics. This certification is an additional testament that we will always look for ways to improve our quality systems to support our business and its purpose the best we can” Sam Machour, Senior Vice President & Chief Quality Officer of Samsung Biologics, said in a statement. By meeting the comprehensive set of requirements for the global certification, Samsung Biologics demonstrated its Quality Management System to be in full conformance to ISO 9001:2015 requirements in addition to cGMP regulations across all of the company’s CMO (Drug Substance/Drug Product/small-scale Drug Substance) and CDO business units in its entire facilities. With the certification, the company is expected to further offer quality-oriented processes across all functions within the organization. “We are extremely proud to be adding another global ISO certification to our facility during a time where a high-degree of quality management system is vital to safely supply biomedicines to patients,” said John Rim, CEO of Samsung Biologics. “Through this certification, we will be able to further operate under an optimized and compliant management system in which we can build a more sustainable value chain for our stakeholders, clients, and partners, and ensure a stable supply of highest quality products.” Recently in August this year, Samsung Biologics obtained four global ISO certifications: ISO22301 (Business Continuity Management), ISO50001 (Energy Management), ISO45001 (Occupational Health and Safety Management), and ISO14001 (Effective Environmental Management) to its facility, further advancing both its internal and external capabilities to stably operate and withstand any market fluctuations while maximizing client satisfaction and fulfilling its social responsibilities.
development platform S-CellerateTM which both enable Samsung Biologics’ team to provide more competitive and innovative service offerings to clients, ultimately accelerating the speed of molecules to market whilst ensuring the highest quality of products. In light of the pandemic, the company has also been proactive in accommodating client needs in the biopharma CDMO landscape, including its plans to add messenger RNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022. In the field of digitalization, Samsung Biologics continues to embrace and leverage the latest technology to enhance client experience. We introduced our Virtual Exhibition Hall which through an immersive and interactive experience enabled by photorealistic 3D modeling, visitors are able to view our business services and facilities, and have richer conversations with our team of experts. We also implemented the Live Virtual Tour (LVT) to allow for global clients to access our facilities via a live-streaming platform and take a scheduled tour, audit, or inspection at their convenience. The platform also leverages a global on-demand cloud infrastructure to optimize speed and connectivity for clients and regulatory bodies from any location. Through collaborative efforts and continuous improvements in our facility and service offerings, we will continue to advance forward with ‘Speed’, ‘Quality’, ‘Innovation’ as our core values and help build a better future for humanity. Related Contents Life @ Samsung Biologics It's in our DNA Press Releases GreenLight Biosciences and Samsung Biologics announce collaboration to build capacity for messenger RNA Vaccine Manufacturing Samsung BIO Insight Samsung Biologics at BIO Digital 2021
It’s in our DNA At Samsung Biologics, we continue to demonstrate our operational excellence across all value chains thanks to the unique business DNA our employees share at the company. At our recent branding film we reinforced our shared mission to be ‘Driven. For Life.’ Driven. to take on challenges
To accelerate time to market and meet urgent patient needs, we leverage all available resources in our end-to-end service, while balancing speed and quality. In this whitepaper, Daniel Buckley, our Lead Scientist in CDO Downstream, details how our proprietary technology platform, S-Cellerate™, offers an expedited CDMO timeline to IND. Using S-Cellerate™, clients have been able to reach IND filing in as fast as 9 months as well as access our full spectrum of services - from process characterization and validation to BLA submission - while maintaining the highest product quality and operational robustness.
development and manufacturing. Samsung Biologics is currently in agreement with Moderna to provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine which was announced in May this year. "It's an honor to receive this award and be recognized as a team for our efforts and capabilities to manufacture vaccines in a short time frame," said David King, Director of Drug Product Operations at Samsung Biologics. "Samsung Biologics has grown tremendously within the past decade and I would like to take this opportunity to thank all the teams and also the clients for the generous support they have shown us to successfully manage the manufacturing processes throughout."
development and manufacturing services, announced a partnership agreement in which Samsung Biologics will manufacture GreenLight’s messenger RNA COVID-19 vaccine candidate at commercial scale. The partnership aims to accelerate production of GreenLight’s COVID-19 vaccine candidate for Phase III clinical trials and, subject to regulatory approval, commercial sales. The collaboration with Samsung will leverage GreenLight’s existing manufacturing process, with technology transfer from GreenLight to Samsung starting immediately. Both Samsung Biologics and GreenLight are committed to vaccine equity and envision a world capable of producing enough messenger RNA vaccine doses for billions of people a year. This supports GreenLight’s ambition to help vaccinate the world against COVID-19, as detailed in its Blueprint To Vaccinate The World published in March 2021. This vision aligns with calls by CEPI, and others for concrete actions to increase vaccine manufacturing capacity across the world, not just for COVID-19, but also for other infectious diseases reflecting the ongoing global health needs.“We are delighted to partner with Samsung to manufacture messenger RNA for our Covid vaccine trial. There is an urgent need to develop vaccines for the whole world,” said GreenLight CEO Andrey Zarur. “Our vaccine trial will open the way to make vaccines that are available to everybody, not just citizens of developed countries.”“We are delighted to partner with GreenLight to leverage our expertise in manufacturing a messenger RNA COVID-19 vaccine candidate to better serve patients in lower income countries,” said John Rim, CEO of Samsung Biologics. “This collaboration demonstrates a major milestone for Samsung Biologics as we will commence our expanded capabilities and operations to provide one-stop end-to-end messenger RNA production from Drug Substance (DS) to Aseptic Fill Finish (DP) to commercial release, all from a single site. At this time of urgent global demand, we will strive for seamless service across our biomanufacturing network to fight the COVID pandemic and in turn, help make progress towards Korea's vaccine hub goal.” Samsung Biologics has been proactive in accommodating client needs in the biopharma CDMO landscape, including its plans to add messenger RNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022.
Evaluating and characterising complicated protein structures and the therapeutic activity of advanced biotherapeutic molecules requires sensitive analytical technologies and informatics systems. As such, executing accurate, analytical assessments of complex biological molecules in a commercial laboratory setting can be challenging, explains Eliza Lee, Lead Scientist Analytics, Samsung Biologics. Read More All rights are reserved by the media that published this article.
development & manufacturing services for their drug portfolios. "This was an important event for Samsung Biologics as it was the first large on-site exhibition since the COVID-19 pandemic to engage with global clients in person. We met with a large number of clients from all over the world and were able to demonstrate our services and capabilities, advancing it to in-depth business discussions for future projects," Donghyun Kim, a Lead Specialist on the Sales Team, stated. Haeun Yu, a Senior Specialist on the Sales Team, added, “We introduced some of our recent milestones, such as our ability to offer multi-modalities including mRNA, the launch of our new CDO process platform S-CellerateTM and our own proprietary cell line S-CHOice®, and Plant 4, to-be the world's largest biomanufacturing facility to date. We had visitors tell us that they came to this year's CPhI Worldwide just to meet with us and it was amazing to see the increasing worldwide interest and demand for Samsung Biologics' service offerings." ‘Driven. For Life.'At CPhI Worldwide 2021, Samsung Biologics also introduced its new corporate advertising/branding video as a preview to the visitors, especially featuring its business purpose of ‘Driven. For Life.’ as well as its key attributes of speed, quality, and innovation DNA. - 'It’s in our DNA', 'What are you driven. for?' episodes represent the company's work to save the lives of people around the world.- 'Together, We' series comprises of three episodes - 'Speed', 'Quality', 'Innovation' - which represent the core values that Samsung Biologics stands for. Maximizing client satisfaction and saving patients' livesSamsung Biologics would like to thank everyone who connected with us at this year's CPhI Worldwide, whether you visited the booth or networked at the reception. Orhan Caglayan, Brand Director of Informa Markets, the organizing body of CPhI Worldwide shared his views on this year's event during an interview with Samsung Biologics. “For the past thirty years, CPhI was a setting for industry leaders to discuss the innovation of the biopharmaceutical industry. By far, this year is probably the year where we were all able to witness in person how biologics is now the future of the pharmaceutical industry and Samsung Biologics is at the forefront of this shift.Samsung Biologics has always been our partner and I want to express my sincere gratitude to you for participating in this global event despite the COVID-19 pandemic," Orhan Caglayan said. Samsung Biologics will continue to pursue innovation in every area, while ensuring speed and quality to ultimately create a better future for humanity. Driven. For Life. Related contentsNews Brief Samsung Biologics participates in CPhI Worldwide 2021BIO Insight Talking COVID-19 Vaccine Cooperation with John Rim
development and manufacturing organization (CDMO), today announced record-high financial results for the third quarter of fiscal 2021. John Rim, CEO of Samsung Biologics, stated, “We are pleased to continue with a strong momentum in our third-quarter financial performance posting the highest quarterly results thanks to the stability, quality, and efficiency of our business units in delivering pharmaceutical products to our valued clients, while maintaining a safe environment for our workforce amid the prolonged pandemic. Looking forward, we remain focused and positive on fulfilling our responsibility as a leading company in the global CDMO market. We continue to be excited with the progress we are making on our pipeline expansion in terms of the breadth of service offerings and the introduction of new technologies.” THIRD QUARTER 2021 RESULTS Third quarter 2021 revenue was KRW 450.7 billion, an increase of 64% from KRW 274.6 billion reported for the third quarter in the previous year, attributable to near-full operations at all three of its plants. Third quarter 2021 operating profit was KRW 167.4 billion, 196% higher than the prior-year period leveraging strong top-line growth. Third quarter 2021 net profit reached KRW 131.8 billion, an increase of KRW 75.7 billion from KRW 56.1 billion in the third quarter a year ago, and third quarter 2021 operating margin was at a record-high 37% due to increased utilization across all plants and product mix, including fast-turnaround COVID-19 treatments. [KRW billion] Q3’21 Q3’20 YoY Change Revenues 450.7 274.6 +64.1% Operating Profit 167.4 56.5 +196.3% EBIT 197.3 73.7 +167.7% Net Income 131.8 56.1 +134.9% FISCAL YEAR 2021 OUTLOOK The annual revenue is expected to remain steady with stable operations across all production facilities, and active pre-sales activities are ongoing for Plant 4 despite the challenging business environment amid the COVID-19 pandemic. In addition to recording a strong cumulative backlog of USD 7.1 billion in signed contracts with pharmaceutical companies such as Roche and MSD, Samsung Biologics launched S-CellerateTM, its new drug development service platform which offers an expedited process for the development and commercialization of monoclonal antibodies to IND and BLA. Along with its proprietary cell line development platform S-CHOiceTM, the company’s CDO business continues to bring quality-driven, end-to-end development services to accelerate the speed of molecules to market. Furthering its sustainability efforts, Samsung Biologics joined the global Frontier -1.5D initiative to develop a climate risk management model as part of the 2050 Carbon Neutral Strategy in response to the ongoing challenges associated with global climate change. Through its Carbon Disclosure Project, the company will determine the risks and opportunities within its business to address climate change, and then analyze the financial impact to adjust its response policies in relation to factors such as the reduction of GHG emissions. Despite the lingering effects of the COVID-19 pandemic on global markets, Samsung Biologics has maintained stable business operations and the construction of plant 4 remains on track and active discussions are ta
development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies to IND. · Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center. College Station, TX, U.S. and Incheon, S. Korea, October 07, 2021 – Samsung Biologics (KRX: 207940. K.S.), a leading contract development and manufacturing organization and Enzolytics (ENZC), a drug development company committed to commercializing multiple proprietary therapeutics to treat debilitating infectious diseases, announced the signing of a strategic CDMO partnership agreement. Under the terms of the agreement, Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibodies for the treatment of HIV and SARS-CoV-2. In addition, there will be continuing discussions for other Monoclonal Antibodies being developed by Enzolytics. The Enzolytics protocol offers the opportunity to implement A.I. analysis and provides a platform for creating multiple fully human Monoclonal Antibodies targeting conserved immutable sites on the virus and offering a cure for these viruses. A stable cell line will be manufactured with support from Samsung Biologics' R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea. “Partnering with Enzolytics reinforces the value of our fully integrated, end-to-end business model, which is designed to meet the unique needs and goals of our biotech clients,” said John Rim, CEO of Samsung Biologics. “We look forward to providing comprehensive services and professional support for the manufacturing of this important class of Monoclonal Antibody therapeutics for the treatment of HIV and SARS-CoV-2, helping to accelerate the process of drug development to IND filing and bring these life-saving products to patients.” "The collaboration with Samsung Biologics is a significant milestone for Enzolytics' Artificial Intelligence enabled Monoclonal Antibody Platform. We chose to partner with Samsung Biologics because of Samsung Biologics' extensive experience and expertise in developing, producing, and manufacturing Monoclonal Antibodies for Infectious Diseases and Oncology.” said Dr. Gaurav Chandra, Chief Operating Officer Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."
