SERACH RESULTS FOR" Manufacturing "
manufacturing process, beta-glucan impurities can lead to batch recalls and other quality issues. In this whitepaper, Soonbin Kwon, our Senior Scientist in MSAT, explores the source of the beta-glucan impurity, its influence on manufacturing and patient safety, and strategies to detect and control its amounts in the final drug product.
manufacturing organization, today
announced strong financial results for the first quarter of fiscal year 2022. John Rim, CEO of Samsung Biologics, stated, “Samsung
Biologics’ strong start to the 2022 fiscal year was driven by building momentum
around our long-term growth strategy and expanding capacity. Our first-quarter
financial performance demonstrates a significant and sustained level of
customer demand in our services and capabilities. Turning to the present and
future, Samsung Biologics has also committed to making sustainability a key
component of the way we work and engage with our partners and communities. In
our mission to build a healthier future for all while creating enduring and
sustainable value, we are investing in initiatives to mitigate the risks of
climate change in the greater areas we impact.” FIRST QUARTER 2022 RESULTS Samsung Biologics demonstrated strong operational excellence
and business agility in the first quarter with earnings exceeding initial
projections. First quarter 2022 revenue was KRW 511.3 billion, an
increase of 96% from KRW 260.8 billion reported for the first quarter in the
previous year, attributable to the expansion of product sales and the
increasing exchange rates amid stable operations of Plants 1, 2, and 3. First quarter 2022 operating profit was KRW 176.4 billion, 137%
higher than the prior-year period due to steady sales growth and an increase in
the operating rate at Plant 3. First quarter 2022 net profit reached KRW 146.9 billion, an
increase of KRW 85.9 billion from KRW 61.0 billion in the first quarter a year
ago, and first quarter 2022 operating margin was 35%. [KRW billion]
FISCAL YEAR 2022
manufacturing services. The company is currently building Plant 4, which will partially become operational in October 2022. In addition, Samsung Biologics 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 for future growth.
manufacturing and development process, and it seems there’s a lot of responsibility involved in your role.We always prepare for a project from the start and work meticulously because one simple mistake can cause a ripple effect and lead to quality issues at large. Responsibility is an essential factor as biomedicines we produce are directly making an impact on human life.There must be a ‘continuous learning’ factor to your role since it’s related to improvement.That's right. I’m working in an environment where I’m constantly exposed to learning. We help other groups within the Quality Center to become more efficient, so we need to understand what's going on from start to finish. By collaborating with IT, I'm trying to figure out how to digitize our processes and capabilities more effectively to achieve quality innovation. To shift to your background for a second - I heard that when you were deciding between going to graduate school and getting a job, the internship at Samsung Biologics influenced your choice.Yes, during the summer of 2017, I was debating between going to grad school or going straight into work. Then I got the opportunity to intern at Samsung Biologics. Even though it was for only two months, I had such a memorable experience and the best thing was that I could actively express my opinions and get insights while working with experts in the bio industry. That kind of experience was unforgettable.What was your experience joining later as a full-time employee?After my internship, I saw how much Samsung Biologics values work-life balance and developing a positive company culture and I thought I could continue to learn and grow here.During my third year at Samsung Biologics, I got the chance to present my project at an executive meeting. At that time, I felt a lot of pressure, but thanks to the help and advice of my colleagues, I was able to deliver a successful presentation. Looking back, I think this was a stepping stone for growth. It's already been 5 years since you joined the company. How do you think you will grow in the next 5 years?I think 'growth' is a result that only comes to those who constantly make an effort. I want to be a person who always has an end goal in mind. Based on my new experiences and broadened perspective from meeting new people at work, I realized that I want to be able to help someone later down the line, similar to the mentorship I’m receiving now. What efforts are you making to gain diverse perspectives and experiences?The expression "Think outside the box." comes to mind first. As my work requires collaboration with various departments, learning and understanding new things is essential. Through continuous communication with departments, I’m learning about trends in the industry, while trying to broaden my horizons by leaning into various perspectives. The biopharmaceutical industry is known to be quite conservative, especially in adapting new IT technology. However, at Samsung Biologics, thanks to the Digital Transformation initiatives driven by our IT teams, we are leading several new digital innovations in the quality process, which is really exciting. One question we always like to ask our fellow colleagues is what are you driven for?I’m driven for my family because they always support me in times through the good and bad times. In 2021, Samsung Biologics was contracted to manufacture Modena's COVID-19 vaccine drug product, and my family and friends were very curious about the news. There were a lot of questions like ‘When is it coming out?’ and ‘Can I get it in Korea?’ This was the moment when I realized the greater impact of what I do at Samsung Biologics. I was proud that I was able to help my family and the other important people in my life. Samsung Biologics celebrates the unique qualities, perspectives, and experiences that define us as individuals. Whether you're a hard-worker, smart thinker, dreamer or doer, we share one goal at Samsung Biologics: we are all driven
manufacturing continues to grow, so too does the importance of engaging CDMO partners who harness the right capabilities and expertise to ensure product stability and patient safety. In this whitepaper, John Thomas, Director of Drug Product MSAT, details how Samsung Biologics’ dedicated and experienced DP MSAT team provides end-to-end F/F services, while maintaining business continuity and insulating clients against supply shortages.
