SERACH RESULTS FOR" Manufacturing "
manufacturing has seen numerous developments that have helped reduce production process timelines, with the industry striving to standardize and simplify manufacturing processes. By developing comprehensive strategies that include deep knowledge of the regulatory arena, specialized contract development and manufacturing organizations (CDMOs) can streamline workflows, reduce production costs, and increase efficiency.Read more
Representing a versatile treatment modality for a variety of indications, messenger RNA (mRNA) technologies have paved the way for a new era of biotherapeutics used for therapeutic protein replacement, gene editing, cell therapy, vaccines, cancer therapy, and more over the last five years. Recognizing the transformative potential of mRNA-based medicines, it is even considered as the most suitable modality for the personalized therapeutics, and the biopharma industry has invested heavily in RNA technologies to support growing demand.Read more
manufacturing organization (CDMO), today hosted its inaugural Suppliers ESG Day, both at its Songdo headquarters and online, to share environmental, social, and governance (ESG) strategies and drive collective action to decarbonize. The company invited supplier companies and external ESG specialists to discuss ESG-related requirements and recommendations as well as share successful case studies. “Since a majority of healthcare emissions are created in the manufacturing supply chains, it is critical for us to work together at every level to become greener and more circular,” said John Rim, CEO and President of Samsung Biologics. “By connecting our suppliers with resources to help them assess their performance and opportunities to go beyond carbon emissions reductions, we are building a more transparent and responsible value chain.” Samsung Biologics has been conducting ESG assessments with its suppliers to minimize potential social and ethical risks, build a stable network, and establish green strategies towards decarbonization. Earlier this year, the company and members of the Sustainable Markets Initiative’s Health Systems Task Force—a public-private partnership launched at COP26 to accelerate the decarbonization of health systems—called on suppliers to commit to joint, minimum climate and sustainability targets, which aim to address emissions across the value chain and reduce the complexity of multiple asks. The company today also released its second report aligned to the recommendations of the Task Force on Climate-Related Financial Disclosures (TCFD). The report serves the company’s commitment to providing transparency on its approach to managing climate-related risks and opportunities across the business. “We are pleased to share our progress towards our emissions reduction targets and the responsible business practices we are implementing to mitigate climate change risks,” said Rim. “We will continue to amplify our efforts to achieve our carbon ambition, while continuing to support our clients to deliver therapies to millions of patients worldwide.” Highlights from the 2023 report include:· Establishing new milestones to achieve net zero by 2050 and engaging suppliers to reduce their direct emissions · Prioritizing Samsung Biologics’ sustainable leadership as an active member of the Sustainable Markets Initiative and champion for the Supply Chains Working Group; First CDMO to receive the SMI’s Terra Carta Seal· Joining the Sustainable Aviation Buyers Alliance to help reduce emissions through investment in Sustainable Aviation Fuel The full text of the report is available here.
manufacturing process. Given the complexity of their development and manufacturing, accelerating timelines becomes a pivotal success factor for the ADC market. In this whitepaper, Thomas Rohrer, Senior Director of Technical Support Bioconjugates, delves into how integrating development and production activities within a single outsourcing partner can dramatically streamline ADC development timelines and mitigate risks.
manufacturing industry arrived in Barcelona this week for the annual Convention of Pharmaceutical Ingredients (CPHI), which is now in its third decade. Busy as always, there was a notable sense of optimism at CPHI’s second year back in person. Although this year saw many companies needing to find efficiencies due to big-picture economic pressures, many are positive that things are looking up from here.Read more
manufacturing process to help detect potential contaminants and to ensure the quality and safety of the biopharmaceuticals. In this whitepaper, we share insights on the advantages of in-house biosafety testing at a single site and the importance of maintaining stringent GMP conditions for virus control management.
manufacturing organization (CDMO), today announced financial results for the third quarter of fiscal year 2023. "We have achieved a remarkable milestone with consolidated sales surpassing KRW 1 trillion in a single quarter, ultimately demonstrating our commitment to excellence and innovation," said John Rim, CEO and President of Samsung Biologics. "Our expanding partnerships with global leading pharmaceutical companies and a thriving sales backlog reflect the trust our clients place in us and our capabilities. Looking ahead, our expansion plans, including the construction of the ADC facility and Plant 5, will meet the increasing market demand and support our clients’ needs for both capacity and business diversification." THIRD QUARTER 2023 RESULTS In the third quarter of 2023, consolidated revenue exceeded KRW 1 trillion for the first time in a single quarter, marking an 18% increase from the KRW 873 billion reported in the same period of the previous year. This is attributed to a rapid increase in the operating rate of Plant 4 and a robust sales backlog, resulting in a projected over 20% annual growth in consolidated revenue. Consolidated operating profit for the third quarter of 2023 reached KRW 319 billion, while net profit was KRW 240 billion with an EBITDA of KRW 457 billion. On a standalone basis, the company reported KRW 883 billion in revenue for the third quarter of 2023, reflecting a 31% increase from KRW 675 billion in the same period in the previous year. Operating profit reached KRW 382 billion, marking a 23% increase from the prior year. The company also expanded its strategic partnerships to include 14 of the top 20 global pharmaceutical companies, further solidifying the company’s position as a trusted CDMO partner. As of October, Samsung Biologics has accumulated contracts worth over USD 11.8 billion, which includes the previously announced long-term partnership with Pfizer and an expanded strategic agreement with Bristol Myers Squibb. [Consolidated Earnings, KRW billion] Q3’23 Q3’22 YoY Change Revenues 1,034 873 +18.4% Operating Profit 319 325 -1.9% Net Profit 240 129 +86.0% EBITDA 457 409 +11.6% FISCAL YEAR 2023 OUTLOOK Samsung Biologics is committed to meeting the growing demand for high-quality biologics. The company’s expansion plans are on track, with the new Plant 5 set to commence operations by April 2025, adding an 180KL of capacity. As the first facility of Samsung Biologics’ second Bio Campus at its headquarters in Songdo, South Korea, Plant 5 is expected to have the shortest construction timeline at 24 months, made possible by the company’s standardized design, accumulated operational excellence, and proven expertise. To expand its business portfolio, Samsung Biologics’ separate antibody-drug conjugate (ADC) manufacturing facility is expected to be cGMP-ready within 2024 in order to develop and explore innovative technologies for next-generation biomedicines. This aligns with the company’s strategic investments, made through the Samsung Life Science Fund, to support biotechs like AimedBio and Araris Biotech AG who are pioneering ADC technology. Samsung Biologics also continues to engage and drive action in the sustainability front. In July, together with global leaders from across the healthcare sector under The Sustainable Markets Initiative Health Systems Task Force, Samsung Biologics President and CEO John Rim announced an open letter, calling on suppliers to commit to joint, minimum climate and sustainability targets. The comp
manufacturing services, and seamless transitions for biologics from early stages of development to large-scale commercialization· The partnership will streamline gene to IND process to accelerate lead candidate selection and advance CMC along clinical development· Multi-year collaboration expected to support sustainable growth of the biopharmaceutical industry and allow Samsung Biologics to further expand its footprint into the European market Incheon, South Korea, Paris, France, Munich, Germany October 24, 2023 – Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), and Kurma Partners, a European venture capital firm in healthcare and biotechnology, today announced a strategic partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies. Under the terms of the multi-year agreement, Samsung Biologics will provide customizable chemistry, manufacturing, and control (CMC) development services for Kurma Partners’ portfolio companies to streamline the gene to Investigational New Drug (IND) process, de-risk uncertainties in CMC, and accelerate the lead candidate selection through entry into first-in-human studies with seamless transitions along further clinical development. The portfolio companies will be able to leverage Samsung Biologics’ state-of-the-art facilities, proprietary technology platforms, and CMC-related expertise. “As we look to further expand our business opportunities globally, we are pleased to collaborate with Kurma Partners to support the growth of pioneering biotech companies,” said John Rim, President and CEO of Samsung Biologics. “With our in-depth knowledge on effective scale-up strategy and a diverse portfolio of proprietary platform technologies, we are looking forward to providing robust CMC solutions to reduce uncertainties, ensure regulatory compliance, and ultimately maximize manufacturing efficiency for our clients.” “We are very excited to partner with Samsung Biologics, a world-leading CDMO with capabilities of highest industry standards. This will greatly benefit our portfolio of Kurma Biofunds and Kurma Growth Opportunities Fund in advancing large molecule biologics from discovery to the market.” said Daniel Parera, M.D., Partner at Kurma Partners. The latest agreement reflects Samsung Biologics’ continued commitment to support emerging biotech companies on their drug development and manufacturing journey as well as further increase its business presence in major sectors with a focus on the U.S. and European markets.
manufacturing, and control (CMC) solution packages and new proprietary development platforms – S-KiH and S-GlynTM – can accelerate clients’ drug development journey and maximize the potential of their molecule. Samsung Biologics will also share its latest expansion plans regarding the construction of its new Plant 5, the first facility of its second Bio Campus at their Songdo headquarters. When operational by April 2025, the company will continue to hold the world’s largest manufacturing capacity with 784,000 liters. Samsung Biologics is also adding an antibody-drug conjugate (ADC) facility, which is expected to be cGMP-ready within 2024. As part of its ongoing sustainability efforts, the company has built an eco-friendly booth with reusable materials and reduced waste by incorporating QR technology within the booth. Meet the Samsung Biologics team at Booth #3K40 or schedule a meeting here
manufacturing, and control (CMC) services are fundamental to ensure quality, safety, and efficacy standards. Therefore, clients search for CDMO companies that can provide this model to help improve and streamline their operations. This whitepaper introduces Samsung Biologics’ customized CMC solutions comprising three packages - Simplified IND package, Comprehensive IND package, and Enhanced CMC package, and how we can help clients to overcome hurdles during the development stage.
manufacturing of a Bristol Myers Squibb commercial antibody cancer drug substance. Bristol Myers Squibb and Samsung Biologics have an existing manufacturing agreement for a commercial antibody cancer drug and have expanded the strategic relationship over time. Under the terms of the new agreement, Samsung Biologics will provide drug substance manufacturing for an antibody cancer drug substance at the company’s latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea. “Our relationship with Bristol Myers Squibb spans over a decade, and we are proud and excited to help bring important medicines to patients around the world,” said John Rim, President and CEO of Samsung Biologics. “This collaboration with Bristol Myers Squibb underscores our commitment to expediting the delivery and ensuring the continuous supply of client pipelines, enabled by our commitment to manufacturing quality, innovation, and capacity.”
manufacturing facility with the goal to complete construction in 2024. “We are pleased to support AimedBio for their pipeline of innovative candidates towards the clinic,” said John Rim, President and CEO of Samsung Biologics. “As part of our continued efforts in fostering next-generation technologies, we hope this investment paves the way for future collaborations on the development and manufacturing of new drugs.”