development solution resulting in accelerated timelines to IND and BLA, ultimately for the development and commercialization of monoclonal antibodies. This platform includes two distinguished services: an accelerated CDO timeline to Investigational New Drug Application (IND), and a complete solution for commercialization to reach Biologics License Applications (BLA). With S-CellerateTM, clients are able to complete IND filing in as fast as 9 months, while being able to access a full spectrum of services from process characterization and validation to BLA submission and ensure the highest product quality and operational robustness.
manufacturing organization (CDMO), introduced its proprietary technology
platform, S-Cellerate™, at the BioProcess International
Conference (BPI 2021) to offer clients an integrated and seamless drug
development solution resulting in accelerated timelines.
development and manufacturing organization, announced the signing of an MOU today to participate in the Frontier 1.5D initiative to develop a climate risk management model as part of 2050 Carbon Neutral Strategy in response to the ongoing challenges associated with global climate change. The Frontier 1.5D project is a global collaborative effort to limit temperature rise to 1.5°C above pre-industrial levels, and local business leaders have joined forces with the British Embassy, Ewha Woman’s University, Financial Supervisory Service, to collectively thrive for a net-zero future. Frontier 1.5D is expected to address uncertainties associated with climate change by analyzing the financial impact of climate change and climate response policies such as GHG reductions. Samsung Biologics, as a business sector representative, will be closely monitoring, identifying, and providing data for each of its biopharmaceutical manufacturing plants through its Carbon Disclosure Project (CDP) initiative with Science Based Targets (SBT) to determine risks and opportunities on climate change as well as the financial impact to translate these data into actions. "We are proud and honored to be a part of the vital Frontier 1.5D initiative to ultimately redefine energy efficiency and reusable energy through the reduction of GHG emissions," said John Rim, CEO of Samsung Biologics. "Alongside our core mission to bring a healthier and sustainable future for humanity, Samsung Biologics will support the development of mid to long-term climate change strategies and action plans as part of our decarbonization efforts to achieve a net-zero future."
development strategy to augment their capacity & expertise and ultimately reduce time to market. And the CDMOs are trying to adapt to new market dynamics where speed and efficiency are critical to long term success. This fireside chat will demonstrate how Samsung Biologics is delivering unique values to the clients and also highlight on critical success factors in the partnership while the industry continues to evolve.
development of biologics to reach product approvals before going into large-scale manufacturing. With considerable challenges to safely and effectively develop biologics, many biopharmaceutical companies are choosing to outsource their development processes to CDO partners. In response to the increasing demand of biologics, Samsung Biologics now not only holds the world’s largest biomanufacturing capacity, but also offers contract development services, establishing the company as a one-stop CDMO service provider. In October 2020, Samsung Biologics opened its first R&D Center in San Francisco, at the heart of the leading U.S. bio-cluster, to be in close proximity to clients as the next door CDO partner. In this article, we will explore the services a CDO partner provides and the unique capabilities Samsung Biologics can bring for a molecule’s success.*Refer to “A New Era in Biotechnology: What are Biomedicines?” Contract Development Services to Expedite Success for Your MoleculeThe development of new drugs is divided into two different stages: the ‘discovery’ stage where a candidate molecule for a specific disease is discovered and the ‘development’ stage which includes all the processes that are required to reach clinical trials and gain product approvals. Contract Development Organizations (CDO) provide the ‘development’ part of the service required for the overall development of new drugs.
development?I believe the Human Resources Team’s role is to foster a learning environment where our employees can continuously learn and grow. Our HR Team provides systematic training opportunities such as new employee training…leadership training, language courses, etc. One special thing about Samsung Biologics is that we do operate a BioTech Academy where new hires get hands-on experience in a small-scale laboratory setting before they enter into large-scale GMP manufacturing facility. We are always fostering employees to become bio experts in the industry. What advice would you give to future interns?I always tell the interns to be more proactive. Come prepared, reach out, ask questions, and learn as much as you can to make your internship experience valuable. But don’t forget to be yourself. What makes Samsung Biologics’ culture unique?I’d like to say that our corporate culture is energetic, passionate, global, and fast-paced. When I come into work every day, I can feel that everyone is showing up not just for the work itself, but to work towards our main goal to help save lives and foster a better community in human health. I feel like we’re working as one team to accomplish this. In terms of global, at Samsung Biologics, we have many global expatriates from 18 different countries including US, France, Switzerland, China, India, etc. We’ve also grown exponentially over the past 10 years. We started as just 10 employees, but now we’ve reached 3,500 and we’re still growing really fast. When you hear the phrase "Driven. For Life.", what comes to your mind?When I see the phrase “Driven. For Life.”, it continuously reminds me that I’m working to save lives and to make our community a better place. I believe this spirit of Samsung Biologics is very important since it’s reminding and motivating our employees to take on new challenges so that we grow every day. Related Contents YouTube A Day in The Life of a Samsung Biologics InternYouTube Samsung Biologics Internship: Most Memorable Experiences
development and manufacturing organization (CDMO), Samsung Biologics is all set to add mRNA vaccine drug substance manufacturing suite to expand its portfolio of services. In conversation with BioSpectrum Asia, James Choi, Senior VP, Chief Information and Marketing Officer, and Head of Investor Relations, Samsung Biologics, South Korea, talks in detail about the company’s growth plans.Read moreAll rights are reserved by the media that published this article.
development and manufacturing organization, today announced strong financial results for the second quarter of fiscal 2021. John Rim, CEO of Samsung Biologics, stated, “The second-quarter financial performance demonstrates our ability to maintain steady operations despite the global supply disruptions brought on by the pandemic and our commitment to deliver life-saving treatments to patients at an expedited timeline. Recently, we announced our expansion plans in mRNA vaccine manufacturing, in line with our three-dimensional growth plans laid out earlier on in the year. Construction and presales of our Plant 4 are on track, and we will take on new initiatives as we continue our strong momentum across our business portfolio and growth plans.” SECOND QUARTER 2021 RESULTS Second quarter 2021 revenue was KRW 412.2 billion, an increase of 34% from KRW 307.7 billion reported for the second quarter in the previous year, attributable to increased utilization of Plant 3 and sales activities bringing in new contracts, including COVID-19 products. Second quarter 2021 operating profit was KRW 166.8 billion, 105.7% higher than the prior-year period leveraging strong top-line growth. Second quarter 2021 net profit reached KRW 121.5 billion, an increase of KRW 69.5 billion from KRW 52 billion in the second quarter a year ago, and second quarter 2021 operating margin was at a record-high 40.5% due to increased utilization across all plants and product mix, including fast-turnaround COVID-19 treatments. [KRW billion] Q2’21 Q2’20 YoY Change Revenues 412.2 307.7 +104.5 Operating Profit 166.8 81.1 +85.7 EBIT 175.0 67.8 +107.2 Net Income 121.5 52.0 +69.5 FISCAL YEAR 2021 OUTLOOK The annual revenue is expected to remain steady at the mid-20% range amid full operations at Plants 1 and 2, and near-full operations at Plant 3. The high utilization rate is also expected to drive an increase in the annual operating profit. The company signed a contract with Moderna in May this year to provide fill-finish manufacturing of its COVID-19 vaccine and announced a plan to add an mRNA vaccine drug substance manufacturing facility to expand its portfolio of services. Plant 4 construction remains on track with active presales discussions, commencing its partial operations by the end of 2022 and expected to be fully GMP-ready in 2023. The San Francisco R&D Center is also fully equipped for high-quality cell line development in support of client pipelines in close proximity to the U.S. market. Samsung Biologics has maintained stable business operations with no disruption caused by the pandemic and is currently able to continue as planned with key strategic growth projects and long-term investments. For more details on performance and financials, please refer to the Earnings Release.
Technology transfer is a critical step along the path to the large-scale production of COVID-19 therapeutics, but its highly complex nature makes it time consuming. In this whitepaper, Andrew Kim, our Associate Director of Downstream MSAT, explains how accelerating tech transfer without sacrificing quality demands strong communication, operational agility, early investment in critical path items, and continuous risk management. As a trusted CDMO partner, Samsung Biologics has successfully accelerated tech transfer down to three to five months for clients developing COVID-19 therapies.
development and manufacturing expertise to advance KVA12.1 to IND- Samsung Biologics San Francisco R&D center and South Korea headquarters to offer a seamless, end-to-end CDMO serviceSamsung Biologics, one of the world’s leading contract development and manufacturing organization (CDMO), signed a strategic partnership agreement with Kineta, Inc., a clinical-stage biotech company developing novel immunotherapies in oncology. Samsung Biologics will provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumors.VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.The manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.“We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market,” said John Rim, CEO of Samsung Biologics. “We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success.”“Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year”, said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. “We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy”.Samsung Biologics offers seamless one-stop CDMO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.