manufacturing organization (CDMO), hosted its 11th Annual General Meeting of Shareholders (AGM) today. Five matters were presented and approved unanimously at this year’s meeting, which included the approval of financial statement, appointment of directors, appointment of director as audit committee member, appointment of audit committee member, and approval of the remuneration limit for the directors. “As part of our vision, we are now venturing into the three core pillars of our multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint,” said John Rim, CEO of Samsung Biologics in an address to the shareholders. “As a leading CDMO service provider, we will continue to demonstrate our excellent business operations throughout our value chains to ultimately contribute to saving the lives of patients and build a better future for all.” Same as last year, Samsung Biologics implemented an electronic voting system, and the meeting was made available for virtual participation via a live broadcast. Due to the ongoing COVID-19 pandemic, the company took precautionary measures throughout the meeting to ensure the health and safety of all attendees. Samsung Biologics’ Plant 4 is currently under stable construction to begin operations by the end of this year, and the company is steadily securing pre-sales with clients. Upon the full completion of Plant 4 in 2023, the company is expected to hold the world’s largest biomanufacturing capacity. The company is further looking into securing additional sites within Songdo for its second bio campus, and also overseas in multiple locations to expand its business in closer proximity to its global clients. For more details of the 2022 AGM, please see the reference material available under the following link.
manufacturing capacity, we continue to focus on providing useful corporate information to our clients and investors around the world. We will do our best in being a highly trusted company by demonstrating transparency and robust governance throughout our business activities,” said John Rim, CEO of Samsung Biologics.
manufacturing, and testing services, all from a single location. We now provide CMO services for advanced biomedicine of global pharmaceuticals and CDO services for cell line and process development. Also, we established a branch in San Francisco, US, for stable expansion for CDO business. Samsung Biologics’ Plant 4, the world’s largest biopharmaceutical manufacturing facility, is currently under stable construction and will commence partial operations in Q4 this year. Samsung Biologics will be a global healthcare company providing end-to-end services. ■ Description- Internship Period: 6/27(Mon)~8/5(Fri), total 6 weeks (2 weeks online + 4 weeks onsite) *Plans are subject to change- Location: Samsung Biologics – Songdo Bio Campus, Incheon, Korea - 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 apply1) Application Submission and Essays (~2/28(Mon) 17:00, KST)- Submit your online application form via https://forms.gle/H4wPFgHAnqcsAhPo7- Essay form is going to be announced to your email that you submitted. - Please be informed that after you submit the online application form, you have to write the essays within the application period.- We encourage you to apply as soon as you are ready 2) Video Interviews- Selected candidates from the application screening process will be invited to attend our Video Interview (via Zoom) 3) Final Result Announcement 4) Internship period: 6/27(Mon)~8/5(Fri), total 6 weeks (2 weeks online + 4 weeks onsite) *Plans are subject to change ■ Internship BenefitsIn addition to the exciting hands-on experience, Samsung Biologics will offer an internship stipend, daily transportation, accommodations (if necessary), free meals, and etc. ■ Contact UsFor any inquiries, please contact email@example.com or +32-455-3738/9750 Related Contents Our Story | Create New Possibilities with Samsung Biologics - Stories From Our 2021 Summer Interns
Manufacturing Technology Intern(Major in Biochemical Engineering, University of Illinois at Urbana-Campaign) If I could sum up in one word my internship at Samsung Biologics, it would be ‘RESPONSIBILITY’. I felt a sense of duty to the work I did and it inspired me to want to continue exploring the difference in cell culture growth between small scale run versus large scale. Sung-Dae Kim | USP Group, Manufacturing Technology Intern(Major in Biochemical Engineering, University of Illinois at Urbana-Campaign) My goal is to become a leading contributor and innovator in the pharmaceutical industry to bring a positive influence to the world. I would say my internship was very ‘ADVENTUROUS’ Every single day at Samsung Biologics fueled my passion for exploration and creating bold ideas. Ye-Jin Kim | Site GMP Compliance, Quality Operations Intern(Major in Chemistry, University of Illinois at Urbana-Campaign) Together, we can make a better life and better future.Driven. For Life. Related ContentsCareers Roles in Samsung BiologicsYouTube Samsung Biologics Internship: Most Memorable Experiences YouTube A Day in The Life of a Samsung Biologics Intern