manufacturing and control (CMC) activities are essential to drug development to meet quality, safety, and efficacy standards. It includes the development of manufacturing processes, quality control tests, and stability studies. Tailored to achieve a client’s end goalWhile monoclonal antibodies continue to lead the biologics market, innovation has increased demand for other modalities, such as bispecific antibodies, fusion proteins, and antibody-drug conjugates. Successful drug development relies on a thorough understanding of a molecule’s characteristics. Each development journey is unique and complex, while each client’s needs are diverse—meaning flexible and customized approaches are essential to pave the way to the clinic. Building on its proven track record of success as a contract manufacturing and development provider, Samsung Biologics has optimized development services incorporating innovative processes and advanced platforms** to accommodate clients’ evolving needs - supporting their journey from gene to investigational new drug (IND) and/or beyond.**S-CHOICE® is a high-performing CHO-K1-based cell line development that improves titers.**S-DUAL™ is an advanced high-yield bispecific antibody platform that enables high binding affinity to produce higher titer and purity.**DEVELOPICK™ provides selection guidance to predict candidates with the best developability to minimize time and cost and maximize efficiency. To proactively satisfy and serve a client’s specific needs, Samsung Biologics has packaged its drug development services into three programs—each designed to ensure maximum flexibility and meet the client’s goals per their development stage. Utilizing pre-built modules, Samsung Biologics implements a highly streamlined approach, while assessing potential risks that may occur along the way. This framework gives clients a guideline of where to start and what to expect—speeding up the process and mapping out the strategies. Simplified IND PackageThe simplified IND package focuses on IND Phase I, utilizing Samsung Biologics’ proprietary platforms. The key priority is accelerating the timeline, while ensuring appropriate quality and effectiveness requirements. The company has designed the program to meet a timeline of 11 months for monoclonal antibodies and within 13 months for complex molecules. Comprehensive IND PackageThe comprehensive IND package provides a multi-faceted scope to clients who wish to mitigate risks and opt for a more stable development process. The service consists of robust data items, including CMC data and stability studies, while quality attributes beyond IND Phase I are assessed in advance to measure potential risks that may occur in the late phase. This program aims to support clients who want to take their pipelines to commercialization by pursuing a more detailed and comprehensive service with add-on options for complex mechanisms. Enhanced CMC PackageThe enhanced CMC package focuses on improving productivity. This program facilitates end-to-end provision through the replacement of cell lines, processes, or formulation to meet the client’s need for improvement and ensure a seamless journey to commercialization. Through this package, clients can leverage Samsung Biologics’ experience and expertise based on proven track records to enhance their manufacturability in need of improvement, while maintaining other quality attributes necessary to move on to the next development phase. Each program—designed based on years of experience and expertise—comes with basic, indispensable requirements. Clients can also add a range of comprehensive service options to fine-tune their own best-fit package, depending on their development needs and molecule type. A trusted CDMO partner to accelerate drug development success As drug developers prioritize a first-to-market approach, a growing number of clients want to leverage a CDMO’s platform for faster development and their regulatory expertise to ov
manufacturing. The company has invested in capacity and resources to ultimately give clients supply access in order to bring their product to market quickly. In this article, explore how Samsung Biologics is committed to working closely with its customers, which range from large biopharma to growing biotech companies, to deliver flexible and quality solutions that will facilitate their journey seamlessly. Driving flexibility to manage demand Plant1 30,000L 5K x6 Plant2 154,000L 15K x10 1K x2 1K x2 Plant3 180,000L 15K x12 Plant4 240,000L 15K x12 10K x6 Plant5 180,000L 15K x12 Samsung Biologics is continuously expanding its manufacturing capacity while keeping flexibility at the forefront. The company's four advanced manufacturing plants, including the newly completed Plant 4, are designed to swiftly adapt to the evolving needs of its diverse client base. "We offer a range of bioreactor capacities from 1,000 to 15,000 liters, enabling us to provide small to large scale production. With state-of-the-art facilities and optimized timeline, we consistently produce high-quality biopharmaceuticals that meet our clients' expectations," said Soyeon Ahn, Senior Director, Plant 4 Upstream and Downstream Manufacturing. Strong client relationships at Samsung Biologics are forged through continuous efforts to identify and address improvement points during production. Regular evaluation sessions for each project focus on enhancing equipment and processes to maximize efficiency."We collaborate with clients to fine-tune process like control logics of critical parameters. These improvements not only enhance yield, but also contribute to a smoother production process," Ahn added. Ensuring quality at every phase Quality management is a non-negotiable in biopharmaceutical manufacturing, and Samsung Biologics excels in this regard. The company has established thorough quality control measures for the entire production process, from cell culture conditions to comprehensive process monitoring and investigations."We're not just scaling up production; we're scaling up quality. Our commitment to quality management is unwavering, and it's reflected in every aspect of our operations," Ahn highlighted. Samsung Biologics maintains pristine conditions at each of its manufacturing sites, regularly inspecting the equipment. "Considering that most production disruptions result from equipment issues, our well-maintained and new facilities significantly contribute to the high quality of our products," Ahn added.Fostering an environment of continuous improvement, the MSAT, Quality, and Facility teams work tirelessly to minimize risk and maintain operational excellence.Adopting new technologies to improve efficiency Samsung Biologics is taking steps to leverage digitalization throughout the entire manufacturing process. This commitment to innovation extends across all facilities, resulting in continuous improvements in productivity and operational efficiency. In Plant 4, several cutting-edge technologies were introduced to bolster efficiency and quality. A single-use alternating tangential flow (ATF) filtration system significantly reduces contamination risks when changing products, ensuring a high level of product purity and safety. The company has not only increased product yield but also cut processing times, by incorporating a continuous solids discharge centrifuge ball to separate mixture of solids. Samsung Biologics has also introduced AxiChrom™ technology to prevent microbial contamination (bioburden) and simplify the purification column packing process. The upcoming fifth plant, set to be completed in 2025, will further integrate automation and digital transformation throughout the entire production process to improve efficiency and consistency. By focusing on flexibility and quality management in its biopharmaceutica
manufacturing organization (CDMO), today announced the appointments of Gail Ward as Executive Vice President and Head of the Quality Center, and Sojeong Lee as Vice President and Head of Regulatory Affairs. A seasoned pharmaceutical executive, Ward has almost four decades of extensive quality experience in both large pharmaceutical companies and entrepreneurial biotech companies. Prior to joining Samsung Biologics, Ward served as Head of Quality at ProKidney Corporation, a late clinical-stage biotech company specializing in treatments for chronic kidney disease. Her experience also includes quality assurance leadership roles at Celltrion, and senior positions at Diosynth RTP and Biogen. Samsung Biologics also appointed Sojeong Lee as the Vice President and Head of Regulatory Affairs to oversee and manage the company’s response to and relationship with global regulatory agencies. Prior to this role, Lee served as the Regulatory Affairs Director at GlaxoSmithKline in Korea.
How Samsung Biologics fostered a collaborative and transparent environment to meet a client’s time-sensitive project deadline Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics A fundamental consideration when a biotech company seeks to outsource its project from cell line development to Investigational New Drug (IND) submission is the selection of a CDMO partner who can offer transparency and find innovative solutions. Open communication between a biotech and CDMO forges a trusted partnership, enables close collaboration, and facilitates timely problem-solving, ultimately leading to end-goal success. This was the case for Bolt Biotherapeutics Inc., which needed a competitive CDMO partner to help advance its molecules to IND filing within a condensed timeline. “Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics. “Our earned confidence in Samsung Biologics’ end-to-end drug development service enabled us to take full advantage of its quality-centric, speedy execution and readily available bioreactors of various sizes to achieve our project goal.” Creating the best solution through transparent collaboration Bolt is a clinical-stage biotechnology company committed to developing new medicines to address key unmet medical needs for cancer patients. The California-based biotech company is developing a myeloid modulating agonist antibody (BDC-3042) that could potentially convert tumor-supportive white blood cells, or macrophages, into ones that kill tumors. Bolt hopes to gain authorization to begin testing its antibody in clinical trials as soon as possible and has partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission. To deliver on its client’s needs, Samsung Biologics proposed a 12-month timeline from cell line development to IND filing. “Any CDMO could propose a very fast timeline,” Ihle said. “But if it wasn’t logical, we wouldn’t trust the CDMO. What Samsung proposed was fast but believable.” While executing the project, however, there was a hurdle that could delay the timeline. During the process development phase, an unexpected impurity was detected, and an additional purification column was needed to ensure the quality of the vials. Samsung Biologics and Bolt confronted the problem immediately, transparently shared each other’s concerns, and “talked through those in a collaborative problem-solving way,” Ihle said. In a collective effort to bring creative solutions to the problem, Samsung Biologics shared its years of cumulative project know-how with processing purification using multiple columns, while Bolt shared its scientific and experimental knowledge. Both teams eventually managed to implement the extra-column purification process without delaying the project. “This is why transparency is so important to me,” Ihle said. “It helps lead to successful execution and creating not just good enough solutions but the best solutions.” Emboldening hope for successful drug development, envisioning future partnership Successful teamwork driven by the transparent sharing of information between Samsung Biologics and Bolt ultimately led BDC-3042 to be filed for IND application on schedule with the United States Food and Drug Administration (US FDA). When asked to describe the moment he first learned of the successful completion of the drug-development project, Ihle summed it up in one word. “It’s hopefulness,” he said. “We invested so much effort and passion into the project. And getting to the point of actually having the high-quality drug in a vial ready to administer to p
manufacturing organization (CDMO), today announced financial results for the second quarter of fiscal year 2023. “Our consistent delivery of quality service and operational excellence, coupled with our expanded strategic partnerships with top global pharmaceutical companies, have been pivotal in driving stable revenue growth in the second quarter,” said John Rim, CEO and President of Samsung Biologics. “With the full completion of Bio Campus I offering 604,000 liters of capacity and our Bio Campus II expansion with Plant 5 on track to come on line by April 2025, we are well-positioned to meet the growing demands of the market.”SECOND QUARTER 2023 RESULTSSamsung Biologics demonstrated improved profitability in both the second quarter and the first half of the year. The full utilization of Plants 1 through 3 and expanded partnerships with major pharmaceutical companies played a key role in delivering solid results. In the second quarter of 2023, the company achieved a consolidated revenue of KRW 866.2 billion, marking a 33.0% increase compared to KRW 651.4 billion in the second quarter of the previous year. Operating profit reached KRW 253.4 billion, 49.4% higher than the prior-year period. Net profit for the second quarter of 2023 was KRW 184.9 billion, with an EBITDA of KRW 362.1 billion. The first half of 2023 saw a consolidated revenue of KRW 1,587.1 billion and an operating profit of KRW 445.2 billion.[Consolidated Earnings, KRW billion] Q2’23 Q2’22 YoY Change Revenue 866.2 651.4 +33.0% Operating Profit 253.4 169.7 +49.4% Net Profit 184.9 152.0 +21.6% EBITDA 362.1 258.6 +40.0% On a standalone basis, Samsung Biologics recorded KRW 637.2 billion in revenue in the second quarter 2023. Operating profit reached KRW 254.1 billion, showing a substantial 47.8% growth compared to the same quarter of the previous year. The revenue generated from Plant 4 will be reflected in the third quarter results and is expected to enhance the company’s performance in the coming quarters. FISCAL YEAR 2023 OUTLOOK Building upon the recent completion of Bio Campus I, Samsung Biologics reaffirmed its commitment to meeting the increasing demand for high-quality biologics. The company unveiled its expansion plans, with the aim of commencing operations at its fifth plant by April 2025. As the first facility of Samsung Biologics’ second Bio Campus, Plant 5 is expected to have the shortest construction timeline, and once completed will add 180,000 liters of additional capacity. The company also expanded a number of large scale manufacturing contracts with leading pharmaceutical companies including Roche, Pfizer, and Novartis, securing over KRW 2 trillion in sales backlog as of July, exceeding the cumulative sales backlog of the previous year. Samsung Biologics also released its third annual ESG report, showcasing its ongoing efforts towards sustainable practices and environmental stewardship. The company has made significant progress in reducing its carbon footprint and aims to achieve net zero GHG emissions in its operations, along with a transition to 100% renewable energy by 2050. The company remains dedicated to responsible business practices that generate long-term value for stakeholders and the communities it serves. For more details on performance and financials, please refer to the Earnings Release.