developments in LVT using a customer-centric view. Other than Live Virtual Tour, what other digital enhancements or technologies have you utilized?We are actively preparing and using cloud technology for global expansion. For global companies, this is not an option any more. The cloud’s flexibility, scalability, agility, and cost are all at the heart of digital transformation, which we are continuously innovating to be a leading CDMO provider in the biopharma industry. Can you give us any insights into what IT trends biopharmaceutical companies are talking about now?Artificial Intelligence (AI) is already at the forefront of our lives, it’s not just in the domain of engineers anymore. AI will be a key driver in determining the competitiveness of the industry. We need to pay attention to newer trends and needs of the BIO industry based on AI as well as collecting and analyzing data by looking at other industry examples. Now more than ever, we have a mindset that always starts with data as well as preparation, execution, and creation with data. What makes Samsung Biologics’ culture unique?In our ten years of history, we have overcome any challenge by constantly finding new approaches to create solutions. What makes our culture special is that we have an experienced and skilled workforce who are all really passionate about what we do. For this reason, we are instinctively creating everything at a faster pace and moving forward with confidence and hope. I would say that Samsung Biologics is a very rare and special company that makes these leaps, cultivates, and builds passion within such a short period of time. When you hear the phrase "Driven. For Life.", what comes to mind?The goal and reason for the existence of most companies would be to pursue profitability. While it’s still important, Samsung Biologics’ ultimate mission is to build a healthier future for all. In terms of industry, we are creating the future through the work we do in bringing high-quality biomedicines to our clients and patients around the globe. This in turn gives hope and life to humanity. Related Contents Samsung BIO Insight Samsung Biologics embraces digitalization to provide next-level client satisfactionWebinars Innov-daptation: Shifting Challenges to Opportunity in BioManufacturingWhitepapers Embracing Necessary Digital Transformation in Biomanufacturing
development and commercialization of existing products is done reliably. Outsourcing also allows companies to save heavily on investment costs to expand their own development and manufacturing facilities. Biopharmaceuticals: The Journey for Successful Manufacturing Single of CMO Contract Tech Transfer Engineering Run Process Validation Run Application for Approval from Regulatory Agency CMOs provide manufacturing services to their clients on a contract basis to supply quality products, on time at a competitive price. Upon signing a CMO contract with a client, a complex journey begins to ensure successful manufacturing of biopharmaceuticals. A process called ‘Tech Transfer’ is required to manufacture a molecule that is developed by the client. This involves the transfer of technologies including the manufacturing processes, analysis methods, and testing methods into the CMO partner’s facility. Afterwards, processes called the ‘Engineering Run’ and ‘Process Validation Run’ are conducted to optimize the variables during the manufacturing process, the pilot-scale manufacturing is completed and product’s stability is verified throughout every stage of the process. Only after completing the in-house manufacturing preparation processes can a CMO apply for manufacturing approval of production goods and processes for certification to international regulatory agencies, such as the FDA and the EMA. Once the processes have been approved, large-scale manufacturing can begin. CELL LINE INOCULUM SEED BIOREACTOR PRODUCTION BIOREACTOR HARVEST CHROMATOGRAPHY UF & DF, Bulk Fill Formulation Fill & Finish Procedures of Contract Manufacturing of Biopharmaceuticals Drug products that can be administered to patients are determined only after manufacturing high-quality target proteins in the ‘Cell Culture’ process, extracting only the target antibodies to produce the drug substance (DS) in the ‘Purification’ process. The ‘Aseptic Fill/finish’ process is completed once all of these processes have been conducted. All manufacturing processes strictly abide by the global GMP standards. Samsung Biologics’ Unique Strengths for Contract Manufacturing Services Samsung Biologics currently has the world’s largest biomanufacturing facility in terms of capacity, with the ability to produce up to 364,000 liters at a single site. We have four plants at our site in South Korea. Plant 1 holds an industry standard of 30,000L, and Plants 2 and 3 each offer 154,000L and 180,000L respectively. Upon Plant 4’s completion in 2023, Samsung Biologics will hold a total biomanufacturing capacity of 620,000 liters while offering multi-scale manufacturing services from 1K, 2K, 5K, 10K, and 15K to flexibly respond to all of the clients’ needs at any scale. Plant 1 Cell culture capacity 5K x 6 = 30,000L Plant 1 Capability Liquid & Lyo vials Plant 1 cGMP ready Jun. 2013 Plant 1 Laboratories QC Laboratory Plant 2 Cell culture capacity (1.5K x 10) + (1K x 2 SUS) + (1K x 2 SS) = 154,000L Plant 2 Capability Liquid & Lyo vials Plant 2 cGMP ready Fed. 2013 Plant 2 Laboratories PD Laboratories Plant 3 Cell culture capacity 15K x 12 = 180,000L Plant 3 Capabillity Fed-batch with N-1 perfusion capability Plant 3 cGMP ready Oct. 2018 Plant 3 Laboratories QC Laboratory, PD Laboratories Plant 4 Cell culture capacity (15K x 12) + (10K + 6) + (2K + 8) = 256,000L Plant 4 Capabillity Multi-scale, digitalizations, automation, eco-friendly Plant 4 cGMP ready Expercted by. 2023 Plant 4 Labora
development and manufacturing organization (CDMO), published its first annual sustainability report, consolidating the company’s policies for an enhanced ESG management system and related plans. The report focuses on the company’s commitment to taking part in social responsibility over the past decade and its future plans for the next ten years and beyond. John Rim, CEO of Samsung Biologics, said, “The publication of our annual sustainability report showcases our aims to accelerate innovation and contribute to building a healthier future for all stakeholders. As we have always been since our founding in 2011, Samsung Biologics will continue to carry out its social accountability - creating a safer and healthier culture, reducing its environmental footprint, and increasing reporting transparency on ESG initiatives.” In the report, Samsung Biologics stated its plans to build an eco-friendly business environment, supported by recently awarded ISO Certifications for Energy Management (ISO5000) and Occupational Health and Safety Management (ISO45001). The company is also planning to install solar powered generators and introduce eco-friendly refrigerants to its Plant 4, which is currently under construction. The report also focuses on the various social activities Samsung Biologics has been taking part in, including a scholarship and mentoring program for students and medical care support for the most vulnerable members of the local community. Furthermore, the report exhibits the company’s collaborative efforts with its partners, including the support for domestic suppliers and localization efforts to improve supply chains. In February this year, Samsung Biologics established an ESG Committee to construct and supervise its managerial policies. The committee consists of four independent directors with expertise in the fields of management, economy, biotechnology, and law and systems. The committee is expected to closely monitor the ESG performance of Samsung Biologics moving forward. In order to stably supply biopharmaceuticals to the market while also protecting the assets of its clients, Samsung Biologics is operating under a robust and proactive management system. Since 2018, the company has obtained BCMS (Business Continuity Management System) ISO certification from BSI (British Standard Institution) and has recently been certified across all business areas. This extended achievement has reaffirmed Samsung Biologics’ capabilities to stably operate in a dynamic business environment whilst maximizing client satisfaction and fulfilling its social responsibilities.
development and manufacturing organization (CDMO), celebrated the one-year mark of Live Virtual Tour (LVT), a real-time interactive platform to provide remote site inspections for both clients and regulatory agencies. The innovative digital solution was developed and implemented at Samsung Biologics a year ago in the wake of the pandemic and has since been successfully utilized in over 50 virtual regulatory and client audits and inspections and counting. When many regulatory agencies and clients had postponed or completely discontinued GMP site inspections due to COVID-19 travel restrictions, Samsung Biologics proactively leveraged its process innovation to custom tailor a robust solution specifically to address the rigorous demands of a biopharmaceutical onsite inspection. Live Virtual Tour is an omni-device platform which allows third parties, such as the FDA and clients, to remotely observe and assess Samsung Biologics’ facilities, communicate in real-time, and review GMP documentation, all in high definition using a flexible and secure global cloud infrastructure. Since the launch of LVT, the company has utilized the platform for many aspects of its business, including technical due diligence and regulatory inspections including one of FDA’s earliest virtual assessment for Emergency Use of Authorization (EUA) of COVID-19 treatments, and more recently, EMA’s virtual inspection (“EMA distant assessment”) for six Pre-Approval Inspections (PAI) over the course of seven days, receiving no critical observations. John Rim, CEO of Samsung Biologics, said of the inspections, “While we have had many successful regulatory inspections in the past, these recent approvals, are meaningful milestones for Samsung Biologics. We will continue to adopt new technologies and stay abreast of what regulatory authorities require to help our clients secure robust and safe delivery of treatments to all patients around the globe.” The FDA issued a new recommendation in April providing guidance on remote inspections (“Remote Interactive Evaluations”) in light of COVID-19, suggesting that the FDA may continue to use remote inspections to supplement on-site audits post-pandemic. The European Federation of Pharmaceutical Industries and Associations (EFPIA) also predicts added value in retaining a virtual inspection system beyond the pandemic. By using all available approaches to ensure drug products are safe, effective, and of high quality, regulatory agencies agree that this form of evaluation is an effective and adaptive strategy for the duration of the COVID-19 public health emergency. James Choi, Samsung Biologics Senior VP and Chief Information and Marketing Officer said, “Our Live Virtual Tour platform not only fully complies with the regulatory agencies’ guidance on remote interactive evaluations but is also aimed at promoting greater client satisfaction through digital and virtual access to our site and quality documents.”