manufacturing organization (CDMO), announced that it has been selected as a winner of the 2022 CMO Leadership Awards presented by Outsourced Pharma and Life Science Leader. Samsung Biologics received a total of six CMO Leadership Awards across all performance categories: capabilities, compatibility, expertise, reliability, quality, and service. Now in its 11th year, the CMO Leadership Awards offer accurate and reliable customer feedback to provide support in choosing a reputable partner for development and manufacturing needs within the biopharmaceutical and pharmaceutical industry. Since 2013, Samsung Biologics has been recognized in the CMO Leadership Awards for nine consecutive years. “We are incredibly proud to receive this distinction across all six performance categories, especially at this pivotal moment in healthcare when it is more crucial than ever to successfully supply medicines to our clients and save the lives of patients,” said John Rim, President and CEO of Samsung Biologics. “This recognition reminds us of our responsibility as a trusted CDMO partner to our clients and to respond quickly to the evolving needs in the industry.” “For nearly a decade, these awards have proven most meaningful for biopharma organizations striving to obtain optimal outcomes from their outsourcing activities,” said Louis Garguilo, Chief Editor and Conference Chair of Outsourced Pharma. “Our research arm, Industry Standard Research (ISR), which only surveys drug sponsors who have worked recently with specific CDMOs, ensures the validity of these results. Our winners will be your champions of outsourcing.” Samsung Biologics demonstrated strong operational performance and business agility in 2021 with all Plants 1, 2, and 3 in stable operations. Plant 4 will commence partial operations in Q4 this year with full completion expected mid-next year, and the company will also begin construction of Plant 5 within 2022 where it will offer multi-modal product services in addition to the mRNA vaccine drug substance (DS) manufacturing suite expected to be ready for cGMP operations within the earlier part of this year. About the CMO Leadership AwardsNow in its 11th year, Outsourced Pharma and Life Science Leader’s CMO Leadership Awards provide readers with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs. For the 2022 CMO Leadership Awards, Industry Standard Research (ISR) determined the award recipients through their evaluation of more than 86 contract manufacturers. These CMOs were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. For more information about the awards, visit the awards website.
manufacturing 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.
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
manufacturing capacity, continued advancements in business portfolio, and greater global footprint. With the company aims to evolve as the top biopharmaceutical company, Rim outlined the key growth drivers for 2022 and here are some of the key highlights from the presentation. Key achievements of 2021 *Multi-Modal Plant *Korea Corporate Governance Service*Dow Jones Sustainability ‘World’ Index*Sustainable Market Initiative Business goals and vision for 2022 1) Expanded manufacturing capacity ● Plant 4 partially operational (Q4 2022) ● Secure additional sites within Songdo for Bio Campus II 2) Advancements in business portfolio ● Successfully process mRNA DS cGMP Ready (Q2 2022)● Groundbreaking of Plant 5, which will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site ● Establish plans for Open Innovation Center 3) Greater global footprint ● Expand overseas, additionally to San Francisco R&D Center Related contents Press Release Samsung Biologics Shares Strategic Roadmap for Sustainable Growth at the 40th Annual JP Morgan Healthcare ConferenceNews Brief JP Morgan Healthcare Conference (Audio Link)YouTube The Future of BioPharma: Plant 4ESG Sustainability Report 2021
manufacturing capacity, continued advancements in business portfolio, and greater global footprint. “For Samsung Biologics, 2022 will be a year where we will be able to take a great leap forward for sustainable growth and endeavor to maximize our capabilities as a leading CDMO,” said John Rim, CEO of Samsung Biologics during his presentation at the conference. “Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities in overseas, Samsung Biologics will be able to accelerate the build-up of its core success drivers as the next growth engine of the industry.” As part of its growth plan, Samsung Biologics is planning to start the construction of a new facility, Plant 5 this year where it will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site. This will be additional to the mRNA vaccine drug substance (DS) manufacturing suite the company is currently adding to its existing facility in Songdo, which is expected to be ready for cGMP operations within the earlier part of this year. The company is further venturing into securing additional sites within Songdo for the construction of Plant 6 and Open Innovation Center, and also overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in close proximity to its global clients. Samsung Biologics’ Plant 4 is currently under stable construction to be partially operational by the end of this year and the company is steadily securing pre-sales of clients. Upon the full completion of Plant 4 in 2023, the company is expected to hold a total of 620,000L of capacity, reaffirming its position as the world’s largest CDMO. Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with all Plants 1, 2, and 3 in stable operations, marking record-high financial results in two consecutive quarters. The company successfully laid a robust foundation in the mRNA business area through signing strategic partnership agreements 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 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.
manufacturing agreement and successfully obtained Marketing Authorization from Ministry of Food and Drug Safety of Korea within 7 months of signing.In November, we also announced the collaboration to manufacture GreenLight’s mRNA COVID-19 vaccine candidate at commercial scale, aiming to open the way to make vaccines available to everybody, including patients in lower income countries. With our commitment to save lives by creating greater accessibility to biomedicines worldwide, this year we made an announcement 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.