manufacturing organization (CDMO), today released its 2023 Environmental, Social and Governance (ESG) Report. The annual report outlines the company’s progress toward its sustainability goals and the strategies to fulfill its social responsibilities and create long-term value for stakeholders.“Samsung Biologics is fully committed to engaging in sustainable business practices for the positive impact it has on our clients, society, and the wider community,” said John Rim, President and CEO of Samsung Biologics. “We will continue to leverage our expertise and experience to accelerate the delivery of net-zero healthcare and engage with our suppliers and partners to amplify our collective efforts.” Key highlights of the report include: Establishing a net-zero pathway: As part of the company’s mission to deliver net zero by 2050 or earlier, Samsung Biologics established new milestones: to cut 32% of direct emissions by 2030 and 62% by 2040 while reducing 36% of suppliers’ emissions by 2030 and 73% by 2040. Last year, the company also committed to 100% renewable power through the RE100 initiative. Prioritizing sustainable leadership: In recognition of the company’s commitment to the creation of sustainable markets, Samsung Biologics was the first leading biopharma CDMO to receive the Sustainable Markets Initiative’s (SMI) Terra Carta Seal, which is awarded to companies whose ambitions align with those of the Terra Carta, a recovery plan for Nature, People, and Planet. Samsung Biologics is also engaging its suppliers as part of a broader Supply Chains Working Group initiative within the SMI’s Health Systems Task Force to identify carbon reduction options to achieve net zero in its supply chain. Implementing responsible business practices: Samsung Biologics joined the United Nations Global Compact, a major global corporate sustainability initiative, to demonstrate its continued commitment to sustainable business practices, as well as to implement the initiative’s 10 principles addressing human rights, labor standards, the environment and anti-corruption. Strengthening risk management practices and transparent corporate governance: To address risks at all levels, Samsung Biologics implemented an enterprise-wide risk management system to strengthen the company’s sustainable operations. The company established an ESG committee to oversee the overall governance, reporting, and policies of ESG-related tasks. For transparent governance, Samsung Biologics obtained ISO37001 (Anti-Bribery Management Systems), a framework for implementing reasonable and proportionate measures to prevent bribery and corruption. Accelerating action across the supply chain: As a sustainable CDMO partner, Samsung Biologics conducted ESG assessments with its suppliers to minimize potential risks, build a stable network, and establish green strategies to achieve carbon neutrality across supply chains. Nurturing global talents: The company committed to building a strong bio community by fostering local and global experts to drive innovation and encourage growth while giving back to local organizations through volunteer programs. Samsung Biologics also hosted representatives from the World Health Organization’s human resource training hub to offer biologics development and manufacturing courses.“Samsung Biologics is engaged in this work because we want to leave the world better than we found it,” Rim added. “2022 was a foundational year for us, and we are steadfast in our commitment to drive substantial progress and make a more meaningful impact in 2023 and beyond.” The full report is available here.
South Korea's Samsung Biologics (207940.KS) announced on Tuesday two deals with Pfizer (PFE.N) worth a combined $897 million to manufacture products for the U.S. pharmaceutical giant. The latest deals will see the biotech division of the Samsung Group produce biosimilar products ranging from oncology and inflammation to immunotherapy in the period to 2029 at its new Plant 4 in South Korea.Read more
manufacturing. About 40 trainees and staffs toured the company’s biomanufacturing facilities to learn about the production process involved in vaccine and biopharmaceutical manufacturing and quality control. Samsung Biologics has taken part in the training program since last year after the WHO designated Korea as a “Global Biomanufacturing Training Hub” to serve low- and middle-income countries seeking to produce biologics. The company is committed to building a strong bio community by fostering both local and global experts to drive innovation and encourage growth.
manufacturing water for injection (WFI), sustainable operation systems using geothermal power and municipal hot water have also been implemented into the facility’s structure, with the benefit of reducing over 11,000 tCO2eq of GHG emissions as well as operating costs. “Plant 5 is designed to facilitate the transition to renewable energy from construction to future operations and to achieve our net-zero goal. We will continue our efforts to increase on-site renewable energy generation,” Min explained. Paving the way for a greener future Samsung Biologics recently published its annual ESG report, reflecting the company’s latest sustainability efforts. As part of the company’s mission to deliver net zero by 2050 or earlier, Samsung Biologics established new milestones: to cut 32% of Scope 1 and 2 emissions by 2030 and 62% by 2040. In April this year, Samsung Biologics established an enhanced recycling area in Bio Campus I called the Green Center, aiming to achieve an 80% recycling rate. This facility will also be added to future manufacturing sites. The company introduced RFID technology to improve medical waste management efficiency by automatically identifying and tracking hazardous medical waste. “With these sustainable practices, we are further strengthening our commitment to energy efficiency, renewable energy, and the reduction of our environmental footprint. We are taking steps toward a greener future while reducing costs and generating positive savings,” Min said. As a leading sustainable CDMO partner, Samsung Biologics understands the seriousness of climate change and its impact on public health; therefore, we are stepping up to the challenge of leading our industry toward a more sustainable future. “Just as our partners trust us to deliver the highest quality biomedicines, we are committed to building on that foundation to deliver sustainable outcomes,” he added. Driven. For a Sustainable Life. Related contents Posters Plant 5 brochure Press release Samsung Biologics releases 2023 ESG report Sustainability 2023 ESG report
manufacturing. In this article for the Innovations in Pharmaceutical Technology magazine, Yingji Jin, a Lead Scientist in our Cell Line Development Group, discusses how Samsung Biologics' CLD platform with high-titer capabilities can help streamline biologics manufacturing to deliver essential treatments to patients faster.Read more
manufacturing capacity at 784,000 liters in total. “In comparison to the same-sized Plant 3 that was operational in 35 months, we’ve been able to reduce construction time by roughly a year to set a new record,” said John Rim, CEO and President of Samsung Biologics at a press conference. “We continue to secure orders, so we have decided to speed up construction to close the gap between demand and supply.” The new Plant 5 marks the first phase of the company’s second Bio Campus, which will house three additional plants for a total biomanufacturing capacity of 720,000 liters, as well as an Open Innovation Center for biotech incubation. Samsung Biologics’ expansion has been made possible thanks to the continued trust and strong partnerships with clients. Plants 1 through 3 are under full utilization, while there’s been continued orders for Plant 4, the world’s largest single biomanufacturing site, which was fully complete on June 1. “Plant 5 is designed to meet the immediate capacity needs beyond Plant 4, large volume products in the market, as well as for new opportunities, such as treatments for Alzheimer’s disease,” said Kevin Sharp, Vice President and Head of Samsung Biologics America - Sales. “Plant 5 will incorporate the knowhow and efficiencies acquired from the existing four plants to make it more effective to support client products.” A SUSTAINABLE CDMO PARTNER Samsung Biologics made an impact at BIO with its vibrant, eco-friendly booth, made from wood and other plastic-free materials, while brochures were downloadable via QR codes. “Sustainability is a core component of the way we work and engage with clients,” said James Choi, Executive Vice President, Chief Marketing Officer and Head of Global Public Affairs. “By moving towards more sustainable alternatives at every level of our business, even events, we’re standing behind our commitment to decarbonize and achieve net zero by 2050 or earlier.” The booth had a large display playing the Samsung Biologics’ new branding video for Plant 5 and BIO Campus II to give visitors a better understanding of the new facilities. It also showcased the company’s capabilities in CMO, CDO, mRNA, ADC and sustainability. The Samsung Biologics team also actively used the convention to engage with existing and potential clients for future development and manufacturing projects, while the company co-hosted the main reception event for key clients and BIO visitors for networking. “The BIO conference is really important for us – we have a large presence and we have an amazing booth where people stop by to see and learn about our facilities,” said Eric Hsu, Head of Key Account Management Sales Execution Group. “We’ve met with a lot of people, both current clients and expected clients, so it’s really important that we do this to help the growth of the company, share our capabilities and future services.” Samsung Biologics will continue to leverage its unparalleled experience and expertise to add unbeatable value to our existing services and deliver long-term success for clients. Related Content Press Release Samsung Biologics accelerates timeline of new fifth plant to be operational by April 2025
manufacturing of Pfizer’s multi-product portfolio. Samsung Biologics and Pfizer entered into an initial manufacturing agreement in March 2023 for a Pfizer product. Under the terms of the new agreement, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology. Samsung will use its newest facility, Plant 4, for the manufacturing. “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe,” said John Rim, President and CEO of Samsung Biologics. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with even more flexible and advanced manufacturing technology.” “Pfizer is excited to continue our strategic partnership with Samsung Biologics Ltd. that aims to enable greater access to medicines for more patients across the world,” said Mike McDermott, Chief Global Supply Officer, Executive Vice President, Pfizer. “This commitment is a reflection of Pfizer’s trust in the Korean Pharmaceutical industry to address emerging health challenges.” “Our collaboration with Samsung Biologics will have the potential to significantly improve the lives of patients globally,” added Dong-Wook Oh, Pfizer Korea Country Manager.
manufacturing capacity at 784,000 liters upon completion of the newest plant- Key features of Plant 5 include seamless process integration and optimization, advanced automation and sustainable systemsINCHEON, S. KOREA, June 6, 2023 – While attending the 2023 BIO International Convention, Samsung Biologics (KRX:207940.KS), a leading contract development and manufacturing organization (CDMO), revealed details of the company’s future expansion plan to have its new fifth plant operational by April 2025. Recently on June 1, the company fully completed its latest and the world’s largest biomanufacturing plant, Plant 4. The move reinforces Samsung Biologics’ unmatched speed and commitment to providing partners with high-quality services and products in response to the surging demand for biologics.As the first facility of Samsung Biologics’ second Bio Campus at its headquarters in Songdo, South Korea, Plant 5 is expected to have the shortest construction timeline, made possible by the company’s standardized design, accumulated operational excellence, and proven expertise acquired through the construction of its existing four plants. The new plant will add a capacity of 180,000 liters, and upon its completion, Samsung Biologics will maintain the world’s largest biomanufacturing capacity at 784,000 liters.“Over a decade ago, we committed to bringing innovative solutions to our partners, and we’ve successfully delivered on that commitment with each new plant. Now building on this foundation, Plant 5 will leverage our unparalleled experience and expertise to deliver long-term success for our clients,” said John Rim, President and CEO of Samsung Biologics. “By expediting our capacity expansion and providing fully integrated services, we hope to close the gap between the demand and supply of life-saving biomedicines.”Dubbed the Dream Plant for its flexibility and ability to meet clients’ goals, Plant 5’s key features also include seamless process integration and optimization as well as advanced automation to consistently deliver high productivity and quality throughout its operations. The new plant will also incorporate sustainable systems to support the company’s commitment in achieving net zero greenhouse gas emissions by 2050 or earlier.Plant 5 ultimately marks the first phase of Samsung Biologics’ second Bio Campus. In July 2022, the company purchased 357,360m2 of land for the expansion, which will feature an Open Innovation Center for biotech incubation and four plants for a total capacity of 720,000 liters.All facilities will be connected to maximize output and efficiency with automated logistics and will incorporate next-generation technologies with fully digitalized systems to offer seamless client communication. Upon the completion of Bio Campus II, Samsung Biologics will hold a total capacity of 1.324 million liters. “This strategic investment allows us to support our clients across the entire product lifecycle,” said Rim. “Through innovation and sustainability, Bio Campus II will add unbeatable value to our existing services and offer expanded capacity in record time to enable their success.”