development projects for our clients. One of my primary responsibilities is to lead the project to success and ensure that every facet of our R&D activities runs smoothly, including the supply chain management. My job is to essentially create the right environment for our scientists to focus solely on the science aspect of the project. Another part of the job is coordinating with our headquarters in Songdo. As the first branch office outside of South Korea, it is essential for us to align all of our activities with the relevant divisions at the headquarters. What are some of the unique services that Samsung Biologics America is offering to our clients in the region? Samsung Biologics America provides the highest quality cell lines to produce antibody or protein drugs for our clients. Being closer to our clients in the same or similar time zone also allows us to provide real-time services. Our understanding of the entire biomanufacturing process gives us unique insights as we assist our clients in these end-to-end services. In addition to our holistic view of biomanufacturing, we provide unparalleled development capacities, which differentiate us from our competitors. Geographic expansion is a significant initiative for Samsung Biologics. Why is this so important? One of the most effective ways to expand the business is by being closer to the clients. Opening an R&D Center in the United States is significant because we can now engage with our clients in real-time. Our San Francisco office is a stepping stone for expanding into other regions in the U.S. and Europe. Lastly, our growing team will lead us in making technological advances in our development processes. As the new leader of Samsung Biologics America, how do you see us evolving in the next year, two years, or five years? We have ambitious plans to expand in the Bay Area and even further to other cities in the U.S. In the short term, we will expand our cell line development capacity at our current location. It is hard to predict our growth path now, but we have a history of setting high standards - just look back at how far we’ve come in such a short period of time. What do you see as the biggest strengths of our business in the U.S. right now? What are some of the challenges? It's the people. We are fortunate to have excellent scientists, and without a doubt, they are the most significant assets to our business. We care deeply about our team, and our administration works tirelessly to push SBA forward by bringing on new team members and making sure our operations are in order. We still have a long way to go, but we will not be where we are today without their dedication. Our strengths are also derived from Songdo. Our colleagues in Corporate HR, Finance, Legal, and CDO BU spent numerous hours initiating the projects and have supported us tremendously in opening the site successfully. We also face various challenges as do most other companies operating in these unprecedented times. Due to the pandemic, the supply of reagents and consumables for R&D is high in demand throughout the industry. Things that we took for granted in the past are no longer considered normal. We are currently directly working with our suppliers for timely deliveries and are putting in our utmost efforts to run our R&D activities as scheduled. What makes Samsung Biologics' culture unique? I am continuously amazed by the flexibility demonstrated by our company. Every aspect of our business aims to accommodate the clients' needs, even at the last minute. The tasks are not always easy as most of them require a lot of internal coordination and creativity, however with Samsung Biologics' highly collaborative culture, the organization can adapt to new business environments and ultimately increase efficiency throughout the process. When you hear th
development and drug product aseptic fill/finish services including biosafety testing. We are now providing a full array of biologic solutions from cell line & process development to both GMP and non-GMP clinical batch production.” > “With the sustainability and growth of the biotech industry in mind, our business planning includes 3 areas of expansion: 1) Capacity Expansion: Adding additional capacities and capabilities in Bio Campus II 2) Geographical Expansion: To improve client reach on a global scale as demonstrated by the opening of our US CDO R&D center last year 3) Modality Expansion: To provide more diversified, multimodal state-of-the-art infrastructure. As recently announced, we will be also adding a dedicated production suite for mRNA bulk drug substance to the existing facility by the first half of 2022, which will enable us to rapidly manufacture and supply future vaccines and treatments against multiple targets.” Wrapping up the speech on a forward-looking note, Rim said, “The ongoing global crisis brought us clarity about what is truly important and reminded us of the awesome potential of our industry in altering the course of devastation and bringing hope to the world. Our vision has been, and always will be, to achieve better life through biomedicines. And with the mission to enrich human life with technology and innovation, Samsung Biologics will bring you greater success faster.” What’s Coming Next? - A Conversation with Samsung Biologics from a CDMO Point of View On June 16th, Joon Young Chang, Senior Director of Global Sales and Operations Center, participated in an expert interview session to discuss the emerging trends of the CDMO industry and its partnerships highlighting the unique values that Samsung Biologics delivers to clients. EXCERPTS FROM SENIOR DIRECTOR JOON Y. CHANG’S SESSION > “The biopharmaceutical market has greatly expanded due to COVID-19, and the need to secure manufacturing facilities to stably supply biopharmaceuticals is increasing rapidly. As the demand for strategic partnerships with contract manufacturing organizations increases, it is becoming more important than ever to offer customized strategies and tailored services to meet the diverse needs of clients.” > “Upon the COVID-19 pandemic, 'distribution supply chain strategy' has emerged as an important discussion topic in the biopharmaceutical industry. Samsung Biologics has strengthened its supply chain network to enable stable manufacturing and supply of biomedicines even during a time of crisis, and has actively supported multi-sourcing for risk dispersion as well as localization.” > “Flexibility has also become a keyword in the way we work. Virtual meetings have become essential in our daily lives, and communicating with clients without time and space restrictions have become very important. This trend is expected to continue even in the post pandemic era. As transparent communication and collaboration are becoming more important, 'Digital Transformation' will be a major discussion topic in the future biopharmaceutical industry. Samsung Biologics has been proactively introducing digital technologies in response to the pandemic…Through virtual due diligence, we were able to conduct regulatory inspections and ultimately gain successful approvals for COVID-19 treatments, and we were able to deliver medicines to patients more quickly.” Next Steps in the CDMO Space & Beyond Also this week, Sam MacHour, Senior Vice President & Chief Quality Officer, joined Dan Stanton, Editor in Chief and Founder of BioProcess International, in an on-demand interview, where he discussed how both Samsung Biologics and the CDMO sector have rapidly responded to biopharma's COVID-19 challenges, and talked about how Samsung Biologics has emerged as one of the largest CDMOs in just a decade, as well as its great attention to quality control. EXCERPTS
development to IND filing process to enable seamless manufacturing of DSP502. Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, signed a strategic partnership with KAHR Medical Ltd., a cancer immunotherapy company developing novel multifunctional immune-recruitment proteins. Under the terms of the agreement, Samsung Biologics will provide its end-to-end cell line development and clinical drug substance and drug product manufacturing services as well as IND filling support for KAHR’s drug candidate DSP502, a TIGITxPD1 fusion protein. As an innovative leader in the fusion protein space, KAHR’s current technology is based on multi-functional immuno-recruitment proteins (MIRP) that bind cancer cells and T-cells to produce a synergistic effect to selectively target tumors. KAHR recently signed an exclusive license with Thomas Jefferson University in Philadelphia, PA to develop and commercialize multiple new drug candidates, including DSP502. “We are proud to announce our partnership with KAHR Medical for the production of their novel drug candidate,” said John Rim, CEO of Samsung Biologics. “We will leverage our fully integrated, scalable, and high-quality development services and experienced teams to enable a faster transition from gene to IND in order to ensure KAHR’s success in bringing cutting edge immuno-recruitment cancer drugs to patients in need.” "We are very pleased to partner with Samsung BioLogics, which is recognized as a leader in biopharmaceutical process development and manufacturing" said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "DSP502 focuses on promising checkpoint pathways, unleashing the potential of the immune system to enhance anti-tumor immunoactivity through dual checkpoint inhibition.” Samsung Biologics offers seamless one-stop CDO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Samsung Biologics’ CDO business brings quality-driven development services at a greater speed, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months at the fastest pace in the industry. The company is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire global bio-CMO capacity.
development and manufacturing services, today announced its plans to add mRNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022. mRNA has been the technology of choice for many COVID-19 vaccines due to its characteristics of safety and fast scalability in manufacturing. As part of the company's long-term strategy to become a fully integrated global biopharmaceutical company, Samsung Biologics has been expanding its business portfolio and production capacity to meet the rapidly rising market demand beyond its current business focused on monoclonal antibodies (mAb). “We are constantly assessing various ways that we can expand and persify our current business portfolio to better serve the market,” said John Rim, CEO of Samsung Biologics. “We are committed to helping our clients provide quality treatments and vaccines to all those in need around the world, especially in difficult times like this, and with this extended capability, we hope to support our partners in bringing novel mRNA vaccines and therapeutics to market at a faster pace.” In an effort to extend its global expansion and build a perse portfolio, Samsung Biologics has also opened its newest US R&D Center in the heart of the San Francisco biocluster, bringing its contract development services closer to biotech and pharmaceutical companies in the Bay Area. With its own proprietary cell line technology, S-CHOice, which shows enhanced cell viability and improved titers up to two-fold from the industry average, Samsung Biologics can facilitate reduced development timelines and high-performing product offerings. The company’s dynamic growth plan also includes the ongoing construction of its fourth and largest biomanufacturing facility in Incheon, South Korea. Upon completion of Plant 4, Samsung Biologics will hold a total of 620,000 liters of cell culture capacity and continue to provide end-to-end, start-to-finish services to its clients.
development and manufacturing organization, announced today that the company has obtained four global ISO certifications: ISO22301 (Business Continuity Management), ISO50001 (Energy Management), ISO45001 (Occupational Health and Safety Management), and ISO14001 (Effective Environmental Management) from the British Standards Institution (BSI), further advancing and reaffirming its capabilities to stably operate in a dynamic business environment whilst maximizing client satisfaction and fulfilling its social responsibilities. Upon meeting rigorous requirements and standards for ISO certification, the updated BCMS, ISO22301:2019, was awarded to Samsung Biologics’ Contract Development Organization (CDO) along with recertification for existing business areas, including Drug Substance and Drug Product, which was first certified in April 2018. Samsung Biologics is the first company to have earned the latest BCMS certification in South Korea and will now be qualified with the international accreditation across all of its business areas. “We are extremely proud to obtain four global ISO certifications during a time where a high degree sustainable management system is vital, especially in light of COVID-19, to stably operate and supply crucial biomedicines for patients,” John Rim, CEO of Samsung Biologics, commented. “Samsung Biologics is a leading CDMO committed to taking responsibility and consideration of ESG factors across all of our business areas, and we will continue to enhance our capabilities to meet the evolving needs of clients whilst ensuring the safety and security of not only our people but also of the environment to ultimately create a better future for humanity.”
development and manufacturing needs of clients. As a Senior Engineer on Samsung Biologics’ Drug Product Operations team, Rahyun Park sees flexibility as an integral part of her job in manufacturing, especially when unexpected issues arise. In her 5 years at the company, it’s been part detective work, part problem solving to identify risks and ensure GMP practices are upheld. Rahyun discusses why being proactively reactive moves us towards client satisfaction and how her role in Drug Product plays a part in our “Driven. For Life.” mission. What are your job responsibilities at Samsung Biologics? My job here is as a lead investigator responsible for deviation management and Corrective Action and Preventive Action (CAPA) planning. When some unexpected issue occurs during manufacturing or in our facility, my job is to find the root cause of the problem and see if the problem has any adverse impact on our manufactured batch or our facility, and then come up with a CAPA plan that can prevent recurrence. To deliver biopharmaceuticals more quickly while managing risks and regulatory demands, what are we doing to make our operations more integrated? The Drug Product Team and all other departments work very hard together to achieve the same goal, which is providing quality products in a timely manner. In order to meet the desired timeline, Samsung Biologics identifies most of the risks ahead even before a new product is introduced. That is possible because [we] incorporate all the risks from all previous products in a database, and we also assess any new updates in regulatory demands and promptly reflect them in our site. Why is flexibility so important in drug product operations? What does this ultimately mean for our clients? As drug product is the final manufacturing step before it goes to the patient, each manufacturing process is very different from product to product. There are stainless steel systems and single use systems, liquid product and lyophilized product, from small vial to large vial, and so on. To be able to manufacture all these kinds of products to be distributed over the world, flexibility in the DP line is very essential. With this flexibility, we can fulfill our client’s needs, which is one step forward to client satisfaction. What do you think is Samsung Biologics’ greatest achievement in DP so far? Samsung Biologics Drug Product has been approved from multiple regulatory agencies, including the FDA and EMA. It meant a lot for us, since it actually proves our capability. This achievement could only be made through our one-team mindset that embodies both the GMP (Good Manufacturing Practice) mindset and DP line flexibility that can meet our clients’ needs with the drive for success. What aspect of your job do you think has added the most value to the company’s long-term goals and why? As a lead investigator, it’s the in-depth investigation to be performed to find the true root cause. Finding a true root cause makes it possible to have a feasible Corrective Action and Preventive Action plan. With a solid and feasible plan, I can contribute to decreasing deviations and increasing the quality of our batches and ultimately the patients’ safety, which is part of our culture of being “Driven. For Life.” What makes Samsung Biologics’ culture unique? Samsung Biologics is pursuing a workplace where everyone has an equal voice regardless of job title. We call each other as ‘Pro’ [Professional], which makes it much easier to ask for help regardless of your job title or how much experience you have. When you hear the phrase "Driven. For Life.", what comes to mind? For me, I think Samsung Biologics is moving forward to seek a more ultimate goal. As a CDMO company, we manufacture products that are asked for, but those
development and manufacturing service, today announced a Manufacturing Services and Supply Agreement in which Samsung Biologics will provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine. Upon execution of the deal, technology transfer will commence immediately at Samsung Biologics’ facilities in Incheon, South Korea, utilizing a state-of-the-art production line equipped for aseptic fill-finish, labeling, and packaging services to support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine intended for the supply of markets outside of the U.S. starting in the third quarter of 2021. “This vaccine is paramount to people around the world in the fight against the COVID-19 pandemic, and we truly appreciate our client Moderna for entrusting and choosing to partner with Samsung Biologics for the fill and finish of this important vaccine,” said John Rim, CEO of Samsung Biologics. “Due to the high level of urgency in supplying the vaccine to the global population, we have set immediate action plans and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021.” “We are pleased to partner with Samsung Biologics for this fill and finish manufacturing, which will help us continue to scale up our manufacturing capacity outside of the U.S.,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “We and our manufacturing partners remain committed to defeating the COVID-19 pandemic.”
development and commercialization efforts through a diverse toolkit and operational agility, accommodating projects of varying scale with speed and flexibility in ensuring a sterile final product. In this whitepaper, Brian Bayly, our Head of DP MSAT, presents how our end-to-end capability provides clients with the expertise, experience, and infrastructure to support aseptic production, all while maintaining top quality and full regulatory compliance.
development services. New to Samsung Biologics is Yeonha Kim, a scientist in the Manufacturing Science and Technology DSP Group, who works on protocols and data verification. Discover how these two employees bring their unique perspectives to the company, and what “Driven. For Life.” means to them at such a significant time. How long have you worked at Samsung Biologics? Byul: It’s been 9 years and 10 months. It will be my 10th anniversary in July. Yeonha: I’ve worked at Samsung Biologics for three months! I’m a quite newbie here. What makes Samsung Biologics’ culture unique? Byul: So Samsung Biologics’ culture is unique in a way that the majority of the employees in our company are Korean [or locally hired] but we also have expats from outside of Korea, and blending the mixture of different cultures changes and impacts the way we work, the way we interact and communicate. So we try to find the best practice amongst all different cultures. Yeonha: Since coming to the [Samsung] Group, I've never felt afraid to ask questions because the people who I’ve met here provide an environment where I can always ask and learn…So that really motivates me to do better and want to contribute more to the group.