manufacturing processes to be able to respond to market demand more quickly. He continues to grow and diversify the company’s business portfolio through expansions including the building of the mRNA drug substance manufacturing suite, and the construction of the company’s fourth plant known as the ‘Super Plant’. Upon completion of the ‘Super Plant’ in 2023, Samsung Biologics will hold 620,000L of total manufacturing capacity, responsible for approximately a quarter of the entire global biopharmaceutical contract manufacturing capacity.
manufacturing COVID-19 vaccines and treatments, the pharmaceutical industry in particular has had to rapidly overcome supply chain challenges concurrent with heightened demand. David King, our Director of Drug Product Operations discusses how CDMO partners and drug developers have embraced multi-sourcing strategy to ensure uninterrupted manufacturing and mitigate supply risks.
manufacturing and 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
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.
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.
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.
manufacturing capacity of 620,000L at a single site. We also opened up a global R&D Center in South San Francisco at the heart of the fastest developing biocluster to provide immediate convenience to global clients. Additionally, we launched our proprietary cell line S-CHOice® and process 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
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."
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.
manufacturing capacity of 620,000L', 'S-CellerateTM (CDO process platform to expedite timeline to IND and BLA)', and 'Multi-modality expansion'. James Choi, Senior Vice President and Chief Information and Marketing Officer, Head of Investor Relations said, “A large number of people came to visit us at our booth despite the ongoing pandemic and it was great to be back to connect with the clients and industry leaders in person. I believe the event zone and VR zone provided special and memorable experience to the visitors, and there were also great deal of active engagement and business discussions. Doing so, we showcased our fully integrated, end-to-end services of CDO, CMO, and biosafety testing services with top-notch quality which will help our clients to bring their life-saving drugs to the patients." “Samsung Biologics' booth was designed to highlight its core brand identity that was newly established earlier this year. To better conduct meetings with clients and industry stakeholders, we provided three meeting rooms and an open lounge area for us to network and connect more efficiently. Also, most importantly, we took precautionary measures in regards to COVID-19 before and after meetings to ensure the safety of both our employees and visitors during the event," added Dahyun, a Senior Specialist on the Digital Marketing Team. Serving the needs of clients in person, in real-timeSamsung Biologics hosted active in-person meetings and explored various business opportunities with potential clients who were seeking 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 glo
manufacturing capacity of 620,000L', 'S-Cellerate (CDO process platform to expedite timeline to IND and BLA)', 'Multi-modality for business portfolio expansion', and 'Offering of end-to-end, one-stop service'. Samsung Biologics will follow the guidelines to help prevent the spread of COVID-19 and advise all attendees to be wearing masks when visiting the booth.
manufacturing industry’s race for expansion, few companies are as equipped for the sprint like Samsung Biologics. Since it was established in 2011 and in short order became a CDMO force, Samsung has sought to do everything quickly. A conversation with CEO John Rim has a consistent theme—speed. Read More All rights are reserved by the media that published this article.
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 taking place with
manufacturing process. In this whitepaper, Calvin Kim, our Head of IT Quality Systems and Validation, discusses various controls required to tackle DI-related challenges and to create a holistic framework of data-driven governance. As a CDMO service provider, Samsung Biologics strives to set an industry-leading standard in DI practices, supported by innovative technology, conscientious corporate policy, and efficient quality systems for consistent delivery of products and services.