manufacturing plant—Plant 4—Samsung Biologics’ Bio Campus I has allowed the company to achieve the largest total capacity within the shortest time in the industry, while providing a wider breadth of solutions for our clients. The company has partnered with over 100 global pharma companies to manufacture biopharmaceuticals, with utmost priority on patient safety and quality. In this article, we explore Samsung Biologics’ quality competitiveness and expertise built over the years and how this has become the backbone of the company’s successful expansion and rapid growth. Yunjin Hong, Senior Director and Head of Quality Assurance, credits the company’s quality competitiveness to its robust and extensive quality management system. Throughout its 12 years of operation, Samsung Biologics has been inspected and audited over 200 times by global and local regulatory bodies as well as by clients. During that time, the company has fine-tuned its own quality system and processes to meet strict global quality regulations and practices. “Samsung Biologics has implemented digitalization features for better quality management by leveraging IT expertise to deploy a ‘person-in-plant’ concept, giving clients direct access to records related to their products,” said Hong. “Our clients have really been satisfied with our system, with access to necessary documents and records on demand.” Samsung Biologics launched an integrated electronic document and quality management system, which allows authorized employees to manage quality records in a single platform, ultimately improving cGMP (current Good Manufacturing Practice) recording tracking, documentation, and assessment. The system also gives external clients transparent, real-time, and direct access to request, review, and approve documents and records related to their products. Samsung Biologics’ quality competitiveness can also be attributed to its rapid expansion, according to Hong. “With each plant we’ve built, we continuously acquire more know-how and opportunity to adapt new regulations and standards,” said Hong. “This allows us to provide the highest quality to our clients, while maintaining the most current compliance requirements.” Furthermore, one team oversees the entire quality process across Plants 1-4, enabling unified and consistent management. Thanks to this, it has been able to efficiently implement a quality system and minimize potential risks, even in new plants. Samsung Biologics is also championing an FDA initiative known as Quality Management Maturity, which is intended to raise awareness – at all levels of management in the pharma industry – about how to best achieve quality objectives. The goal of this initiative is for drug manufacturers to have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. According to Hong, Samsung Biologics’ quality system has advanced immensely since its foundation. It allows them to take a proactive approach by identifying potential deviations in advance. Corrective and preventive actions can be designed pre-emptively, rather than taking measures after an issue is detected. She added that the company is also trying to promote a quality mindset across the entire management. “We’re planning to launch training programs for not just quality-related personnel, but the company as whole. This way, we can all understand the need for continuous quality improve and take initiative,” said Hong. “It’s about making GMP a culture.” Samsung Biologics will continue to advance its quality system and accelerate the development and manufacturing of high-quality, life-saving treatments for patients around the world. Plant 4 will be fully operational soon, and there will be additional plants to come. The company is committed to
Manufacturing and Control at Aronora, at Samsung Biologics’ headquarters in Songdo, South Korea. While technical expertise, quality resources, and flexibility are all fundamental to cell line development, a core component of the process is reliable collaboration. The right cell line development partner can help biotech companies rise above the complexity to deliver high productivity and maintain high cell viability, which is critical to maximizing the likelihood of advancing the project. Aronora Inc., a clinical-stage biotechnology company developing next-generation therapeutics for blood clotting diseases, partnered with Samsung Biologics to ensure its development success. Selection centered around quality and expertise Based in Portland, Oregon, Aronora is currently undergoing clinical development for Gruticibart, a recombinant monoclonal antibody (mAb) that is specifically designed to treat and prevent blood clots (thrombosis), without causing increased bleeding risk. To build a baseline for success and advance their molecule, Aronora’s team sought to collaborate with a CDMO that has experience in developing viable cell lines with a high titer, a gram-per-liter concentration of viable antibodies extracted from a bioreactor. “When selecting a partner for this product, we needed someone with experience developing mAbs and a good reputation for quality,” said Christina Lorentz, Ph.D., Director of Clinical Operations at Aronora. “What made the difference was Samsung Biologics’ expertise in the antibody space–this was ultimately the biggest driver in the CDMO selection process. The Samsung Biologics’ team also instantly understood our specific needs and were wholeheartedly collaborative throughout the entire process.” Advanced solutions to achieve a high-titer cell line Acquiring a high-titer cell line is a cornerstone for successful drug development. It means the cell line has a high-concentrated antibody that neutralizes antigens, or target viruses, giving it more potential to become a commercialized drug. Through its partnership with Samsung Biologics, Aronora was able to take the right step to advance its molecule while saving time and cost. Before partnering with Samsung Biologics in 2022, Lorentz said Aronora had a cell line with “a very low titer that was essentially not commercially viable,” adding that redesigning its cell line helped to revitalize the development program and give Aronora momentum as they move toward commercial manufacturing. “It’s extremely important to the viability of the program to be able to generate a sufficient amount of antibodies for a certain amount of money,” she said. “If your titer is low, you have to run these giant bioreactors – which is expensive – just to get a small amount of antibodies.” Samsung Biologics’ proprietary platform¬ S-CHOice® helped to steer Aronora’s development, while minimizing risks. Enhanced by a know-how of utilizing methionine sulfoximine in cell line development, S-CHOice® generated a cell line with a nearly tenfold amount of titer than what Aronora’s previous cell line had. Recalling the moment Lorentz learned of the high level of titer S-CHOice® brought to the new cell line, she said cell line developers at Samsung Biologics essentially energized the program. “If cell line development fails, then the whole program has a risk of failing,” she said. “So knowing our new cell line has a high titer means the program has regained significant momentum.” A trusted partner offering seamless communication Close-knit communication is also imperative when it comes to collaborating on a project like cell line development. Lorentz, who also manages numerous projects at Aronora, found the enthusiasm and openness of Samsung Bi
manufacturing organization (CDMO), today announced financial results for the first quarter of fiscal year 2023. "Enabled by the groundwork we have laid with our strategic capacity expansion plans, our first quarter results demonstrate stable revenue growth as we continue to drive strong operational excellence and business agility with full utilization of Plants 1, 2, and 3,” said John Rim, CEO and President of Samsung Biologics. “With continued partnership expansion with global pharma, we are focused on achieving sustainable growth and securing more robust capacity with Plant 4 set to be fully operational by June and the groundbreaking of Plant 5 to occur later this year. We will continue to anticipate client needs and execute on opportunities to meet the increasing market demand for biomanufacturing capacity." FIRST QUARTER 2023 RESULTS For the first quarter 2023, Samsung Biologics recorded a consolidated revenue of KRW 720.9 billion and an operating profit of KRW 191.7 billion. First quarter 2023 net profit reached KRW 141.8 billion, a slight decrease from KRW 146.9 billion in the first quarter a year ago due to the elimination of intercompany transactions and PPA amortization after the inclusion of Samsung Bioepis. On a standalone basis, Samsung Biologics reported KRW 591.0 billion in revenue in the first quarter 2023, attributable to new and extended manufacturing deals. Operating profit posted KRW 234.4 billion, an increase of KRW 58.4 billion from the prior-year period, as a result of maximized operational efficiency amid full utilization of Plants 1, 2 and 3. Samsung Biologics has achieved a continuous revenue increase for 13 consecutive quarters. [Consolidated Earnings, KRW billion] Q1’23 Q1’22 YoY Change Revenue 720.9 511.3 +209.6 Operating Profit 191.7 176.4 +15.3 Net Profit 141.8 146.9 -5.1 EBITDA 292.4 218.7 +73.7 FISCAL YEAR 2023 OUTLOOK Samsung Biologics plans to commence construction of its fifth plant later this year in response to increased market demand. Upon full completion of the fifth plant in 2025, the company will maintain its global biomanufacturing capacity leadership with a total of 784,000 liters. Continuous strategic investment in antibody-drug conjugates (ADCs) business will be another driver of the company’s growth. Samsung Biologics announced its plan to invest in building an ADC facility within 2024 at this year’s J.P. Morgan Healthcare Conference. The company also invested in Araris Biotech AG through the Samsung Life Science Fund, jointly created with Samsung C&T, to support future advancement of ADC therapies and technology. Samsung Biologics looks to continue momentum with strengthened partnerships worldwide. Further seeking to expand the company’s U.S. presence, Samsung Biologics opened a regional office in New Jersey in March. The new office will enable the company to provide support for clients with greater proximity and agility. Samsung Biologics will remain focused on engaging in sustainable practices by investing in eco-friendly technology throughout its new manufacturing site. Samsung Biologics is also committed to achieving net zero GHG emissions in its operations, moving towards 100% renewable energy by 2050. During the first quarter, the company was recognized by the Carbon Disclosure Project (CDP) for its committed actions and transparent disclosures on climate change. Samsung Biologics was awarded the Sustainable Market Initiative’s Terra Carta Seal in recognition of its commitment to creating sustainable future.
manufacturing and development of new drugs,” said John Rim, President and CEO of Samsung Biologics.“We’re pleased to receive this support from Samsung, as well as the recognition of the potential of our linker-payload toolbox and conjugation technology in such a quickly growing ADC field,” said Philipp Spycher, Ph.D., chief executive officer and co-founder of Araris Biotech. “We look forward to using these proceeds to further support our efforts in advancing our ADC candidates toward the clinic.”
manufacturing. At Samsung Biologics, we use algorithm modeling for near real-time monitoring of column packing quality and sensitive detection of column-integrity breaches, which has enabled us to mitigate risks early on, and in turn deliver consistent product quality and purity during manufacturing.Read more about our specific case studies in this recent whitepaper for BioProcess International here.
manufacturing facility in South Korea, which will be the first plant of the company’s second Bio Campus and its fifth biomanufacturing plant overall. Kevin Sharp, Vice President and Head of Samsung Biologics America–Sales, outlined the expansion at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week. Read more
manufacturing capacity of 180,000 liters, expanding the company’s total site capacity to 784,000 liters upon its completion· Samsung Biologics will invest over KRW 1.9 trillion in the facility, fulfilling its strategic commitment to continuous capacity expansionIncheon, S. Korea, March 17, 2023 – Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), announced today that the company will commence the construction of a fifth plant as part of its strategic expansion in response to increased market demand. The company will invest over KRW 1.9 trillion in the new facility and break ground in the first half of this year with the aim to commence operations in 2025. Located near its current Songdo site, Plant 5 will be the first facility of the company’s second Bio Campus, encompassing an area of 96,000m2 and holding a capacity of 180,000 liters. Upon Plant 5’s full completion, Samsung Biologics will maintain its global biomanufacturing capacity leadership with a total of 784,000 liters. “Given the continuing increase in the demand for outsourced manufacturing of biopharmaceuticals, we are proactively making this investment in alignment with our growth strategy to further strengthen our standing as a leading CDMO,” said John Rim, President and CEO of Samsung Biologics. “The new facility will enable us to provide our customers with even greater innovation and services that will increase speed to market and flexibility.” The plant is expected to further maximize operational efficiency, allowing the company to leverage existing capabilities, expertise and technologies acquired through its experience with Plants 1 through 4, while introducing advanced digitalization and sustainability features. Samsung Biologics purchased 360,000m2 of land in July 2022 for its second Bio Campus, which will house additional large-scale plants and an open innovation center. The company will be investing KRW 7.5 trillion in its second Bio Campus. The company’s existing Plants 1 through 3 are under near-full utilization and its Plant 4, which started partial operations in October last year, is expected to commence full operations by midyear. In line with the company’s expansion plans, Samsung Biologics will also enhance its presence in the U.S. with the opening of a regional office in New Jersey next week. The new office will streamline communication and enable the company to work in closer proximity to clients based in the U.S. and Europe. “Our increased U.S. presence will allow us to provide support for clients with even greater agility and engage the broader biotech industry more than ever,” said Rim. On the same day, the company’s President and CEO John Rim was elected as Chair of the Board of Directors, and will further helm the company’s long-term growth strategy while expanding its leadership position as a top-tier global CDMO.
manufacturing capacity expansion plans in a speaking session during the Member Company Announcement Forum at the event. Already boasting 604,000 liters of biomanufacturing capacity upon the completion of its Plant 4 by midyear, Samsung Biologics is expected to maintain its capacity leadership with the addition of Plant 5 which is planned in its second Bio Campus. The company is also expanding its U.S. presence through opening a new regional office in Ridgefield Park, New Jersey next week as part of the company’s efforts to enable streamlined communication and to work in closer proximity to its clients based in the U.S. and Europe.
manufacturing mRNA vaccines and therapeutics. In this whitepaper, we discuss how Samsung Biologics can provide true end-to-end manufacturing support combined with effective material sourcing and distribution management strategies to accelerate project timelines while reducing risks.