Byul, please tell us about the moment when you first joined Samsung Biologics. What was it like? Byul: I was first very happy to make it into Samsung because Samsung 10 years ago was very famous as the number one conglomerate in Korea…When I joined the company, there was absolutely nothing. Not even Plant 1, or even Songdo; the area was absolutely full of dirt and almost nothing… So from there up to where we are [now], it’s a great achievement. Not only from the plant construction perspective, but also from a business standpoint, we have grown and we’ve made a successful showing of our achievement…I think with our scale, with our business, and with our relationship with the clients, we’ve been very successful in helping biopharmaceutical companies to develop and manufacture their products…so that they can do the necessary work to get it to the patients. What significant changes have you observed throughout the last 10 years? Byul: Ten years ago working for the company, there was still a huge uncertainty. Now we have a very clear goal. We have a goal for our success in terms of revenue, business, portfolio - these targets are very specific. But back then, it was a huge blank. There was just so much potential, but at the same time, it was harder for us to define because this field [contract manufacturing in Korea] not many companies were trying it at the time…We lacked this track record, and we did not know what we should benchmark or reference. I think that’s the huge difference right now compared to 10 years ago.
This question is for Yeonha. As a new employee at Samsung Biologics, what was your first impression when you joined the company? Yeonha: Actually my time at Samsung Biologics didn’t start this year. It was last summer when I was very lucky to be a part of the 2020 global interns…The people who I’ve met here, they are so welcoming and ready to answer my questions, and all of these things made me realize that this is the place where I can become and grow as an expert, a scientist, and also as an individual. After coming to the MSAT DSP Team, I realized that MSAT actually handles a lot of things…[Working for MSAT] you need to know how to plan and write documents…how to handle chemicals, and also know how to not only communicate with clients externally but also within the team internally.
development and manufacturing organization, today announced financial results for the first quarter of fiscal 2021. John Rim, CEO of Samsung Biologics, stated, “Our first-quarter financial performance was in line with our expectations and provides us with a strong start to the 2021 fiscal year. We have maintained a solid performance, and continue to see momentum from our expanding CDMO business globally while simultaneously making continuous advancements in our biosimilar subsidiary and new business models. As the world continues to navigate the difficult times amid COVID-19, we remain committed to supporting our clients and patients in delivering life-saving therapeutics in a timely manner.” FIRST QUARTER 2021 RESULTS First quarter 2021 revenue was KRW 260.8 billion, an increase of 26% from KRW 207.2 billion reported for the first quarter in the previous year, attributable to the expanded sales volume at Plant 3 for its full-scale operation. First quarter 2021 operating profit was KRW 74.3 billion, 19% higher than the prior-year period due to Plant 1 and 2's stable operation and the gradual increase in Plant 3 operation for its early lock-in orders. First quarter 2021 net profit reached KRW 61 billion, an increase of KRW 24.2 billion from KRW 36.8 billion in the first quarter a year ago, showing a direct reflection on improved profitability and sales at Plant 3. [KRW billion] Q1’21 Q1’20 YoY Change Revenues 260.8 207.2 +53.6 Operating Profit 74.3 62.6 +11.7 EBIT 79.8 47.9 +31.9 Net Income 61.0 36.8 +24.2 FISCAL YEAR 2021 OUTLOOK Continuing on the strong performance from the fiscal year 2020, all existing Samsung Biologics plants are at near full operation. The construction of Plant 4 remains on track with active pre-sales discussions. The US R&D Center is fully equipped and operational, and the company’s growth plans remain active. Since there have been no disruptions to business continuity caused by the challenges amid COVID-19, the company has maintained stable business operations and is currently able to continue as planned with key strategic growth projects and long-term investments. For more detail on performance and financials, please refer to the Earnings Release.
development and manufacturing organization and TG Therapeutics (NASDAQ: TGTX), today announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication. “We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” John Rim, CEO of Samsung Biologics, commented. Rim added, “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.” Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.” In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients. ABOUT UBLITUXIMABUblituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.
development and manufacturing organization, celebrated the 10th anniversary of its founding today at its global headquarters in Songdo, Incheon via a virtual ceremony. John Rim, CEO of Samsung Biologics, stated, "Ten years ago, we had the vision to enrich people's lives through technology and innovation. Now heading into the next decade, we see a clear path before us. Our 2030 vision is to become a global top tier biopharma company, with the mission to make high quality, safe treatments more accessible to patients around the world." Samsung Biologics also introduced its new mission statement, "Driven. For Life." representing the company's purpose, commitment, and unrelenting will to build a better future for all humanity. Rim said, "Samsung Biologics does not just develop and manufacture products, but produces life-saving solutions. We are driven, for life." Since its launch in 2011, Samsung Biologics has achieved significant and meaningful milestones: the world's largest biomanufacturing capacity at a single site at 364,000 liters, over 85 regulatory approvals from global agencies, and a growing list of 70+ clients from all over the world within a decade. Responding to the rising demand in biopharma, the company is currently building a fourth manufacturing plant in addition to its existing three state-of the-art facilities, when combined will account for approximately a quarter of the global CMO production at a 620,000-liter total capacity upon its completion. The company recently expanded its global footprint with the opening of its first US R&D Center in San Francisco, CA and announced plans for further geographic expansion and portfolio diversification in the coming decade. "The work we do today with cutting-edge innovation and technology impacts a better tomorrow for humanity," Rim said. "We are driven to discover, develop and manufacture breakthrough solutions to save lives, and are only just getting started." He added, "I'd like to thank all our clients, partners, and employees from across the globe for helping the company get to where it is today."
developmental journey is represented with cell line development. During this exciting milestone, a suitable cell line must be selected for optimizing the remaining processes at the highest output. Where reducing time to market can determine a key factor for a successful business, selecting the right pathway from the start is critical to prevent any future risks. In this session, Samsung Biologics, as an integrated CDMO partner, will explain how we provide tailored solutions to suggest what to consider in selecting the best cell line to accelerate speed to market.
development and manufacture of vaccines and neutralizing antibodies. However, tech transfer remains a critical, time-consuming step on the path towards large-scale production of therapeutics in such times of crisis. Here we describe the acceleration of tech transfer to enable kickoff to vial thaw for antibody manufacture within three months for a clinical program and within five months for a process qualification campaign. We demonstrate various approaches to reduce the timeline from development to manufacturing at a 15kL scale. We also discuss the implications of this work towards enabling a rapid response to future pandemics, as well as introducing routine accelerated tech transfer to our site.
Unprecedented challenging time also provides opportunities for a great advancement of innovation with cooperation. In this session, learn about- Close collaboration and communication with all stakeholders, utilizing the latest technology, establishing a robust business contingency plan, and eliminating a lead time to deliver drugs on time stably- Accelerate timelines by streamlining the process- Few case studies of our innovation to deliver drugs in just 3 months and how Samsung Biologics goes the extra mile
development to the final drug product. We support our clients in the clinical and commercial DS manufacturing, have the capability for aseptic fill-finish services, and finalize it all with biosafety testing services. So when clients work with Samsung Biologics, they don’t have to look elsewhere to perform any additional services. We can truly say that we are a one-stop shop to all of our clients. What are some of the advantages Plant 4 will offer to clients?The reason that our clients are excited about our newest plant is that we are able to offer the world’s biggest manufacturing capacity at 256,000L. We are able to provide various bioreactor scales from 2,000L, 10,000L, and 15,000L, so our clients have the flexibility of choosing [their preferred scale] whatever stage they may be in. Therefore, Samsung Biologics is not fitting your products into what matches us but what matches your products’ manufacturing needs, based on a number of factors such as annual demand and titer/yield to properly fit each client to various bioreactor scales. I think that is one of the biggest advantages. Because of the pandemic, a lot of CDMOs are very limited in offering available capacities to clients. That’s why it is so remarkable that we will be able to bring this new plant to commission in 2023, so that we can accommodate and help our clients bring medicines to patients. How do we integrate all these services for client satisfaction?I think there is a reason why Samsung Biologics has grown and matured relatively faster compared to other CDMO companies. The reason is that Samsung Biologics really tailors our services to our clients. What that means is that because we have worked with so many clients—global clients, not just local clients—we understand what their needs are. We have dedicated members from MSAT, manufacturing, project management, quality, and other teams that work as one team. What is one of the best practices that we’re doing to maximize client satisfaction?There are many practices that Samsung Biologics offers to our clients. Open communication, transparency, and adaptability. The reason I say adaptability is that because of the global pandemic and with global travel being restricted, we were still able to accommodate our clients with Live Virtual Tour. As a matter of fact, the first FDA inspection was accomplished virtually here at Samsung Biologics. So despite the global pandemic, we were able to offer different solutions for clients so that their business can continue without any interruption. What do you love most about working at Samsung Biologics?The people are really passionate, especially about the company. As we are expanding our footprint worldwide, including the recent opening of the San Francisco CDO R&D Center, we also have plans to expand to the US East Coast, Europe, and China. There will be many opportunities in the future for all the employees to play a crucial part to become a global CDMO leader. I feel the passion and energy from everyone here at Samsung Biologics and every employee wants to play a role and help Samsung Biologics to become a better company that can address and identify all patients’ needs in the future. What makes Samsung Biologics’ culture unique?I would say Samsung Biologics is unique in a way that every time I come to work here, I feel a positive vibe from every employee that I encounter…The company itself and the executives are really encouraging employees to learn about their roles, and then work closely with other teams so that they can be a resource to one another. As part of our culture here at Samsung Biologics, we always say yes—so whenever a junior member asks a question or says “I need your support,” we always put our things aside and try to help. What that tells me is that we really want to grow as a company, and the main resource is our employees. I can sincerely feel that our management is putting so much investment into our employees. When you hear the phrase “Driv
development cycles, keeping you competitive in a rapidly evolving market. Of course, the process of selecting the right CDMO partner needs to be performed after careful analysis of many factors. Speed to market, efficiency at scale, and operational knowledge bases are critical factors developers must consider when deciding to manufacture mAbs internally or through a contract manufacturer. This article provides the key parameters to consider to make better decisions for your future manufacturing strategy.