manufacturing and production process, materials sourcing is crucial in delivering the highest quality of raw materials without delay, and nobody is more familiar with the intricacies of it than Yongkwan Ma. As a senior buyer on our procurement team, Yongkwan not only purchases the raw materials, but he also identifies and mitigates supply risks due to unforeseen circumstances, like in the case of the COVID-19 pandemic. Hear how he sees Samsung Biologics evolving its supply chain capabilities in the future and why “Driven. For Life” is meaningful reminder of his social responsibility to the health of society. What are your job responsibilities at Samsung Biologics?I purchase raw materials, like media, resin and chemicals, so that we can use them to make the final products. Planning this purchase requires an attention to detail, such as how much we need, by when, and with what kind of manufacturing [taking into consideration the expiration date]. This needs to be communicated with the vendor on a daily basis, otherwise there’s the possibility of a shortage or excess inventory.Beyond that, my role is also to be a first responder if there is a supply risk caused by market change for specific items or unexpected circumstances such as what happened with the COVID pandemic. We acknowledge that most of us are going through exceptional supply constraints recently due to not only the COVID pandemic, but also because the pharmaceutical market is expanding more rapidly than expected. Therefore, as a supply chain manager, I ensure that all stakeholders are aware of these risks early on and provide possible scenarios to resolve any problems that arise. Can you please briefly explain the role of materials sourcing in the pharmaceutical supply chain?As a manufacturing company for biomedical products, we certainly keep our focus on bringing about a better life for all humanity at the forefront, so it is vital to provide our product stably with perfect quality for our clients and also for the patients who need the product. Our manufacturing ability along with the process of quality control is the key to achieving the perfect quality product. But it also would not be possible to achieve this without having quality raw materials. So, it is our goal to manage and source suppliers that meet our quality requirements, while enabling the stable supply of the raw materials in time. How has the Supply Chain Management team at Samsung Biologics been managing supply chain since the start of the COVID-19 pandemic?Most of the biopharmaceutical companies including Samsung Biologics have been challenged with supply constraints for raw materials. This is simply because most of the raw materials have been prioritized for the COVID vaccine or COVID-related treatment, which has led to an extreme increase in market demand while suppliers’ manufacturing capacities are limited.So, in order to take steps to remedy the situation, we first set up a Supply Chain Management (SCM) task force early last year with relevant departments. This allowed us to make an efficient organizational system and decision-making process as well as prepare Risk Management assessments through our Business Continuity Management System to be able to take timely actions against last-minute changes in the supply plan.Furthermore, to hedge our risk we took various actions including multi-sourcing, changing safety stock strategy, categorizing items based on supply stability, and establishing close partnerships with key suppliers, clients and the government. I believe that all of these activities are allowing us to manage stable production without any critical raw material issues so far. What trends in Supply Chain Management (SCM) do you see forming in the post COVID-19 era, and how do these connect to our company’s long-term strategies?I am quite certain that there will be dramatic changes in the post COVID-19 era. Especially in the biopharmaceutical industry, it takes a long time to develop
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."
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.
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."
manufacturing to the point of administration. In his work on the product export side of the supply chain, Changgeun Lee, a Senior Specialist in Logistics, helps evaluate our cold chain capabilities, while guaranteeing that critical healthcare products, like the COVID-19 vaccine, are delivered at the right temperature, at the right time. Hear from Changgeun about how our cold chain solutions offer clients a tightly managed, high-quality storage and distribution process to preserve the integrity of these critical biopharmaceutical products. What are your job responsibilities at Samsung Biologics?My main job responsibilities include communicating and coordinating with clients to ship products to client-designated external sites, executing validation for cold and frozen storage and cold chain shipping validation, generating GMP pack-out and ship-out procedures based on validation results, and finally maintaining and storing products in proper temperature-controlled storage. Can you please briefly explain what cold chain storage is? Why is it so important in the supply chain distribution and management process?Cold chain is a temperature-controlled supply chain, ensuring proper storage and transportation of temperature sensitive items. Cold chain is especially important in the pharmaceutical industry, since temperature excursion might directly impact product quality. Because distribution is the final step of the entire supply chain, it is crucial that the product is kept at a specified temperature range during storage and transportation. What services and capabilities does Samsung Biologics offer in regards to cold chain logistics?Samsung Biologics has extensive experience in cold chain shipments from client tech transfer to our own validated methods. Alongside a 24/7-monitoring system, we maintain cold and frozen storage under proper temperature conditions from ambient to -70 degree Celsius. All of our storage and cold chain activities meet regulatory compliance criteria, and are managed by highly trained experts. What challenges does the industry face with the new mRNA vaccine technology, and how can Samsung Biologics’ unique capabilities help to solve those problems?Most of the new mRNA vaccines are temperature sensitive and lack stability data, so it is critical that they be stored at ultra-cold or frozen conditions. Samsung Biologics has the capabilities and experience to support and respond to these types of cold chain challenges that the industry is facing.From cold to frozen conditions or from passive to active containers, we have experience in pack-out and ship-out for almost every cold chain activity. This extensive knowledge allows us to expedite the cold chain implementation process and provide additional solutions to our clients.We’ve also supported clients with numerous cold chain shipments including shipping validation, and in certain cases, provided our own shipping solutions. [What sets us apart is that] We’re continuously investing in expanding cold and frozen storage solutions to respond to the industry’s needs.
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.
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
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.
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.
manufacturing of Moderna’s COVID-19 vaccine.Recently, John Rim, CEO of Samsung Biologics, had an interview with Thomas Byrne, President and CEO of The Korea Society, a nonprofit organization that aims to promote greater awareness, mutual understanding, and cooperation between the U.S. and South Korea. The Korea Society’s “President's Interview Series” particularly explores the economic, financial, and business relations between South Korea and the U.S. In addition to sharing the current outlook of the pharmaceutical industry, CEO John Rim discussed Samsung Biologics' capabilities to manufacture mRNA vaccines, its role in the ongoing pandemic as a leading global CDMO, and its future growth vision. To watch the full interview, please click on the video below. If you want to read about Samsung Biologics’ COVID-19 vaccine agreement with Moderna and our plans to add mRNA vaccine DS production capability to its facilities, please visit our Newsroom for more information.