To facilitate accelerated development, drug developers are increasing their outsourcing budget for critical services. In this whitepaper, we discuss what to consider when looking for a trusted CDMO partner and share how Samsung Biologics recognizes the market trends in the biopharma industry and continuously adopts them to serve clients’ needs.
manufacturing.” Samsung Biologics has demonstrated strong business agility with Plants 1, 2 and 3 under full utilization. The company plans to add new capabilities, including an antibody-drug conjugate facility at Plant 4, which is under partial operation and on track for full completion by mid-2023. Upon completion of the latest plant, Samsung Biologics will reaffirm its position as holding the largest biomanufacturing capacity at a single site with 604,000 liters to serve the needs of the clients. “For over a decade, these awards have been the most meaningful for biopharma organizations striving to obtain optimal outcomes from their outsourcing activities. Our research arm, ISR Reports, which only surveys drug sponsors who have worked directly and recently with specific CDMOs, ensures the validity of these results. Our winners are your gold medalists of outsourcing.,” said Louis Garguilo, Chief Editor and Conference Chair at Outsourced Pharma. The CDMO Leadership Awards, now in its 12th year, offers accurate and reliable customer feedback to provide support in choosing a reputable partner for development and manufacturing needs. For this year’s awards, 72 contract manufacturers were assessed by 23 performance metrics as well as their work on an outsourced project within the past 18 months.
manufacturing organization, today announced strong financial results for the fourth quarter and record-high earnings for the fiscal year 2022. "Our steady financial performance in the fourth quarter was driven by solid business growth with strong operational excellence and full utilization across all plants, further accelerated by the full inclusion of Samsung Bioepis in 2022,” said John Rim, CEO and President of Samsung Biologics. “Looking ahead in 2023, we expect the positive business momentum to continue, with the completion and full operation of Plant 4 and construction of our next facility at Bio Campus II. We will also seek to further expand our portfolio by investing in new modalities to diversify our service offerings, and as the world's leading CDMO, we will continue to provide quality-driven services and contribute to saving the lives of patients around the globe." FOURTH QUARTER & FISCAL YEAR 2022 RESULTS The company reported KRW 965.5 billion in consolidated revenue and KRW 312.8 billion in operating profit in the fourth quarter. For the 2022 full-year financial performance, the company posted a record-high consolidated revenue of KRW 3 trillion and KRW 983.6 billion in operating profit. [KRW billion] Q4’22 Q4’21 FY 22 FY 21 Revenues 965.5 444.3 3,001.3 1,568 Operating Profit 312.8 128.8 983.6 537.3 PBT 397.6 109.2 1,009.0 561.3 Net Income 369.9 79.3 798.1 393.6 On a standalone basis, Samsung Biologics recorded a revenue of KRW 2.44 trillion in 2022, an increase of 55% compared to the fiscal year 2021. Operating profit increased to KRW 968.1 billion from KRW 536.5 billion in the previous year. Fourth quarter 2022 revenue was KRW 747.7 billion, an increase of 68% from KRW 444.3 billion reported in the same quarter in the previous year. Operating profit was KRW 308.5 billion, 140% higher year-over-year. Fourth quarter 2022 net profit reached KRW 314.1 billion, an increase of KRW 217.1 billion from the fourth quarter of the preceding year, benefiting from maximized operational efficiency and a favorable foreign exchange rate. FISCAL YEAR 2023 OUTLOOK In line with the company’s three-dimensional growth strategy, Samsung Biologics will continue expansions in capacity, geography, and portfolio in 2023. At the 2023 J.P. Morgan Healthcare Conference in January, the company shared its plan for entering into new business areas - antibody-drug conjugates (ADCs) and cell and gene therapy (CGT) - aiming to become a global top-tier biopharmaceutical company by 2030. Samsung Biologics is planning to build an ADC manufacturing suite in Plant 4 to start production in the first quarter of 2024. The company will also commence construction activities at Bio Campus II on the land it has purchased for KRW 426 billion in 2022, while continuing to invest in promising biotech companies through the Life Science Fund created with Samsung C&T. Samsung Biologics will continue to expand geographically to solidify its foothold in the global market beyond its San Francisco R&D Center, and plans to open new sales offices in Boston and New Jersey, where major big pharma companies are located, to be utilized as key communication portals with global clients. The company has been successful in accelerating the overall construction schedule of Plant 4, which commenced partial operations in October last year, within just 23 months since its groundbreaking. Upon its f
manufacturing, a CDMO partner with the expertise and flexible capacity needed for success in a post-pandemic landscape is crucial. Our expert Eric Hsu, a Lead Specialist in our Alliance Management Group, examines how we can apply the lessons from the pandemic to the biopharma industry in the future. Read more
manufacturing capacity with the full completion of Plant 4 in mid-2023, and invest another 7.5 trillion won in Bio Campus II,” said John Rim, CEO and President of Samsung Biologics. “We are also considering expanding our CDMO services to include antibody-drug conjugate (ADC) and gene therapy.” As part of the company’s global expansion strategy, Rim shared plans to open a new regional office in New Jersey, USA in 2023 to work in close proximity to clients and continue to evaluate expansion to other locations. | Key Strategies for 2023 | ** 604,000L manufacturing capacity upon completion of Plant 4 ** Kickoff plans for Bio Campus II ** Portfolio expansion to ADC, gene therapy; Development of proprietary CDO technology ** Investment in innovative biotech companies through the Life Science Fund ** Opening New Jersey office for better communication with US clients; Evaluate further global expansion Highlighted trends and strategies The J.P. Morgan Healthcare Conference is considered the premier conference where attendees can get a glimpse of upcoming industry trends, with hundreds of companies sharing their achievements and plans for research and development. Samsung Biologics is paying attention to three key trends and plans to implement strategies accordingly based on its three-dimensional growth strategy. · Innovative expansion: Bio and pharmaceutical companies that profited from the pandemic are seeking new growth engines. Some are investing in research and development and incorporating AI technology to develop new drugs, while others are finding ways to add on to their pipelines. Although high interest rates are expected to slow the global economy, cash-rich pharmaceutical companies are expected to actively engage in mergers and acquisitions this year. · Modality diversification: Driven by advancements in life science-related technology, ADC, mRNA, and cell and gene therapy (CGT) are expected to see fast growth. In particular, the global CGT market is expected to grow at a yearly average of 49% to reach $55.6 billion in 2026, from $7.5 billion in 2021, according to research firm Evaluate Pharma. More strategic partnerships with experienced CDMOs are expected due to the rising need in treatments for illnesses that once seemed incurable and as precision medicine becomes a new frontier for healthcare thanks to the diversification in modalities · Sustainable management: Global healthcare organizations are taking joint action against climate change due to the considerable health implications. As the U.S. and Europe strengthen environment-related regulations, sustainable management is no longer an option, but a must. The healthcare industry accounts for around 4-5% of total greenhouse gas emissions (GHG) with more than 50% occurring within the healthcare supply chains. Samsung Biologics has already committed to achieving net zero in GHG emissions in its operations and entire supply chain by 2050 or earlier, and will transition its site to 100% renewable electricity. Together, for the Future Samsung Biologics also used the healthcare conference to engage with existing and new potential clients. The company hosted an exclusive networking reception for key clients to discuss partnerships, as well as meetings with investors and partners. Samsung Biologics plans to further bolster its network and partnerships in the new year to swiftly provide high-quality biopharmaceutical products across the world. We are looking forward to the bright opportunities ahead as we continue to build a healthier and more sustainable tomorrow. We thank everyone who connected with us at this year’s J.P. Morgan Healthcare Conference and look forward to building a meaningful
manufacturing organization (CDMO), was awarded the Sustainable Markets Initiative’s Terra Carta Seal. The Terra Carta Seal, launched at COP26 by His Majesty King Charles III when he was Prince of Wales, recognises global companies that are driving innovation and demonstrating their commitment to, and momentum towards, the creation of genuinely sustainable markets. It is being awarded to companies whose ambitions are aligned with those of the Terra Carta, a recovery plan for Nature, People and Planet, launched in January 2021. Samsung Biologics affirmed its commitment to achieving net zero greenhouse gas emissions across its direct operations and supply chain by 2050 or earlier as part of its global response to climate change. Due to the complex nature of bioprocessing, the company’s environmental management strategy outlines a number of core activities to reduce emissions, including process energy optimization, transitioning to renewable energy by investing in solar panels and utilizing external resources, converting to zero emission vehicles, and minimizing the use of disposables in the manufacturing process through waste management and recycling. Samsung Biologics is also working to drive successful decarbonization by committing to 100% renewable power through the Climate Group’s RE100 initiative and adopting the recommendations of the Task Force on Climate-Related Financial Disclosures (TCFD) in reporting its climate actions progress. John Rim, CEO and President, Samsung Biologics said: “We are honoured to be recognized with the Terra Carta Seal by the Sustainable Markets Initiative for Samsung Biologics’ contribution in working alongside our industry peers for this global effort. Healthcare is at a pivotal moment and through our collaborative efforts, we can contribute to shaping climate-resilient practices to influence and help shape policy across the pharmaceutical and healthcare sectors.” Brian Moynihan, Co-Chair, Sustainable Markets Initiative said: “The SMI brings CEOs together to work on the shared goals of accelerating our transition to a sustainable future. I congratulate those organizations recognized with the 2022 Terra Carta Seal and thank them for their commitment to sustainable markets.” The Terra Carta Seal acknowledges that each industry faces unique challenges in its transition to a sustainable future and they are all at different stages of their journey. And all industries and companies must be supported as they take steps in a more positive direction. At the same time, an accelerated pace is required if we are to achieve a 1.5-degree target, protect and restore biodiversity and benefit the lives and livelihoods of current and future generations. Alongside its work to eliminate carbon emissions from its own operations, Samsung Biologics is engaging its suppliers as part of a broader initiative by the Supply Chains Working Group within the Sustainable Markets Initiative’s Health Systems Task Force to reduce direct emissions and identify carbon reduction options with the goal of reaching net zero in its supply chain. Last month, the Task Force announced joint action at COP27 to achieve near-term emissions reduction targets and published commitments to decarbonize through a series of whitepapers outlining practical recommendations and scalable actions for health systems stakeholders. Sir Jony Ive and his creative team at LoveFrom created a physical and animated seal engineered with paper that is both simple and beautifully crafted. The design combines a host of natural references including oak leaves, fern, magnolia and honeybees and intricate patterns both in nature and in the arts, creating a visual celebration which reflects the power of and reverence for nature that is at the heart of the Terra Carta. For more details and continuous updates on sustainability activities, please visit the Samsung Biologics’ Sustainability page.