development manufacturing organization, we transfer and manufacture various biotherapeutic products for our clients. I do tech transfer activities on the MSAT team, mainly on the upstream cell culture process with a focus on the manufacturing process. To demonstrate robust manufacturing by complying with all the quality and regulatory requirements, we, as a group, analyze and understand the client processes, and transfer those processes to fit to our equipment, procedures and manufacturing scale. So basically, MSAT is involved in every product we manufacture either for clinical or commercial use. What makes Samsung Biologics’ culture unique? At Samsung Biologics, there are people you can communicate with who come from different backgrounds, various cultures, and experiences…People listen to you and they all enthusiastically work to achieve their personal and career goals. One other item that I want to add is that Samsung Biologics is such a fast growing company. When I first joined the company, there were about 500 people. Today, it’s about six times larger and growing every day, not only in size, but also in success and achievement, which is a testament to the dedication, collaboration, and innovation of everyone involved. What is the Bio Women’s Club? The Bio Women’s Club is an organization [within the company] that supports women to foster their professional and personal achievement. In each and every department, there is a manager who can support as a mentor, and as a listener or friend…We reach out to our female employees by hosting seminars, and through mentorship at every level. Why is it important for women to have this sort of space?Women make up about 40% of the total employees in Samsung Biologics…With marriage, pregnancy, and childcare, there are a number of challenges that we may face, which can affect our work-life balance as well as our careers. The Bio Women’s Club would like to be a platform where we channel [any issues we may face] to create a more inclusive and better environment for all women. In the future, what kind of leader do you want to be?I want to be a leader who motivates others and has a clear vision. It's my intention to develop my skills as a scientist and hopefully as a facilitator who inspires and leads others. But at the same time, I strive to have a well-balanced life between work and personal needs as a career woman. When you hear the phrase “Driven. For Life.”, what comes to your mind?I see this phrase as a message to everyone involved to be proactive. In order to be proactive, you need to understand your sense of self. It is the ability to see ourselves clearly to understand what we value, and to be able to answer the question: ‘Who do you want to be today?’ To a company, it is a message to be a proactive force and a positive force for change in the world. People drive change. Holistically, I would describe "Driven. For life." as facing new challenges and persistently attempting to achieve the goal for a better life. Related Contents YouTube Benefits and Amenities at Samsung BiologicsYouTube Seahee Kim | Principal Scientist in Cell Line Development YouTube Jo Beth DeFreitas | Principal Specialist & Team Leader in QA
development activities with technology transfer and cGMP manufacturing. This alignment allows for rapid technology transfer with robust and compliant manufacturing. In addition, the alignment of process development with regulatory requirements allows Samsung Biologics to provide a comprehensive regulatory CMC data package including process controls, validation, product comparability, and stability. On-demand Webinar Link
development, manufacturing, and testing services, all from a single location. We provide highly tailored solutions to clients, while meeting the evolving needs of the global healthcare industry. With proven regulatory approvals, Samsung Biologics is a trusted CDMO partner of choice and is uniquely able to provide seamless offerings from cell line development to final fill/finish as well as laboratory testing services at every stage for biopharmaceutical products. We are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise. ◆ Description- Time Frame: 6/28~8/6, total 6 weeks (2 weeks online + 4 weeks onsite)- Location: Samsung Biologics – Songdo Bio Campus- Eligibility:1) Currently enrolled in a Bachelor’s or Master’s program2) Permitted to travel overseas3) Fluent in both English and Korean (working level proficiency or above) ◆ How to apply (※ Schedule subject to change)1) Application Submission Period (2/22 ~ 3/9 5pm, KST)- Submit your online application form (https://forms.gle/7LFp5AdqJqEkZCbF6)- We encourage you to apply as soon as you are ready2) Video Interviews (Mid-March)- Selected candidates from the application screening process will be invited to attend our Video Interview (via Zoom)3) Final Result Announcement (April)4) Internship Period (6/28 ~ 8/6, total 6 weeks) ◆ Internship Benefits- In addition to exciting hands-on experience, Samsung Biologics will offer an internship stipend, daily transportation, accommodations (if necessary), free meals, etc. ◆ Contact UsFor any inquiries, please contact firstname.lastname@example.orgCurious to see what a day in the life of a Samsung Biologics intern is like?Watch our video: https://youtu.be/lSG0sfeUUvw
development, manufacturing, and commercialization of a product, tech transfer requires careful planning, evaluation, and a bit of ingenuity to meet project timelines efficiently while maintaining high quality. Samsung Biologics' innovative processes help our partners accelerate the global supply for COVID-19 antibody therapies. In addition to delivering an initial supply within five months of signing the contract, the team was then able to dramatically reduce the timeline for tech transfer to less than three months. Kevin shares with us how the tech transfer team managed this extraordinary feat, as well as what being “Driven. For Life.” means to him. What are your job responsibilities at Samsung Biologics? As a project manager for tech transfer, I jump in right upon contract execution and schedule activities, see what the critical paths are, and come up with contingency risk mitigation plans. I also gather cross-functional teams and lay the groundwork for those teams to work together. You can consider my role as the main point of contact for any issues as well. We are at the forefront of client communications. Can you give us any insight behind how the team shortened the tech transfer process from five months to three months? What was the most difficult part of this process? Time was the critical obstacle for us to overcome. There were three key areas that we looked into when we went about expediting this tech transfer. First was thinking about a critical path, the second was establishing the contingency plans, and the third was developing seamless collaboration internally and externally. For the first part, in terms of critical path items, we focused on time—definitely RMs, CAPEX, manufacturing documents, and anything that has a longer lead time. We wanted to focus on whether we can get these on-site and on time, then develop contingency plans to mitigate risks. So we identified the critical path, found out the pain points, came up with solutions, and worked cross-functionally to execute those solutions. Most importantly, this would not have been possible without the diligent effort from cross-functional project members. Why is this so unique? When you think about tech transfer for a biopharmaceutical plant, we had our standard set at six months, but even that itself is very short. When we communicate that to clients, it's a surprise to them. So when we think about shortening that further, even like 50 percent to three months, that's extraordinary if you consider it in terms of industry standard, especially for large, 15kL commercial scale facilities. I think what's unique about Samsung is our ability to maintain quality while increasing speed, so we're not giving up anything…We're executing, delivering, and we're following all the quality measures to deliver results in a short amount of time. When you hear the phrase " Driven. For Life.", what comes to mind? “Drive” for me has two very distinctive meanings. The first is motivation. When you're motivated for something, you say the person has the drive for it. Drive also means power, or momentum. So we start with that motivation, and then we execute and deliver with drive, power, and momentum. It covers [everything] from the starting point to the endpoint where we need to deliver. And at the end of it, there's life! We're saving lives, and “Driven. For Life.” especially captures everything we stand for. We've seen that our employees are driven to make the world better in many areas. Innovation especially plays a vital role in tech transfer. How are you driven to inspire innovation within the company and within your job? Innovation is a very important word in all industries, but in terms of the biopharmaceutical industry, innovation is something that people want to be careful about, because of all the regulations and the impact that innovation could have when you’r
Development (CDO), and Contract Testing services (CRO), offering convenience for clients and industry professionals with the resources they need. Throughout the experience, users can also request one-on-one meetings at the click of a button. LIVE VIRTUAL TOUR (LVT) On-site virtual inspections for clients and regulatory authorities are vital for biopharmaceutical companies as this often leads to a successful contract signing with major biotech companies. Samsung Biologics has also conducted dozens of inspections per year; however, on-site inspections and tours became difficult to conduct with the pandemic situation. Therefore, we've implemented the Live Virtual Tour (LVT) to allow for global clients to access our facilities via a live-streaming platform and take a scheduled tour, audit, or inspection at their convenience. The platform also leverages a global on-demand cloud infrastructure to optimize speed and connectivity for clients and regulatory bodies from any location. Virtual Inspection Samsung Biologics has the world's largest manufacturing capacity at a single site. Inspecting the facilities for cell culture, purification, material storage, and utilities requires a great deal of time. Through real-time, high-definition visual tours, clients and regulatory agencies are able to access our facilities from any location, along with documentation reviews. We've gained a tremendous amount of positive feedback from clients and regulatory agencies through this real-time virtual tour system while also supporting our teams to conduct inspections for authorizations more efficiently. Secured Access, On Demand In 2020, we implemented the Enterprise Quality Unified Information System (EQUIS), which integrated two separate systems—Enterprise Document Management System (EDMS) and Enterprise Quality Management System (EQMS)—into one. EQUIS allows our employees to manage quality records and documents in real-time on a single platform, ultimately improving cGMP record tracking, documentation, and assessment. As a cloud based system, EQUIS gives clients direct secure access to request, review, and approve documents and records related to their products on-demand. As COVID-19 continues to cause significant shifts in people's lives, our ongoing efforts are to continuously invest in leading-edge technology platforms and digital innovation to ensure client satisfaction. Through this digital transformation, we are finding new ways to virtually connect with clients, regulatory bodies, and industry professionals. These innovative solutions not only drive enhanced client experience with efficiency and advanced mobility, but also position Samsung Biologics to advance the future of biopharma.
development program, approached Samsung Biologics for the development of EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody provided by Eutilex. Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade.“We are extremely glad to be notified of EU101(NOV1801)’s IND approval from the FDA,” said John Rim, CEO of Samsung Biologics. “This is our third IND approval demonstrating our unparalleled quality and speed, and as our CDO business continues to expand geographically in the next decade, we look forward to assisting many more clients in bringing their products to market faster and better as the most qualified CDMO partner.”Young-Whan Park, president of NOV, said, “In order to conduct the domestic and global clinical trials of EU101(NOV1801) in parallel, we plan to file another IND with the Ministry of Food and Drug Safety in Korea within the first half of this year, working together with Samsung Biologics.” Dr. Soo Young Choi, COO of Eutilex, added, “In the US, we will be able to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) through Phase I of clinical trials within the first half of the year.”Samsung Biologics’ CDO business has shown rapid growth and success since its business expansion, signing over 60 CDO contracts within two years to obtain three IND approvals by the FDA as well as one Clinical Trial Application (CTA) approval by the EMA. Leveraging Samsung Biologics’ extensive expertise for the submission process, the successful IND was achieved with no further significant comments from the regulatory agency.
development. “Our next decade will be marked by increased business expansion and portfolio diversification. While continuing to achieve best-in-class CDMO services and become a champion in the biosimilars business, we will also lay the groundwork for novel drug development, to ultimately become a full-service biopharmaceutical company,” said John Rim, CEO of Samsung Biologics on Wednesday in his presentation at the Main Track of the conference, held virtually this year due to COVID-19. To support the company’s long-term vision, Samsung Biologics announced plans to secure manufacturing facilities overseas in addition to outlining its global CDO R&D Center in multiple locations. Rim noted that product diversification from mAb/fusion protein manufacturing to encompass future modalities such as vaccines and cell-gene therapies are also being studied, and the company is further venturing into new business models for its growth roadmap. Samsung Biologics signaled a strong year in 2020, signing over $1.7 billion in CMO contracts – a record-breaking figure – and opening the company’s first overseas CDO R&D center in San Francisco. The company also proactively developed multiple new platforms such as virtual exhibition hall and live-streaming tour technologies to enhance virtual connectivity with global clients and regulatory agencies by offering convenience and agility amid the COVID-19 pandemic. Rim announced the company’s primary focus for the current year will be to accelerate Plant 4 construction to meet global demand, and secure early contract lock-ins for the aforementioned “Super Plant” as all other plants are expected to be near-full utilization in 2021. “The strategic investments and portfolio diversification outlined today signify the momentum in our business, as well as lay the foundation for the long-term growth opportunity ahead of us,” Rim added. “We will look beyond the next decade and evolve as the global top-tier biopharmaceutical company by securing future growth engines with continued investment and expansion in capacity, portfolio, and global footprint.”