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.
manufacturing of billions of doses for COVID vaccines and treatments, the pharma industry in particular has been tackling heightened demands in collaboration with stakeholders in the value chain. From both the drug developers’ and suppliers’ perspectives, a multi-sourcing strategy has been essential to ensure continuous production and to meet these increased demands and associated threats. In this session, you will learn how Samsung Biologics has been working closely with our clients and regulatory agencies to guarantee a resilient supply of raw materials and deliver pharmaceutical medicines on time through a multi-sourcing strategy.
manufacturing is driven by agile, efficient production scale-up and consistent, high product quality. To achieve this, process characterization is critical to the commercialization of new biopharmaceuticals since it ensures not only quality and efficacy, but also patient safety. In this whitepaper, Thomas Gervais, our head of Manufacturing Science and Technology, examines how we combine scaled-up manufacturing data with small-scale understanding to maximize clients' production cadence.
Manufacturing Support Systems, Seongil Cho and his team implement and support enterprise IT systems, including those related to virtual inspections. Samsung Biologics conducts many client and regulatory authority inspections per year; however, on-site inspections and tours became difficult to conduct during the pandemic. To solve this challenge, Seongil and his team implemented the Live Virtual Tour (LVT) solution 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 from any location. In this interview, Seongil shares with us how the IT team has successfully utilized LVT, insights on future IT trends, and what “Driven. For Life.” means to him. Can you please briefly explain what Live Virtual Tour is and some of its unique features, and why we developed it?Live Virtual Tour is similar to other virtual conferencing systems, but it has a higher quality and resolution to give clients the feeling as if they are ‘teleporting’ to our site. Because of the travel restrictions amid the pandemic, our clients and regulatory bodies like the FDA and EMA couldn’t visit our site to do regular audits and inspections. So we decided to develop and implement a digital platform, such as Live Virtual Tour, to support the auditing process. A real-time video conferencing system is a necessary part of remote auditing in the pandemic, but many of the popular web conferencing applications did not provide good enough quality. That’s why we eventually made our own live virtual system. Since its launch last year, what are some of the successful ways we’ve utilized the platform?Live Virtual Tour has since been successfully utilized in over 50 virtual audits and inspections. Our most successful story was participating in one of the FDA’s earliest virtual inspections. Most recently, we also performed a virtual inspection with the EMA and received six Pre-Approval Inspections (PAI) over the course of seven days with no critical observations. We are finding better ways to improve the quality and technology of this proactive solution and will continue to improve it and provide customized access to our potential and existing clients as well as regulatory authorities. How will Samsung Biologics leverage Live Virtual Tour after the pandemic ends?Regardless of the pandemic, LVT is being used as a complete remote tool in solving equipment problems, which is also a great way to ensure hygienic site protection from a cost and quality perspective. I believe the global trend of remote auditing will continue and we will move forward with more innovative 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
manufacturing activities to ‘contract manufacturing organization (CMO)’ partners like Samsung Biologics to get their products to market with speed, quality and in the most cost effective way possible. In this article, we will explore the services a CMO can provide and the benefits the right partner can bring to projects. We will also showcase Samsung Biologics’ unique strengths and capabilities as one of the world leading CMOs with the world’s largest manufacturing capacity on one single site. What does a CMO Offer its Clients and What are the Benefits? To ensure the successful delivery of biomedicines a biopharmaceutical company must be fully equipped with the right capabilities and available capacity to manufacture products at any scale and, be able to accommodate the evolving needs in the market. In order to deliver proven-quality biomedicines to patients, a CMO must be able to strictly control quality across its facilities and its manufacturing processes according to GMP (Good Manufacturing Practice) standards. (*Please refer to the article “What are Biomedicines” for more information.) With these complex requirements, bringing products to the market safely and on time can be a challenging process. This combined with the surging demand for biopharmaceuticals means that companies are looking for outsourcing partners who can manufacture their products with speed, flexibility, and up-to-date technology. Successful outsourcing can allow them to focus their internal efforts on research and discovery of new treatments, while ensuring 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 manuf
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.
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.”