manufacturing plant will drive clients’ success Company News Samsung Biologics to purchase land for its second Bio Campus Driven. For ADVANCED TECHNOLOGY. Samsung BIO Insight The Power of One | Samsung Biologics’ mRNA Capabilities Samsung BIO Insight Exploring Samsung Biologics’ CDO capabilities | Bispecific antibodies Driven. For A SUSTAINABLE LIFE. Samsung BIO Insight Strategies for a Sustainable Future - Interview with John Rim, CEO and President of Samsung Biologics Media Focus Seven pharma CEOs announce new joint action to accelerate net zero healthcare
manufacturing, it has a competitive edge in new drug development, where speed is crucial. Samsung Biologics has received over 160 regulatory approvals as of October 2022. The company has also strengthened its foothold as a new drug development partner by establishing a one-stop service from cell line development to commercial manufacturing, and opened an CDO R&D Center in San Francisco to provide services in close proximity to clients. To meet fast-changing industry trends, Samsung also launched DEVELOPICK™, a developability assessment platform that screens molecules at an early stage to identify candidates with the best potential for advancement to Investigational New Drug, alongside the S-DUAL™. Samsung Biologics will continue to invest and take action to lead in the next-generation of biopharmaceuticals. Related Content Whitepapers Fundamental Considerations for Bispecific Antibody-based Cell Line Development Samsung BIO Insight BioProcess International 2022 | Samsung Biologics unveils new development platforms to offer differentiated services
A novel technology, mRNA has the potential to broaden treatment options for many diseases and disorders. As mRNA becomes a major focus of drug development, it is necessary to partner with a one-stop CDMO to eliminate the increased risk associated with multiple tech transfers, as well as the added time and cost. In this whitepaper, Esther Yoo, Head of Development Sales, offers insights on how Samsung has been exploring the possibilities of mRNA since before the pandemic and is now leveraging this expertise.
manufacturing process through waste management, while disclosing risks and opportunities through the Carbon Disclosure Project (CDP). Samsung Biologics is also engaging its suppliers and partners to drive successful decarbonization throughout the supply chains in a number of global initiatives such as Frontier 1.5D and the Sustainable Markets Initiative. The company has also conducted various social contribution activities to develop the local community. In partnership with the Incheon Human Resources Development Foundation, Samsung Biologics created a youth scholarship and mentoring program to provide financial support and career counseling to underprivileged students. It also started a medical expense aid in 2013 to support medical expenses for disadvantaged patients at local Incheon hospitals. Samsung Biologics also strengthened its corporate transparency by ensuring compliance with laws and ethics is a top management principle. Last year, it established an ESG committee under its Board of Directors as well as an internal accounting evaluation group under its Audit committee. Its robust Business Continuity Management System (BCMS) helps increase organizational resilience and assimilates business continuity awareness and activities into its general operations. The company also minimizes potential risks and strengthens responsibility towards human rights, health and the environment through prevention training, rigorous reporting and monitoring, and follow-up management. For more details and continuous updates on sustainability activities, please visit the Sustainability page.
manufacturing capacity at Samsung Biologics, as well as the new mRNA business. We emphasized our end-to-end service capability through introducing the newly launched CDO platform services – S-DUAL™ bispecific antibody platform, and DEVELOPICK™ developability assessment platform,” said Grace Chung from Global Sales at Samsung Biologics. On the first day of the conference, Kevin Sharp, VP of Global Sales at Samsung Biologics, presented under the topic – What are the key considerations in choosing the right CDMO partner? “The demand for biomedicines is forecasted to exceed supply by 2026,” he said. “As a lot of investment and time are required to mass-produce biomedicines on time, a strategic partnership with an industry-proven CDMO like Samsung Biologics would help global biotech companies to run businesses more efficiently and put more concentrated efforts into developing new, innovative medicines.” While emphasizing the company’s overall capability differentiated from others, he also stressed that Samsung Biologics has built the world’s largest biomedicine production facility and earned more than 160 global regulatory approvals at speed with reliability across every business platform. On day two, James Choi, EVP and Chief Information and Marketing Officer at Samsung Biologics, laid out a ESG initiative at Samsung Biologics in a session titled – Partnering with CDMOs for a Sustainable Future. “The biopharmaceutical industry is responsible of about 4 to 5% of global greenhouse gas emissions released into the air, and about half of those emissions come from supply chain operations,” said Choi, emphasizing why a strategic partnership with a sustainable CDMO has become imperative for a biotech company to establish a sustainable business model. Client-tailored contents and eventsMeanwhile, Samsung Biologics’ vibrant booth grabbed conference-goers’ attention with a large display allowing visitors to watch and easily learn the company’s innovative work and accomplishment at a glance.The company’s capabilities in CMO, CDO and ESG management were each displayed on individual wall graphics, and vigorous marketing activities, including a digital surveys, happy hour and lucky draw events, were carried out throughout the conference. Samsung Biologics’ aim to create a sustainable future“Sustainability is definitely a rising trend within the biopharmaceutical industry,” said a CPHI conference organizer. “That’s why CPHI Worldwide 2022 created a sustainability theater for the first time in the conference history.” The organizer also added that the CPHI conference is looking to support the industry to responsibly advance for a greener future by sharing model episodes and providing networking opportunities for global companies to build a sustainable partnership. In addition to Sustainability, Digitalization was also featured as a keyword at the conference this year.CPHI Worldwide 2022 closed on a very high note this year, with great turnouts from the growing industry. As a leading CDMO, Samsung Biologics will continue to tread on to build a healthier, sustainable future, accelerating excellence. Related Contents Samsung BIO Insight Samsung Biologics’ Super Plant 4, How the world’s largest biomanufacturing plant will drive clients’ successSamsung BIO Insight Unlocking the Possibilities to the Future of Biopharma | 2022 BIO International ConventionSamsung BIO Insight BioProcess International 2022 | Samsung Biologics unveils new development platforms to offer differentiated services
manufacturing capacity, the company plans to maximize operational efficiency for its clients and further strengthen its foothold in the industry as an end-to-end service partner. Breaking world records In just 23 months since its groundbreaking in November 2020, Samsung Biologics delivered on its commitment to begin partial operations at Plant 4. As the world’s largest single biomanufacturing plant, Plant 4 is expected to have a production capacity of 240,000 liters upon full completion next year, giving Samsung Biologics a total of 604,000 liters’ capacity, amounting to over a quarter of the total global CDMO production, at Bio Campus I. Plant 4 groundbreaking ceremony (Nov. 2020) Samsung Biologics’ total manufacturing capacity Samsung Biologics offers end-to-end services, from early stage development to commercial manufacturing, including quality management. The company also has a diverse lineup of bioreactors, from 1,000 liters to 15,000 liters, enabling flexibility for small batch clinical trial materials production or large-scale commercial manufacturing. Samsung Biologics can swiftly and efficiently manufacture high-quality biopharmaceuticals based on N-1 perfusion technology, data digitalization and cyber security integrity. Plant 4 incorporates the know-how, technologies and best practices learned at Plants 1, 2 and 3. Investing in a sustainable tomorrow As a sustainable CDMO, Samsung Biologics invested in eco-friendly technology throughout Plant 4 to mitigate its emissions. A 1,300 kW solar power generator was installed on the plant’s roof over an area of 4,000㎡ to partially generate energy for the plant. In order to reduce direct GHG emissions, the company adopted the ‘Factory Energy Management System,’ to monitor and analyze energy consumption to help reduce emissions and waste. Through its environmental management strategy, the company plans to take additional measures going forward to enhance its recycling process when it comes to disposables and water use, reduce energy consumption by switching to high-efficiency boilers, and prevent air pollution to help tackle climate change. Solar panels installed on Plant 4 Accelerating excellence Plant 4 can handle a product’s entire production life cycle within a single site. It will also be equipped with multiple digital solutions to achieve data integrity and transparency, while eliminating the potential of human error. Samsung Biologics plans to further boost client satisfaction through continuous innovation and investments, as well as the construction of Bio Campus II, which will host Plants 5 through 8. Samsung Biologics will continue to accelerate excellence for a healthier future and bolster its standing as a leading CDMO by expanding its capacity, portfolio and global presence. Opening ceremony of Plant 4 (Oct. 2022) Related ContentYouTube The Future of Biopharma: Plant 4YouTube Samsung Biologics Plant 4: Specs & Features
manufacturing organization, released today its fiscal year 2022 third-quarter financial results, announcing that the company’s cumulative revenue in fiscal year 2022 surpassed KRW 2 trillion. John Rim, CEO of Samsung Biologics, said: “This past quarter saw strong performance and growth due to a consistent momentum in signing new contracts, helping us meet client demand for integrated offerings and deliver long-term value. Not only have we delivered on our commitments by commencing GMP operations of Plant 4 within just 23 months from the start of its construction, we have also developed and launched our next-generation bio-technologies – S-DUAL™ and DEVELOPICK™ – which will help streamline and accelerate the antibody development process to save time and cost for our clients.” THIRD QUARTER 2022 RESULTSSamsung Biologics in the third fiscal quarter recorded a consolidated revenue of KRW 873 billion, operating profit of KRW 324.7 billion, and net profit of KRW 129.2 billion. [Consolidated Earnings Results] Q3’22 Q3’21 YoY Change Q2’22 QoQ Revenues 873 450.7 +422.3 651.4 +221.6 Operating Profit 324.7 167.4 +157.3 169.7 +155 Net Profit 129.2 131.8 -2.6 152 -22.8 [Unit: KRW billion] FOURTH QUARTER & FISCAL YEAR 2022 OUTLOOK As previously announced, Samsung Biologics commenced GMP operations of Plant 4, the world’s largest single bio-manufacturing plant, within just 23 months since its groundbreaking. The construction of the 240,000-liter CDMO plant is expected to be completed in 2023, designating Samsung Biologics as the top global manufacturing hub with a total capacity of 604,000 liters, a volume equivalent to over one-fourth of worldwide CMO capacity. Samsung Biologics launched its new proprietary development technology platforms – S-DUAL™ and DEVELOPICK™ – a high-yield bispecific antibody platform and a rapid developability assessment platform. Samsung Biologics also achieved several business milestones, including the signing of a land-purchasing agreement for Bio Campus II with 30% greater land area for additional capacity and platform growth. Then in August, a $15 million investment through the Samsung Life Science Fund, a joint venture with Samsung C&T, was granted to Senda Biosciences, a U.S.-based biotechnology company committed to fostering core technologies needed to develop next-generation biopharmaceuticals. In September, Samsung Biologics received EcoVadis’ Gold Sustainability Rating in recognition of its ongoing sustainable management efforts, placing the company within the top 5 percentile. For more details on performance and financials, please refer to the Earnings Release.