Development, and Research and Development in the US and Europe. John has also held senior leadership roles with Astellas Pharmaceuticals in General Management, Sales & Marketing, Technical Operations, Customer Service, Business Development, and Strategic Planning. John has over 30 years’ experience in the biopharmaceutical industry and began his career as a management consultant with Booz, Allen & Hamilton consulting to pharmaceutical companies in the US and Europe. “I am deeply grateful and excited by the opportunity to lead Samsung Biologics into the next decade,” said John Rim, CEO of Samsung Biologics. “This is an extraordinary company, unparalleled in its phenomenal growth and dedication to client satisfaction, made possible by the company’s unrelenting vision and passion, and business ution by great people whom I will have the privilege to lead as CEO.”Samsung Biologics has shown strong performance throughout the year with a continuous increase in sales volume across all plants, stable business and supply management, and global business expansion including the opening of its first US CDO R&D Center in San Francisco. The company also recently commenced construction of its fourth plant, which is expected to further boost the company’s competitiveness in serving the growing global demand for CDMO scale and flexibility.
development of single-use systems for biomanufacturing, the lingering question is “Which system is better; Single-use or stainless steel?” For anyone that has looked into this topic, the answer is not black and white. In this BIO Digital 2020 presentation, Justin Carbungco, Associate Director of sCMO at Samsung Biologics, focuses on the cost comparisons for stainless steel and single-use systems, and some considerations for companies that are looking into clinical and contract manufacturing.
development timeline is directly related to obtaining IND clearance and starting your Phase 1 Study faster. At BIO Digital 2020, John Gill, Director of Cell Line Development at Samsung Biologics, describes how you can get to IND faster through our accelerated & high-performance proprietary cell line, S-CHOice. In addition, we present the combined benefit with S-CHOice and a two-step purification platform, which can further expedite the timeline and reduce manufacturing costs.Our CDO services provide a full scope of development to help our clients reach IND from cell line development, process development, to non-clinical and clinical material manufacturing.
development to cGMP clinical and commercial manufacturing (DS/DP) and biosafety testing services—all from a single location. With client satisfaction as our main priority, we provide highly tailored solutions using the most advanced technology to deliver product efficiently and effectively. Learn more about what we offer as well as how our multi-scale manufacturing facilities provide us with the flexibility to accommodate our clients' needs.
development to clinical production, Samsung Biologics' CDO team of experts offers dedicated and flexible services for our clients at every stage of their needs. Watch the video to learn more about the journey a molecule takes to get to the market faster and better with our CDO services. We promise the best.
development capabilities and large-scale commercial manufacturing with a full QC Lab. “We are committed to bringing client satisfaction to the next level. Plant 4 will add unbeatable value to our capabilities to develop and manufacture bio-medicines with the highest quality and innovative technology,” said Dr. Kim, “We will continue to invest, create jobs, and serve our valued clients as CMO, CDO, and CRO Champion in making life-saving drugs more accessible for all.” Samsung Biologics plans to also unveil a dedicated Plant 4 virtual showroom online early next month to provide more detailed information and ongoing construction updates of its new plant as part of the company’s enhanced digital transformation efforts. Learn more at www.samsungbiologics.com/plant4
development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity aq -t a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com. Lilly Forward Looking StatementsThis press release contains forward-looking statements about the supply and use of Lilly antibodies to treat or prevent COVID-19 and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly antibodies will prove to be safe and effective to treat or prevent COVID-19, that Lilly antibodies will receive regulatory approval, or that Lilly can provide an adequate supply of Lilly antibodies in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. Samsung Biologics Forward Looking StatementsThis press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics’ objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.
development and manufacturing, it is critical to embrace digital transformation for securing biomanufacturing quality. Please watch to see how Samsung Biologics defines digital transformation and how our Contract Research Organization(CRO) is achieving client satisfaction by digital transformation by creating more transparency across the value chain.
development and manufacturing organization (“CDMO”) service provider, Samsung Biologics offers the highest quality manufacturing for Checkpoint to assist in its endeavor to bring innovative treatments for patients all around the globe.” Samsung Biologics recently announced it will break ground on its fourth plant within this year to commence manufacturing activities in the latter half of 2022, deliver world-class client satisfaction, and fulfill the needs of the growing biopharmaceutical market. About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma (“CSCC”) is the second most common human cancer in the United States, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, CSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. About Cosibelimab Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types. About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to support one or more applications for marketing approval. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com. About Samsung Biologics Co., Ltd. Samsung Biologics Co., Ltd (“Samsung Biologics”) (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting
development services closer to global clients. As the “Next Door CDO Partner,” the Company aims to maximize client satisfaction and provide immediate convenience to biotech companies in the Bay area. Tapping into San Francisco, the birthplace of biotech and one of the fastest developing bioclusters, Samsung Biologics will provide real-time interaction and be in closer proximity to potential and existing clients in the region. Aligned with the Company’s mission to offer a seamless one-stop service, the new facility will utilize the same CDO research and development capabilities present at its headquarters in Incheon, South Korea. Samsung Biologics’ CDO business brings quality-driven development services at a greater speed, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months at the fastest pace in the industry. “We’re starting the CDO R&D Center today in San Francisco, and we plan to continue our expansion into Boston, Europe, and China moving forward. In 2020 and beyond, our next decade will be marked by global geographical expansion,” said Tae Han Kim, CEO of Samsung Biologics. “Samsung Biologics will continue to provide biopharmaceutical development and manufacturing services with top-notch capabilities and capacity, so that biotech and pharmaceutical companies can focus on their expertise: the discovery, development, or marketing and sales of novel biologics for patients.” Recognized as a CMO Champion for its excellence in capabilities and reliability, its goal is to become CDO champion by 2025. Since its launch, the Samsung Biologics’ CDO business has been growing at a fast rate, contracting nearly 60 projects within just two years and establishing its proprietary cell-line, S-CHOice, showing improved titers up to two-fold from the industry average and maintaining over 90% cell viability. Leveraging the Company’s operational excellence, Samsung Biologics plans to go above and beyond by offering end-to-end service from the early stages of discovery to the final manufacturing of drug products in a shorter development time. With its experts working “next-door,” the newly opened San Francisco CDO R&D Center will bridge Samsung Biologics with its biotech clients in its first step towards global expansion in providing optimized satisfaction and even greater convenience with faster and better service offerings.
development partnership with an innovative biotech, APRINOIA Therapeutics, further marking the company’s strategic entry and presence in the market. GeneQuantum had previously signed its CDO contract with a CDMO partner for its first asset, however has notably chosen Samsung Biologics for its second antibody candidate. As a result of Samsung Biologics’ recognized capabilities to achieve best-in-class client satisfaction, the company is currently having extensive discussions with a vast number of potential Chinese clients in the market. Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for development stage, taking 6 months to DS manufacturing, and 7 months to DP manufacturing. Samsung Biologics has also recently announced its proprietary cell line technology, S-CHOice, in August this year, which shows improved titers up to two-fold from the industry average and maintains over 90% of cell viability. Owing to these proven features, the company’s CDO business unit has acquired nearly 60 contracts within a 2-year period, gaining recognition in the global market. Through these extended partnerships, especially with leading Chinese biotech companies, Samsung Biologics aims to further demonstrate its high-quality CDO capabilities and technology in the Chinese market to provide greater accessibility to breakthrough treatments for patients. "GeneQuantum is excited to collaborate with Samsung Biologics, a global leading partner with proven development capabilities in the market,” said Dr. Gang Qin, CEO of GeneQuantum. "One of the decision-making aspects for this partnership was Samsung Biologics’ dedication and commitment to providing high-quality services. With this mutually beneficial partnership, we aim to further expand on this development scope to bring innovative treatments for patients." “We are extremely proud that our CDO capabilities are continuously being recognized in the Chinese market, especially amid the current global climate,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “By joining forces with a leading biotech company with a distinguished reputation in the market, we hope to further expand on the partnership to provide effective and affordable treatments for patients with unmet medical needs.” About Samsung Biologics Co., Ltd.Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity at a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com. About GeneQuantum HealthcareGeneQuantum Healthcare (Suzhou) Co., Ltd. is a privately held, innovative biotech company dedicated to the development of First-in-Class and Best-in-Class biologic drugs. The company is focused on the development of a new generation of bioconjugate therapeutics to meet the unmet medical needs of cancer patients globally. For more information, visit www.genequantum.com.
development services from cell line development, process development, to non-clinical and clinical material manufacturing. Under this agreement, Samsung and Dinona will collaborate for fast-track development of DNP-019, a potential COVID-19 antibody therapy. Since its inception, the Samsung Biologics CDO business has been growing at a rapid pace with near 60 contracts signed in just two years. The business segment continues to expand its market reach through a cumulative track record of various biologics products beyond monoclonal antibodies and by targeting diverse treatment areas including cancer, neurodegenerative diseases, and as with this partnership, COVID-19 treatment. Samsung Biologics has also recently introduced its proprietary cell-line technology, S-CHOice, this year showing improved titers up to two-fold from the industry average and maintaining over 90% cell viability. With a customized development strategy, Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for the development stage, taking six months to clinical material manufacturing and seven months to DP release. “Samsung Biologics is always committed to providing the highest quality services to our clients globally to help biotech companies like Dinona focus on their core business, which is drug discovery,” said Tae Han Kim, CEO Samsung Biologics. “As with all our partnerships, we will closely collaborate with our client Dinona to provide the highest client satisfaction and support in its endeavor to bring a potential COVID-19 treatment to market faster and better.”
development services from cell line development, process development, to non-clinical and clinical material manufacturing as well as IND filing support. “Partnering with BioEleven reinforces the key value of our CDO business model: to support our clients with faster and better services in their efforts to help patients in need all around the world,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “We thank BioEleven for putting trust in our services, and look forward to seeing what this partnership will accomplish.”
development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line, S-CHOice. In addition, we present the combined benefit with S-CHOice and 2-step purification platform, which can further expedite the timeline and reduce manufacturing costs.
development, process development, non-clinical and clinical material manufacturing to IND submission. "We are proud to announce our partnership with Kanaph Therapeutics for the development of their first biologics program," said Dr. Tae Han Kim, CEO of Samsung Biologics. “This partnership marks our standing as the most reliable CDMO partner with leading capabilities of providing high-quality development services. We will leverage our extensive expertise to expedite Kanaph Therapeutics’ success in bringing advanced treatments for retinal disease to address the unmet medical needs of patients.” “We have decided to work with Samsung Biologics for the development of our first biologic program, in preparation for our global clinical trials,” said Byoung Chul Lee, CEO of Kanaph Therapeutics. “This will mark the beginning of many biologic molecules in our pipeline to be developed for the clinic. In addition to partnering with a global CDMO such as Samsung Biologics, we will drive for the successful outcome of our regulatory and clinical strategies in partnership with our specialized KOLs and experienced CROs.”
development represents a pivotal moment in a biologic’s broader developmental life cycle. Optimal cell line development is crucial for successfully navigating clinical trials and challenging regulatory approval processes. To reduce time to market and keep costs low, many developers prioritize speed over strategy, risking expensive and disruptive redevelopment mandates. To mitigate risk and deliver superior product quality, cell line developers should possess the deep technical expertise, sufficient resources, and long-term business strategy to achieve value instead of bottlenecks.In this whitepaper, Samsung Biologics explains how effective, strategic cell line development positions your product for regulatory and commercial success. When it comes time to develop your cell lines, here are the crucial factors to consider: The importance of developing a top-quality cell lineThe importance of developing a top-quality cell lineAligning early development efforts to key IND and BLA parametersStaying flexible to control your time and costsEmphasizing collaboration with specialist partnersLeveraging a CDMO’s knowledge of resource and risk mitigation planning helps you visualize your goal prior to uting development, helping you stay on course during moments of turbulence. Fully integrated organizations are better equipped to consider how early stage development can affect the overall product’s life cycle Read more to find out how Samsung Biologics is transforming cell line development for clients worldwide.
development services from cell line development, process development, to non-clinical and clinical material manufacturing. According to Panolos, PB101 is expected to suppress tumor angiogenesis more effectively by targeting VEGF-A and PlGF simultaneously, overcoming the limitations of existing treatments. Leveraging Samsung Biologics’ robust capabilities and expertise in developing complex proteins, Panolos intends to achieve successful IND approval for validation to further establish the substance as the new platform known as αARTTM(anti-angiogenesis-based Artifact Re-targeting Tri-specifics) to treat various VEGF related illnesses. Dr. Hyeseong Lim, CEO of Panolos Bioscience stated, “PB101 is itself a promising candidate as a treatment for solid tumors and VEGF-related diseases. Furthermore, it is also a platform technology that has demonstrated its versatility as a foundation on which multi-specific biologics can be developed. Through close collaborative efforts, Panolos will endeavor to deliver quality biopharmaceuticals to address global unmet medical needs.” “We are extremely proud to be partnering with Panolos in bringing PB101 closer to market,” said Dr. Tae Han Kim, CEO Samsung Biologics. “By delivering faster and better development services and helping our clients focus on discovery, we will continue supporting biotech companies in their efforts to help patients in need all around the globe.”