manufacturing of mRNA vaccines, and also shared the company’s vision and long-term plans to better serve existing and potential clients. EXCERPTS FROM CEO JOHN RIM’S KEYNOTE SPEECH > “Standing alongside our partners, Samsung Biologics is extremely honored and proud to be able to contribute in this battle against COVID-19. As most recently announced, we are fully committed to leveraging our experience in manufacturing technologies to support the aseptic fill and finish of Moderna’s mRNA-1273 vaccine with quality, speed, and efficiency to aid in the fight against this global crisis.” > “With our leadership in contract manufacturing, Samsung Biologics has set out to become a true end-to-end biologic solution provider with seamless integration with contract 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 introducin
manufacturing technologies to support the aseptic fill and finish of Moderna’s mRNA-1273 vaccine with quality, speed, and efficiency to aid in the fight against this global crisis,” Rim said. “We will be also adding a dedicated production suite for mRNA bulk drug substance to our existing facility by the first half of 2022, which will enable us to rapidly manufacture and supply future vaccines and treatments against multiple targets.”Joon Chang, Senior Director of Global Sales and Operations Center will be presenting during a fireside chat on June 16th at 3PM (EDT) on the emerging trends of CDMO industry and its partnership highlighting the unique values that Samsung Biologics delivers to clients. Also this week, Sam MacHour, Senior Vice President & Chief Quality Officer, joined Dan Stanton 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 future plans for the CDMO space and beyond. In response to an increasing worldwide demand for biopharmaceuticals, Samsung Biologics has been taking preemptive approaches to actively accommodate the evolving needs of the industry through continuous innovation and investments including the addition of its fourth and largest plant, San Francisco R&D Center, and mRNA vaccine drug substance manufacturing and filling capabilities. Visit here to join us at BIO Digital 2021 and find the right solution with us for your success. (https://www.bio.org/events/bio-digital)
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.
manufacturing services from bulk drug substance to aseptic fill/finish including labeling & packaging, as well as cold chain storage. Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing end-to-end contract 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.
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.”
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 ‘products’ here
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.”
Manufacturing Sciences and Technology, discusses key considerations and challenges in implementing N-1 perfusion technology as well as the impact of continuous technology on tech transfer and process scale-up. The presentation includes: - Impact of continuous technology on tech transfer and process scale-up- Key considerations and challenges in N-1 perfusion to meet reduced cell culture duration and higher protein titers in the overall product yield- Real case: Before vs After implementing N-1 technology- Preparing for next plan for continuous process intensification
manufacturing process to start off on the right foot. As a trusted CDMO partner, Samsung Biologics drives its clients’ 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.
manufacturing and 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 interna
manufacturing facilities remain fully operational, without any disruptions caused by the COVID-19 pandemic.- Construction for the new Plant 4 stays on track with active pre-sales forecast. Incheon, S. Korea, April 28, 2021 – Samsung Biologics (KRX: 207940.KS), the world’s leading contract 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.
manufacturing deal first entered into in 2018; collaboration will further enable global manufacturing of ublituximab Incheon, S. Korea and New York, April XX, 2021 – Samsung Biologics (KRX: 207940.KS), the world’s leading contract 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.
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."
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
Manufacturing Chemist's virtual roundtable series with top-tier CMOs and CDMOs representatives, James Choi, our SVP, Chief Information, and Marketing Officer, and Head of Investor Relations, gives insight on how we continue to leverage digitalization to optimize the client experience, and look for ways to implement new technologies to enhance and improve our processes. Read More All rights are reserved by the media that published this article.
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 “Driven. For Life.” what comes to mind?When I hear “Driven. For Life.”, it reminds me that Samsung Bi
manufacturing business highly depends on agile operation and transparency across the value chain. Preparing for digital transformation in advance can eliminate possible risks when faced with unexpected crises. Samsung Biologics quickly enabled innov-daptation (digital transformation) to overcome various challenges amid the pandemic. In this session, learn more about Samsung Biologics’ innovative efforts of digital transformation to enhance data integrity and process innovation to achieve client satisfaction.
Building a solid commercial drug strategy is centered on engaging partners strategically and at the earliest stage possible. Drug developers need partners with a wide range of experience that can guide their products to successful commercialization as each milestone is a critical step and any sort of disruption can cause severe loss in cost and time, and consequently, in delivering to patients in need. Samsung Biologics’ aseptic fill-finish services are expertly aligned and optimized to the client’s needs throughout the development and commercialization journey. Read More All rights are reserved by the media that published this article.
Manufacturing Chemist's virtual roundtable, James Choi, our SVP, Chief Information & Marketing Officer, and Head of Investor Relations, and representatives from a number of top-tier CMOs and CDMOs, discussed how we're approaching speed-to-market through the adoption of automation strategies that accelerate the pace of process development. Read more All rights are reserved by the media that published this article.
manufacturing strategies and solutions to increase efficiency and productivity, while investing in additional physical capacity and process automation. Read how contract manufacturers like us and other biopharmaceutical companies are evolving and optimizing digitally to improve lead times for rapid cycle process development, upstream capacity availability, and quality. Read More All rights are reserved by the media that published this article.