manufacturing organization (CDMO), announced today it has successfully renewed its ISO 27001 certification (Information Security Management System) and obtained ISO 27017 certification (Information Security in cloud services) and ISO 37001 certification (Anti-bribery management systems). An award ceremony was held with the British Standards Institution (BSI) and the British Embassy Seoul at Samsung Biologics’ Songdo headquarters. Samsung Biologics is the first global CDMO to concurrently obtain two international certifications for information security. The company first obtained ISO 27001 certification in 2019. With the additional cloud-specific ISO 27017, the certifications demonstrate Samsung Biologics’ measures to meet strict global security standards and proactively protect information entrusted by its clients. As part of the business process, a contract manufacturer receives critical and sensitive data from clients, making security even more critical. The ISO 37001 certification, another first for the company, is further demonstration of the company’s reliability and integrity in mitigating bribery risks and meeting legislative requirements based on its anti-bribery management system. “We are extremely proud to add the additional global ISO certifications,” said John Rim, CEO and President of Samsung Biologics. “These latest certifications are in show of our commitment to meet the strongest security standards and our dedication to further enhance client trust and satisfaction.” Samsung Biologics also received the Excellence Award for Integrated Management System from BSI, which is awarded to companies that have made outstanding business performance based on international regulations. Samsung Biologics currently maintains eight ISO certifications, including ISO 14001 (Environmental management systems), ISO 22301 (Business continuity management system), ISO 45001 (Occupational health and safety management system), ISO 50001 (Energy management system) and ISO 9001 (Quality management system).
manufacturing capacity of 60,000 liters • Plant 4’s total capacity of 240,000 liters to be ready early next year Incheon, S. Korea, October 11, 2022 – Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), announced today that its Plant 4 – the world’s largest single bio manufacturing plant – has commenced GMP operations this month.Plant 4’s partial operations comes just 23 months after construction began in November 2020, adding fresh production capacity of 60,000 liters. Plant 4 will have a total capacity of 240,000 liters when it becomes fully completed in the first half of next year.Plant 4 is expected to help Samsung Biologics maximize operational efficiency in addition to further enhancing its scale up development and manufacturing capability in response to growing biopharmaceutical demand.“At the P4 groundbreaking ceremony in late 2020, we committed to have the plant up and running by October this year. I am very proud to have delivered on that promise, and confident that this will further solidify our position as a global leading CDMO,” said John Rim, CEO and President of Samsung Biologics. “As a trusted partner, we will continue investing domestically and globally to support our clients worldwide and provide expanded services.”Upon the full completion of Plant 4, Samsung Biologics will boast a total capacity of 604,000 liters at Bio Campus I, the world’s largest bio manufacturing site, and account for nearly 30% of the global CDMO manufacturing capacity. Samsung Biologics has already sealed a number of large-scale manufacturing contracts with presales activities for Plant 4. The company has also acquired additional land for Bio Campus II, which will host Plants 5 through 8, as well as an Open Innovation Center. Construction is set to begin later this year and will be 30% larger in size compared to Bio Campus I.
Manufacturing Science and Technology) capabilities during the three-day event to showcase the company’s competency in the contract development business. Solidifying Global Foothold as a Partner for Successful Development of New Drugs Samsung Biologics has won over 100 projects since it first launched its CDO business in 2018. It offers end-to-end, one-stop services, from cell line development to integrated manufacturing from clinical to commercial, enabling cost and time reduction for development. Samsung Biologics continues to strengthen its foothold in the global contract development market, by opening an R&D Center in San Francisco in 2020, launching its proprietary cell line, S-CHOice® in 2021, and the ‘S-DUALTM’ and ‘DEVELOPICKTM’ this year. Samsung Biologics will continue innovating for the successful development of new drugs and the production of high-quality biopharmaceuticals for clients. Related Contents Press Release Samsung Biologics introduces new development platforms S-DUAL™ and DEVELOPICK™ at BPI Boston 2022 Samsung BIO Insight The Value of Reducing Your Drug Development TimelineSamsung BIO Insight The Journey to Your Success | Explore Samsung Biologics' CDO Strengths
manufacturing organization (CDMO), is launching its new proprietary development technology platforms – S-DUAL™ and DEVELOPICK™ – at this year’s BioProcess International Conference and Exhibition in Boston.S-DUAL™ is a high-yield bispecific antibody platform with a 99% chain-pairing success rate. Its unique asymmetrical structure reduces risks associated with chemistry, manufacturing and control (CMC), and thus ensures high binding affinity among chains to produce high titer and purity for optimized manufacturability. DEVELOPICK™ is a rapid developability assessment platform that systematically screens molecules at an early development stage to identify candidates with the best potential for advancement to Investigational New Drug (IND) and Biological License Application (BLA). Requiring only 20 milligrams of material, the assessment platform enables clients to conduct a robust risk assessment for unsorted drug candidates within a month, guiding them to the path of biotherapeutic development success. “We are excited to showcase our innovative platforms at the BioProcess International Conference this week,” said John Rim, CEO of Samsung Biologics. “Through these new development technologies, we provide early insight and ensure higher yield of molecules, ultimately enabling clients to reach commercialization much more efficiently.”Samsung Biologics is also hosting a speaking session to discuss its new approach to bispecific antibody development and has presented scientific posters on a number of topics throughout the event. To find out more, get in touch with a representative at Booth #837 or through the website at samsungbiologics.com.
manufacturing organization (CDMO), was awarded the Gold Sustainability Rating from EcoVadis, a leading global business provider that evaluates the Corporate Social Responsibility (CSR) performances of companies in areas related to environment, labor and human rights, ethics and sustainable procurement. Achieving a score of 71/100—14 points higher than its previous Silver rating in 2021—Samsung Biologics is now among the top 5% of the more than 100,000 companies worldwide assessed by EcoVadis. “Achieving an EcoVadis Gold rating is further indication of Samsung Biologics’ strengthened ESG focus and our commitment to working with our suppliers and industry partners to reduce our environmental impact, integrate sustainable management, and build a more transparent, responsible value chain,” said John Rim, CEO and President of Samsung Biologics. “Not only is prioritizing these efforts within our business the right thing to do, but it is also an important part of what we bring to our clients to help them meet their own sustainability commitments.” The company recently published its annual ESG report, disclosing its environmental management strategy that outlines a number of core activities to reduce emissions, including process energy optimization, transitioning to renewable energy, and minimizing the use of disposables in the manufacturing process through waste management and recycling. Responsible procurement is also another key element in the company’s sustainability strategy. Samsung Biologics’ Supplier Code of Conduct was amended in February in accordance with the Responsible Business Alliance (RBA) and Pharmaceutical Supply Chain Initiative (PSCI), emphasizing its heightened focus on achieving a sustainable supply chain. For more details and continuous updates on sustainability activities, please visit Samsung Biologics’ Sustainability page.
manufacturing, the drug product process requires scrupulous control and maintenance, attention to quality and extensive expertise for a successful clinical or commercial launch. Companies that do not have a reliable process in place could face challenges, costing time and money. At Samsung Biologics, we employ state-of-the-art technologies to make and deliver flawless drug products to our clients. Below is an in-depth look at how we manufacture these products at our headquarters in Songdo, South Korea. What is a Drug Product? Biomedicine is categorized into two elements: Drug Substance (DS) and Drug Product (DP). Drug substance, an ingredient used for producing DPs, is a material generated via either synthesis, fermentation or extraction, or a combination of these three methods. For instance, extracted antibodies through cell culture and purification processes are considered drug substances. These substances then get transformed into a dosage form called drug product — which, after being aseptically filled into either a vial, cartridge or syringe, gets safely injected into a patient’s body. How is a Drug Product Manufactured? Samsung Biologics manufactures drug products by using drug substances manufactured at its own site or delivered from clients. Drug Product Manufacturing Stages > Formulation: First, scientists will integrate the characterization of client molecule with the final product format, developing a formulation that will ensure the delivery of a stable product. Depending on characteristics of substances, buffers are utilized in this stage to maintain safety.> Aseptic Filling: Once formulated, substances – in either a liquid or lyophilized form – get filled into a container such as a vial, pre-filled syringe or cartridge. If needed, a filling conducted in a lyophilized form adds maximum stability to biomedicines as lyophilization eliminates any remaining liquid or moisture inside the container.> Inspection: After being filled, biomedicines undergo a series of inspections to confirm they meet compliance and thus are safe for bodily injection.> Labeling and Packaging: And finally, drug products get labeled and packaged for shipment. Client-Optimized, End-to-End Solution Samsung Biologics provides a one-stop, end-to-end solution that consists of aseptic filling, visual inspection, labeling and packaging, release testing and regulatory support. To ensure flawless quality of drug products manufactured and delivered to clients across continents, Samsung Biologics may utilize stainless steel or a single-use system not only to accommodate distinctive manufacturing preferences from clients but also to ensure the quality of the drug product. Samsung Biologics’ Fill-Finish manufacturing capabilities The company has for years managed to meet the needs of its biopharma clients, both big and small, as it not only operates batches sized from 5L to 2,500L but also employs a small-scale clinical Flexible Filling Line (FFL). With the world’s largest CMO capacity, Samsung Biologics’ fully integrated drug substance and drug product manufacturing can help clients save operational time and cost. Additionally, the company employs a dedicated, expert MSAT team to efficiently execute optimization of process technology from the tech transfer stage. Furthermore, a thorough maintenance at the manufacturing stage is conducted to produce high-quality biomedicines as well as regulatory support in the subsequent stages for the sake of clients. Drug products must be rigorously inspected for their safety and effectiveness as they get directly injected into patients. Samsung Biologics has earned more than 63 drug product manufacturing approvals from global regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicine Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency. Preparing for a Healthier Future with Samsung Biologics Drug substances and products make up about 57% and 43%, res
manufacturing equipment and process optimization play a significant role in increasing speed to market of critical biologic drugs. In this article, Youlim Kim, our Lead Scientist in Cell Line Development, explores the challenges associated with CLD and offers an expert look into the tactics CDMOs can employ to shorten commercial timelines while preserving quality and yield. Learn more (See page 44-45)
Manufacturing Companies (CDMO)• Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product Boston and Incheon, S. Korea, August 1, 2022—GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA production partnership. Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung’s commercial facility was completed in seven months, demonstrating platform adaptability and scalability. GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA. The company’s RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight’s Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale. “This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and President at Samsung Biologics. Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients. “One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.” To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale.