Development, and Beomkyu Kim, Lead Scientist of Downstream Process Development, will discuss how we combine S-CHOice and 2-step purification platform together to further expedite the 3 months cell line development timeline and reduce the manufacturing costs. To learn more about our webinar, please click here.
development and manufacturing capabilities in response to growing biomanufacturing demands. The Company also said that it is in negotiations with the authorities at IFEZ (Incheon Free Economic Zone) to purchase additional land for its second bio complex.Upon finalization of the terms under negotiation, the total size of the two investments is expected to be over 2 trillion Korean won—roughly equivalent to 2 billion US dollars—and over the total amount invested in the Company’s previous three plants combined throughout its nine-year history.Adding 256KL capacity to its site, Plant 4 is scheduled to commence manufacturing activities in the second half of 2022, and further advance the company’s standing as the world’s largest manufacturing facility at a single location—holding a 620KL total capacity upon completion. Samsung Biologics is taking an innovative approach in the design strategy of its new plant: by incorporating the unique advantages from Plant 1, 2, and 3, it will offer multi-scale manufacturing services to support the diversifying needs of new and existing clients.Construction will begin on an existing site with the plant comprising of 238,000 square meters in total floor area - the equivalent to the combined floor area of its existing three plants. In an effort to maximize operational efficiency, Plant 4 will introduce real-time production schedule simulation through automation and latest biomanufacturing technologies as well as optimization of utility supply based on data collected from its current plants.Samsung Biologics is also investing heavily in offsetting its facilities’ environmental impact. Newly advanced technologies such as streamlined application, smart disposal of high-concentration wastewater, and improvement of nitric acid emissions will strengthen the environment of the workplace and community.The land under negotiation for Samsung Biologics’ second bio complex is closely located to the Company’s current complex, and is slightly larger at 330,000 square meters. Once the terms are finalized, the Company plans to create an Open Innovation center to foster biotech companies and build a global R&D facility in addition to securing space for future plants within the new complex.“In this continuously evolving climate, we are strategically positioning ourselves to respond to the needs of our global clients who are producing new medicines that are more complex and diverse, and deliver superior client satisfaction,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “With the production of Plant 4, our ‘Super Plant,’ Samsung Biologics is investing in a total line refinement and addition of new mid- and small-scale facilities to ensure production efficiency and provide top-notch services to raise the bar even further to establish ourselves as the leading global standard.”Owing to its quality competitiveness, state-of-the-art technology, and active response to demand for outsourced manufacturing of products including COVID-19 treatment candidates, Samsung Biologics has signed over 1.8 trillion Korean won in orders, about 2.5 times last year’s total revenue, in the first half of 2020 alone.
development timeline by a month from the industry average of four to five months. The company will also provide attractive payment terms for clients choosing to use this cell line technology for their future development. Leveraging these combination of advantages, Samsung Biologics recently signed a development contract with a client under which S-CHOice will be used to advance its cell line development. “We are extremely proud to announce the official launch of our own proprietary cell line, S-CHOice,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “With this advanced, high performance technology, we can now offer our CDO clients with even more promising options in bringing their molecule faster and better to the market and ensure world-class client satisfaction during this continuously evolving global climate.”
development and manufacturing contracts valued approximately at KRW 1.8 trillion in the first half of this year alone, which is about 2.5 times higher than last year’s total annual revenue.Samsung Biologics entered into its largest contract manufacturing agreement with Vir Biotechnology, valued at KRW 440 billion, for a potential COVID-19 treatment, and signed a KRW 280 billion CMO contract with GSK in May to expand its innovative biopharmaceutical portfolio.“We have adjusted to operating in a more virtual environment due to COVID-19 and the profound changes it introduced,” said Tae Han Kim, CEO of Samsung Biologics. “Our Live Virtual Tour and Virtual Exhibition Hall are investments in innovative technology that allow us to communicate and serve our clients and regulatory authorities, while also keeping their safety in mind. In this global crisis, we will continue to raise the bar in strengthening our cost competitiveness and agility for maximum client satisfaction to be a one-stop service provider that is relentless in its pursuit of innovation.”As operations are expected to reach full capacity by 2022, Samsung Biologics is looking into adding a fourth plant and new bio campus to fulfill the growing biopharmaceutical market needs. Additional details will be released once the facility design, schedule, and investment plans are finalized.
development, process development, non-clinical and clinical material manufacturing, to IND submission support for global clinical trials of five candidates from ImmuneOncia’s pipelines.ImmuneOncia’s portfolio comprises diverse immune checkpoint antibodies including IMC-002, a CD47-targeting antibody that is currently undergoing a global phase 1 study based on the successful IND-filing approval obtained through the development and manufacturing partnership with Samsung Biologics.“Our CDO mission is to enable biotech companies to focus on discovery by providing faster and better development and manufacturing services,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “We are extremely proud to expand our partnership with ImmuneOncia and assist in their endeavor to bring new treatments such as IMC-002 for cancer patients.”
development and manufacturing service agreement of STM418, an anti-PD1 immuno-oncology candidate. STM418 received much attention from the biopharma industry earlier this year upon publication in the Cancer Research Journal. Through preliminary studies, STCube reported that STM418, which selectively masks glycosylation site N58 on PD-1, potently inhibits PD-1/PD-L1 binding to enhance anti-tumor immunity. Under the development and manufacturing agreement, Samsung Biologics will offer full scope of CDO services from cell line development, process development, non-clinical & clinical material manufacturing, to IND submission for global clinical trials of STM418. “We look forward to getting fast IND approval for our novel PD-1 antibody through this extended partnership with Samsung Biologics, a world-class CDMO," said Hyun-jin Jung, CEO of STCube. "We will commence global clinical trials to prove the enhanced efficacy compared to existing PD-1 antibodies.” Samsung Biologics CDO business has been growing at a tremendous pace since its launch in 2018 with a high number – over 50% – of clients returning for additional business collaboration. STCube, another returning client, had entered into its first CDO partnership with Samsung Biologics in March this year for an immuno-oncology molecule, STT-003. “We are grateful to STCube for this extended partnership and for recognizing our development expertise and our dedication to bringing client products to market faster and better,” said Dr. Tae Han Kim, CEO of Samsung Biologics.
Development Richard Lee Head of Drug Product Business Unit Dan Slone Vp & Head of Downstream Manufacturing John Gill Director, Cell Line Development Justin Carbungco Associate Director, sCMO Operations BIO 2020 Encore brings back our speaker series at BioProcess International Theatre, which will be held from 8th~9th of July. The conference will hold discussions on two main topics: Emerging Therapies and Emerging Techniques, Technologies, and Strategies. There are 5 speakers from Samsung Biologics participating this year at five different sessions. Justin Carbungco, Associate Director of Small Scale Manufacturing will discuss studies on "Economics of Stainless Steel and Single-Use Systems" on July 8th at 3:15pm. At 4:15pm, John Gill, Director of Cell Line Development will talk about "Accelerated & High Performance Cell Line Development". On July 9th at 2:30pm, Richard Lee, Head of Drug Product Business Unit will share studies on "Securing Your Manufacturing Capacity During the Pandemic". For the on-demand sessions, Daniel Slone, VP & Head of Downstream Manufacturing joins in as the panel to discuss on "The Evolving Role of the Outsourcing Manufacturer: Why CDMO Is the New Normal". Also Kevin Sharp, Director Business Development sits down with Bioprocess Insider editor to discuss Samsung Biologics' response to the COVID-19 pandemic. To learn more about our sessions, visit here.
Development · Speaker : John Gill· Date : July 8, 16:15 - 16:35 pm · Title : Economics of Stainless Steel and Single-Use Systems · Speaker : Justin Carbungco· Date : July 8, 15:15 - 15:35 pm · Title : Securing Your Manufacturing Capacity During the Pandemic · Speaker : Richard Lee· Date : July 9, 14:30 - 14:50 pm · Title : Roundtable: The evolving role of the outsourcing manufacturer: Why CDMO is the new normal· Speaker : Dan Slone· Date : On-demand · Title : Insider Interview: How Samsung Biologics is expanding its capabilities & improving business resilience in COVID-19· Speaker : Kevin Sharp· Date : On-demand
Development · Speaker : John Gill · Date : 9/21 (12:00~12:20 pm, EST) · Venue: Online · Title : Fast & Efficient Downstream Process Development with Two-step Purification Platform · Speaker : Beomkyu Kim · Date : 9/23 (3:20~3:40 pm, EST) · Venue: Online · Title : A development strategy for identificaation and improvement of lactate metabolism variations · Speaker : VP Yongho Ahn · Date : 9/23 (3:40~4:00 pm, EST) · Venue: Online
development strategy for identification and improvement of lactate metabolism variations · Speaker : Yongho Ahn (VP) · Date : August 25, 12:25 - 12:45 pm · Title : Fast & Efficient downstream process development with two-step purification platform· Speaker : Beomkyu Kim · Date : August 26, 11:25 - 11:45 am · Title : S-CHOice, Accelerated High-performing Cell Line · Speaker : John Gill · Date : August 27, 1:15 - 1:35 pm
development and manufacture of biologics that have the potential to address significant unmet medical needs, such as COVID-19 therapies. Timelines for a successful tech transfer are often determined by a variety of factors, including requirements and timelines for analytical development, equipment availability and raw materials. This technical note describes how Samsung Biologics have successfully developed a number of innovative strategies as part of a tech transfer plan to support faster biologics development and manufacturing programs.
development. This presentation is to share Samsung Biologics’ successful implementation of N-1 perfusion process to large scale and the key consideration factors for perfusion process development & Large-scale optimization, particularly focusing on design, installation, operation, and process simulation.
파일 다운로드를 위해 뉴스레터 구독용 이메일 주소를 입력해주세요.
* 구독자라면 구독중인 이메일 주소를 입력해주세요.
뉴스레터 구독 서비스를 등록하시면 당사 뉴스룸에서 제공되는
삼성바이오로직스의 최신 소식과 관심 분야별 유용한 정보를 받아 보실 수 있습니다.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.
Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Target Anticancer Drugmore
-Naming Biopharmaceutical Products 1 Monoclonal Antibody Drugsmore
-Naming Biopharmaceutical Products 1 Monoclonal Antibody Drugsmore
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Target Agreement for Novel Targetmore
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Targetmore