Manufacturing Chemist recently held a virtual roundtable with representatives from a number of top-tier CMOs and CDMOs to discuss how these organizations are responding to pressing issues in the pharmaceutical outsourcing sector. James Choi, our SVP, Chief Information, and Marketing Officer, and Head of Investor Relations, share what we're doing to address flexibility and the operational excellence demands of our customers from our Plant 4 expansion to our advanced digital solutions. Read more All rights are reserved by the media that published this article.
manufacturing operations. Sonya breaks down why quality and process improvement are so important, and how they make up a core element of the company’s “Driven. For Life.” mission. What are your job responsibilities at Samsung Biologics?I’m responsible for leading two process improvement projects that integrate all of the different cross-functional groups within Samsung Biologics. What does process improvement mean in the biopharmaceutical industry?Process improvement, for me, is an assessment of where we currently are, how our business processes are set up, how our quality processes are set up, and figuring out a way to make both of those better in order to ensure that we can manufacture for our clients with speed and quality. Process improvements in the biopharma sector are very tricky because we have to ensure that we’re building agility into our processes, while maintaining quality for the fact of patient safety. If we have slow, inefficient processes, then our patients are impacted because we can’t manufacture product faster. If we compromise on quality as a result of business process improvement, then now we’re risking patient safety. So one of the big things that I focus on at Samsung Biologics is ensuring we balance those two, faster and better. How does this ultimately impact our clients?Building business processes that are more efficient and have quality impact our clients because by doing so, we’re able to take on more capacity. From an agility perspective, we’re able to manufacture for a more diverse population of clients, and a result, more patients. If we don’t have quality processes in place, then our clients are directly impacted because now, we’re going to be slowed down if we have to investigate those events. How does data integrity and modernizing quality management go hand in hand?In order to build a mature quality system, we need to have mature data integrity integrated into our systems. We can use the data that we’re generating electronically to make predictive analytics and to look at the data proactively instead of reactively, and by doing so we can help support our clients better…Everything we do at Samsung Biologics is really for ensuring that our clients are satisfied. What makes Samsung Biologics’ culture unique?I think one of the unique aspects of Samsung Biologics’ culture is there’s a sense of collective pride across management and employees. Our pride comes from the fact that first of all, we are one of the top companies in the country, and so a lot of people want to work here, and they are proud to work here. The second thing is from the work that we actually do. We manufacture products for patient safety, [and] for patient lives, and so as a result, we’re very proud of the things we do here and it translates in how hard everybody works. What do you like most about working at Samsung Biologics?One of the great things about Samsung Biologics is that we are always striving for better. For example, we just finished building Plant 3 a few years ago, and we achieved number 1 capacity at a single site, but Samsung Biologics wanted to do better so we’ve already broken ground with our new Plant 4. That type of mentality actually translates down all the way through every single employee that we have and it’s one of the great things about working here because you’re always striving for better. When you hear the phrase “Driven. For Life.”, what comes to mind?For me, the phrase “Driven. For Life.” brings to mind the idea of just trying to build a better world. In my role, this translates to ensuring we have quality processes integrated into everything that we do. By building processes that have quality while also maintaining speed, we’re able to bring safe products to patients faster and better. Related ContentsSamsung BIO Insight Samsung Biologics embraces digitalization to provide next-level client satisfactionWebinars BMWS 2020 | Quality Digital TransformationWhitepapers Embracing Ne
manufacturing facility at the Incheon Free Economic Zone and automation is expected play a central role in this expansion. Read more about how Samsung Biologics will use technologies and knowledge developed at its three existing facilities to manage manufacturing at the new plant. Read More All rights are reserved by the media that published this article.
manufacturing activities in early 2023, catapulting Samsung Biologics upon completion to hold the world’s largest manufacturing capacity at a single site with multi-scale capabilities. The company also plans to further secure additional manufacturing facilities both locally and overseas to accommodate the evolving needs of global clients from multiple locations. In addition to its San Francisco CDO R&D Center, Samsung Biologics is currently in discussion to construct Bio Campus 2 in Songdo to further enhance its open innovation as a new growth engine for the next decade.
Manufacturing Science and Technology (MSAT) group and leader of Samsung’s Bio Women’s Club, Eri Kwon focuses her energy on what can be achieved for the greater good. Whether it’s providing mentorship to women in the company or inspiring a call to action within her team to drive change, Eri shares how her contribution to science and advocacy demonstrates a dedication to building a better life for humanity. What are your job responsibilities at Samsung Biologics? As a contract and 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
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
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
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’re deviating f
Manufacturing (CMO), Contract 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.
manufacturing contracts for COVID-19 treatments. Throughout the pandemic, the company demonstrated outstanding business agility in successfully managing its global supply chain and investing in technology enabled capabilities such as its Live Virtual Tour platform to ensure its ability to host client due diligence and regulatory inspections, helping to achieve a steady inflow of contracts valued approximately at $1.78 billion in 2020, 2.5 times higher than the previous year. Samsung Biologics also announced its 2021 plans to focus on the continuous operational efficiency of its plants 1, 2, and 3, and the early lock-in of contracts for its newest manufacturing facility, Plant 4. The company unveiled at the recent JP Morgan Healthcare Conference its long-term business plan to secure the next growth engine through business expansion and portfolio diversification strategies.
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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