manufacturing organization, today announced strong financial results for the second quarter of fiscal year 2022. John Rim, CEO of Samsung Biologics, stated, “Samsung Biologics delivered another strong quarterly performance ahead of our guidance with our revenue exceeding KRW 1 trillion for the first half of the year. Operations are seamless across all our plants, and the partial completion of Plant 4 is just around the corner, scheduled to commence operations in October this year. We completed a deal to fully acquire Samsung Bioepis, expanding and diversifying our revenue base and business portfolio. More recently, we have officially signed an agreement to purchase land for Bio campus II. All these factors signal that we have a strong momentum going, and that we are well on track in our expansion plans to serve the increasing market demands.” SECOND QUARTER 2022 RESULTS Samsung Biologics demonstrated strong operational excellence and business agility in the second quarter with earnings exceeding initial projections. Reporting under the consolidated approach for the first time since the acquisition in April, Samsung Biologics and Samsung Bioepis in the second fiscal quarter recorded a revenue of KRW 651.4 billion, operating profit of KRW 169.7 billion, and net profit of KRW 152 billion with EBITDA margin of 39.7%. On a standalone basis, the second quarter 2022 revenue for Samsung Biologics was KRW 503.7 billion, an increase of 22.2% from KRW 412.2 billion reported for the second quarter in the previous year, due to efficiency in operations despite a scheduled slow-down of Plant 2, and attributable to the expansion of product sales. Samsung Biologics also reported an operating profit of KRW 171.9 billion, 3.18% higher than the prior-year period, and a net profit of KRW 101.8 billion with an operating profit margin of 34.1% for the same quarter. On a standalone basis, Samsung Bioepis earned KRW 232.8 billion in revenue, 24.2% higher than the prior-year period attributable to the increase in sales of its biosimilar products in global markets including the US and Europe. Samsung Bioepis’s operating profit increased significantly by 95.7% compared to the prior-year period, at KRW 58.5 billion. FISCAL YEAR 2022 OUTLOOK The construction of Samsung Biologics Plant 4 is on schedule with 6 X 10KL production capacity expected to commence operations in October. The company has secured a number of large scale manufacturing contracts with active presales activities for Plant 4, and at the close of Q2, in the first half of 2022 alone, the company had secured over USD 7.9 billion in sales backlog including deals with Janssen, Merck, GSK, Lilly, and Novartis to name a few. Earlier this month, Samsung Biologics secured additional land sized at 357,366 ㎡ and approximately 30% larger than its current site, to support the build out of its second campus. At the newly acquired site, the company will host additional large-scale manufacturing facilities as well as an open innovation facility. Samsung Biologics also published its second annual ESG Report this month, reflecting the company’s latest sustainability efforts to address a wide range of environmental, social, and governance (ESG) activities related to its business. The company aims to build an eco-friendly business environment and achieve net zero GHG emissions in its operations, and continue to enhance its social contribution activities that strive to support the health of its local communities. Samsung Bioepis has a total of six biosimilar products approved and commercially available in different markets , and its revenue has steadily grown driven by increases in global product sales and milestone payments. Of the six products, SB4, a biosimilar to Enbrel (etanercept), which was launched in Europe in 2016, has surpassed its originator’s sales in Europe by overtaking the majority of the market share, and the company recently launched SB11, a biosimilar to Lucentis (ranibizumab), in June 20
manufacturing campus in South Korea Samsung’s expansion plan for its CDMO unit is an efficient, no-nonsense enterprise, marching on with no end in sight.Maybe that’s why, at its home base in South Korea, Samsung Biologics refers to its factories by number. none; border: 0px; vertical-align: baseline; color: rgb(0, 117, 200);">Read more
manufacturing capacities Incheon, S. Korea, July 18 2022 – Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization (CDMO), announced that it has signed a land purchase agreement with the Incheon Free Economic Zone(IFEZ) on July 18th to support the build out of its second Bio Campus. The additionally acquired land is located within Songdo Industrial Cluster, covering an area of 357,366 square meters which is 30% larger than the company’s current campus. Bio Campus II is designed to support Samsung Biologics’ further expansion of large-scale manufacturing capacity as well as host a multi-modal plant and an open innovation facility. The land purchase was valued at KRW 426 billion. The land was awarded to Samsung Biologics in accordance with the IFEZ’s strategy to strengthen the region’s global competitiveness in the biopharma sector while fostering partnerships with small and mid-sized venture companies. As a result of this deal, 4,000 additional jobs are expected to be generated by 2032 when the project is complete. “This milestone further solidifies our roadmap to build a world-class global bio-hub at the heart of Songdo,” said John Rim, CEO and President of Samsung Biologics. “Through continuous investment, we will maintain our position as the best-in-class CDMO partner, fully equipped with the world's largest manufacturing capacity and provide diverse service offerings to our clients to address new emerging diseases and save lives of patients worldwide.” “Samsung Biologics’ achievements over the past decade are remarkable and highly impressive,” said Jeong Bok Yoo, Mayor of Incheon Metropolitan City. “The city will do its best to support the development of the bio industry’s infrastructure and further drive Songdo to become a global bio hub.” Samsung Biologics’ Plant 4 is currently under stable construction to begin partial operations by October 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.
manufacturing organization, today published its second annual ESG Report, reflecting the company’s sustainability efforts in 2021 to address a wide range of environmental, social, and governance (ESG) activities related to its business. The report also provides increased transparency on its approach and achievements in the following areas: reduction of greenhouse gas (GHG) emissions, enhanced social contribution activities, and evaluations in the Board of Directors’ structure. John Rim, President and CEO of Samsung Biologics, said: “Under our ‘Driven. For a Sustainable Life.’ framework, we are continuously improving and committing our resources to create a sustainable environment, build a healthy society, and implement responsible business activities. The publication of our annual ESG Report reinforces the progress we’ve made, while keeping us focused on the long-term goals we’ve set. Our sustainability initiatives reinforce the connection between the work we do and how we fulfill our mission, while delivering on our core values of always putting people and the environment first.” This year’s report highlights the company’s progress in reducing Scope 1 and 2 emissions by 32.3% compared to the previous year, and its commitment to reduce total Scope 1 and 2 emissions 54.3% and Scope 3 emissions 25.7% by 2026, compared to 2021. The company is also actively working to engage its suppliers to transition to net zero emissions in multiple areas and invest in renewable energy. Samsung Biologics’ commitment to addressing the most critical issues facing the planet is underscored by a series of global initiatives and projects to deliver progress related to climate change. Significant milestones include:• To accelerate the delivery of net zero, sustainable healthcare to improve individual, societal, and planetary health, Samsung Biologics is actively involved in the Health Systems Taskforce as part of His Royal Highness The Prince of Wales’ Sustainable Markets Initiative, alongside global leaders from across the healthcare system, academia, and international organizations like the WHO and UNICEF. • To foster collaborative solutions, Samsung Biologics also announced its participation in the 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 the Carbon Disclosure Project (CDP), Samsung Biologics, as a business sector representative, 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. Using Pricewaterhouse Coopers’ Total Impact Measurement and Management methodology as a guiding principle, Samsung Biologics has contributed 1.6 trillion Korean won in economic and social value creation. The company detailed its social contribution activities to provide youth education and scholarship support, equitable access to quality and affordable healthcare services, and childcare support. In joint partnership with other Samsung affiliates, the company has introduced new programs like Dream Class to provide career counseling for middle school students in low-income families and the Stepping Stone of Hope project to offer self-sufficiency training and support for at-risk youth. The company is also supporting ESG activities of its partner companies and requiring suppliers to comply with the company’s Supplier Code of Conduct, which was amended this February in accordance with the Responsible Business Alliance (RBA) and Pharmaceutical Supply Chain Initiative (PSCI). Through these activities, Samsung Biologics aims to reduce ESG risk in its supply chain and build a stable network of partners. As noted in the report, the company established increased independence and transparency in its Board structure by separating the Chair and CEO positions, a
Manufacturing Center, participated in a panel session to address key insights into mRNA and give guidance on what to look for in a CDMO partner. During the session, Catignol introduced the unique capabilities of Samsung Biologics and how it offers fully integrated mRNA manufacturing services all at a single site in Songdo. Limitless Together to Bring New Opportunities “BIO International is a place where bio-industry professionals and experts can come together to explore ways to cooperate and create new opportunities. This year’s theme of ‘Limitless Together’ is to show the cross-boundary collaboration of bio officials and the unlimited challenges in unknown areas,” said Adela Wilson from BIO. “Samsung Biologics’ performance was remarkable, both with its creative booth design and outstanding service competitiveness.” Samsung Biologics is at the forefront of building a sustainable future for all. By leveraging its world’s largest manufacturing capacity and continuous innovation, the company will strive to make innovative biologics accessible to all and create a healthier future. Driven. For Life. Related ContentsSamsung BIO Insight The Power of One I Samsung Biologics’ mRNA CapabilitiesLife @ Samsung Biologics Driven. For Climate Action
manufacturing of Moderna’s COVID-19 vaccine last year, Samsung Biologics has also added
messenger RNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo in
April this year. This has driven the company to successfully venture into offering this new
In this article, we will explore what mRNA technology is and the unique capabilities Samsung Biologics
RNA carries the ‘blueprint’ instructions to produce proteins
Messenger RNA (mRNA) is a type of
single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and it is made from a
DNA template during the process of transcription. The role of mRNA is to carry protein information from the
DNA in a cell’s nucleus to the sites of protein synthesis in the ribosomes to help make a specific protein.
The ribosomes “translate” the instructions in mRNA and synthesize the protein.
A ribosome is an intercellular structure found inside the living cells which reads the messenger RNA (mRNA)
sequence and translates that genetic code into a specified string of amino acids to produce proteins during
a process called protein synthesis.
Promising opportunities for
mRNA is revolutionizing the way we prevent,
treat, and cure diseases, and it is opening up new ways to treat debilitating diseases such as cancer and
The biggest advantages of mRNA are its
flexibility to adapt to an evolving pathogen and the potential for rapid, cost-effective, and scalable
manufacturing. Most mRNA-based therapeutics are currently being used against infectious diseases or to
develop personalized vaccines.
Understanding mRNA COVID-19
Most vaccines put a weakened or inactivated
germ into our bodies to stimulate an immune response. However, mRNA vaccines against COVID-19 are designed
to provide our bodies with the code to produce the non-infectious virus spike protein to instruct the cell’s
machinery to help trigger a natural immune response.
This response is enabled by the production of
neutralizing antibodies which aims to prevent the infection. If a vaccinated person later comes into contact
with the COVID-19 virus, the immune system will recognize the virus as an ‘intruder’ and enable the body to
fight the virus.
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 efficiency and data integrity through the appropriate use of digital technologies" James Choi EVP, Chief Information and Marketing Officer How can the biopharma industry accelerate its digitalization journey more effectively? In this article, James Choi, our EVP and Chief Information and Marketing Officer, shares that by adopting a ‘simplify, optimize, automate, and outsource (SOAO)’ method, biopharmas can build a strong foundation of optimized processes to help achieve a smooth digital transformation. Read more
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 firstname.lastname@example.org 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-Champaign) 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-Champaign) 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-Champaign) 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 CAPACITY Multiscale capacity providing end-to-end service offerings with flexibility with utmost speed and cost-effectiveness Expertise ONE DEDICATED TEAM A dedicated team to quickly drive your Projects to completion from early development through clinical and commercial manufacturing Fast-track your pipeline with us to augment your capacity and expertise, refind your processes, and ultimately shorten your time to market Related contents Samsung BIO Insight The Benefit of Speed, Scale & Quality | Explore Samsung Biologics' CMO StrengthsSamsung BIO Insight Advance Your Molecule to Success with a True End-to-End Partner Whitepapers Redefining Speed In Drug Development : Samsung Biologics' S-Cellerate™ Platform
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 2022 What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.Read MoreAll rights are reserved by the media that published this article.
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 Key achievements of 2021 Achievements of 2021 Accumulated a total of 61 CMO contracts(As of thira quarter of 2021) Launched CDO process platform, S-CellerateTM (Offering expedited process for the development and commercialization of monoclonal antibodies) Marked record-high financial results(Accumulative revenue of KRW 1.24 trillion and operating profit of KRW 408.5 billion as of third quarter of 2021) Expanded mRNA services offerings(Signing mRNA DP contract, adding mRNA DS manufacturing suite, and securing additional land for the building of MMP) Launched ESG management system(lssuing first annual sustainability report, joining DOW jonse Sustainability World index(DJSI), participating in Sustainable Markets Initiative Task Force) *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 Expanded manufacturing capacity Plant 1(30,000L) Plant 2(154,000L) Plant 3(180,000L) Plant 4(256,000L) ● Plant 4 partially operational (Q4 2022) ● Secure additional sites within Songdo for Bio Campus II 2) Advancements in business portfolio Advancements in business portfolio mAb/Fusion Protein Cell/Gene Therapy Vaccine, Viral Vector mRNA mAb/Fusion Protein + Open Innovation ● 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 Conference News Brief JP Morgan Healthcare Conference (Audio Link) YouTube The Future of BioPharma: Plant 4 ESG Sustainability Report 2021
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
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.
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