development and manufacturing. Our recent webinar features Mark Thompson, Associate Director of CDO Sales, who shares insights on how Samsung Biologics’ expanded development labs and integrated platforms help streamline the path from sequence to IND.

development stage. With a proven track record and continuous commitment to setting the pace, Samsung Biologics focuses on addressing client needs to align with the global demand for reliable therapeutic supplies.Designed to serve clients’ evolving needsAs new product launches often entail novel processes, legacy facilities may be constrained in adapting to the evolving needs of modern biomanufacturing. While Plant 5 follows a standardized design intended to serve as a future guide, it integrates innovative infrastructure to support both established and next-generation processes with agility and efficiency.The core technologies, such as N-1 perfusion and Raman spectroscopy, along with advancements in digitalization, including computational fluid dynamics and digital twin technology, enable real-time data monitoring for clients. While these systems have already been standardized and implemented to form a strong foundation, Samsung Biologics goes further to pursue a facility design that prioritizes flexibility, allowing for the smooth incorporation of emerging technologies.Equipping clients with operational excellenceOne example of Samsung Biologics’ commitment to continuous improvement is logistics automation. Enhanced confidence in quality, which stems from the automation of once-manual procedures, contributes to robust manufacturing. Plant 4 started automating its storage and retrieval system in 2022; Plant 5 now applies end-to-end logistics automation across the entire site.“If Bio Campus I was about automated storage, Bio Campus II would be about automated plants,” said Changgeun Lee, Associate Director of Plant 5 Logistics. Automation efforts, such as autonomous mobile robots (AMRs) in the central manufacturing support (MS) building on Bio Campus II, permeate the company.The central MS building features a main spine bridge that acts as a linear highway, which will increase work efficiency by 50% upon campus completion. Separate routes are allocated for people and AMRs, which are programmed to transport supplies and samples to target locations, streamlining movement and ensuring employee safety.Transparency in storage is made possible by real-time monitoring of supply and sample transportation. Multiple sensors in the storage system, for example, help prevent the fall or collision of materials and ensure supply quality while keeping the manufacturing process on schedule. Camera sensors and radio frequency identification labels for receiving goods allow for automated monitoring of supplies. Automated lifts, conveyor belts, stackers, and electronic pallet trucks simplify working environments, while a robot arm, once implemented, will automate sorting and disinfection.Such process optimization helps employees stay engaged in relevant work while minimizing the potential for human error. And greater insights into how their molecules are progressing through each step of development and manufacturing empower clients to make well-informed decisions throughout the partnership.We understand our clients’ critical need for consistency and minimal batch variation, supported by simplified, standardized, and flexible processes. Reliable execution of best practices in operations through the use of digitalized and automated systems benefits both clients and operators. The reduced potential for human error, in turn, lessens overall complexity throughout the facilities. Consistent quality is ensured, resulting in safe, quality medicines being delivered to patients worldwide. Bio Campus II and beyondBio Campus II, where these advanced plant and storage systems take shape, will also house an Open Innovation Center. Samsung Biologics aligns with the needs of its current and future clients by fostering an ecosystem for biotech incubation and encouraging technological innovation. The Open Innovation Center will initially support biotechs by providing them with development services in the short term and manufacturing se

Enhancing productivity and antibody-dependent cellular cytotoxicity (ADCC) activity is key to developing high-performing antibody therapeutics. With the right approach and technology, there’s no need to compromise. Our S-CHOice® and S-AfuCHO™ platforms are designed to optimize cell line performance, ensuring robust productivity while maintaining strong effector function.Read More

development timelines and optimize manufacturing quality.Read More

development of bsAbs can pose challenges in the purification process during manufacturing, such as mispairing during assembly. Through improved molecular design to promote correct chain pairing, optimized bioprocessing techniques, and advanced analytical methods to ensure high product purity and efficacy, Samsung Biologics’ S-KiH platform ensures bsAb manufacturability. S-KiH streamlines the bsAb manufacturing process, reducing costs and enhacing overall clinical viability. In combination with S-DUAL™, S-KiH can accelerate the development of next-generation bsAb therapeutics, making them more accessible and scalable for diverse medical applications. Learn more in our latest whitepaper.

development and manufacturing of next-generation therapeutics. Read More

development and manufacturing organization (CDMO), today announced financial results for the first quarter of fiscal year 2025.“We sustained solid momentum in the first quarter, supported by the efficient operations across all our plants and continued partnerships with our clients,” said John Rim, CEO and President of Samsung Biologics. “The launch of Plant 5 and our dedicated antibody-drug conjugate (ADC) facility marks another milestone in expanding our capacity to cater to diverse client demands. We remain committed to delivering long-term value for clients and shareholders through strategic investments in technology while continuously offering competitive advantages with our development and manufacturing capabilities.” FIRST QUARTER 2025 RESULTSSamsung Biologics reported consolidated revenue of KRW 1.3 trillion in the first quarter of 2025, mainly driven by the stable ramp-up of Plant 4 while maintaining the full utilization of Plants 1 through 3, alongside favorable impact of foreign exchange rates. The company maintains its full-year earnings guidance of 20–25% revenue growth.On a standalone basis, Samsung Biologics posted revenue of KRW 999.5 billion and an operating profit of KRW 430.1 billion. [Consolidated Earnings, KRW billion] [Consolidated Earnings, KRW billion]Q1’25Q1’24YoY ChangeRevenue1,298.3946.9351.4Operating Profit486.7221.3265.4EBITDA650.1364.7285.4BUSINESS UPDATESSamsung Biologics continues to secure new CDMO contracts, signing a deal worth USD 1.4 billion with a Europe-based pharmaceutical company in January, followed by additional contracts in April. The expanded partnerships reflect the company’s capability to delivering consistent quality and clients’ trust in Samsung Biologics’ services.Plant 5 commenced operations as committed in April this year. The new plant incorporates advanced technologies and digitalized features, including an integrated manufacturing execution system, to further enhance operational efficiency and quality excellence. Plans to build a sixth plant in response to growing biomanufacturing demand are currently awaiting board approval. Samsung Biologics’ ADC facility also commenced operations earlier this year, further building on the company’s capability to support diverse modalities.For the CDO business, growth was supported by upgrading technology platforms as well as enhancing service quality. Samsung Biologics signed an agreement to carry out multiple ADC projects for LigaChem Biosciences. The company also continues to support the growth of emerging biotechs through the Samsung Life Science Fund, with its latest investment being made in C2N Diagnostics, a US-based biotech firm developing blood-based diagnostics for early detection of Alzheimer’s disease.In line with Samsung Biologics’ geographic expansion strategy to better support a broader client base and strengthen its regional presence, the company opened a sales office in Japan this year.Samsung Biologics remains committed to sustainable and responsible growth. The company was given a ‘Low Risk’ rating and selected as an ‘Industry Top Rated’ company by Sustainalytics, and received leadership status for water security from the Carbon Disclosure Project. As a member of the Sustainable Markets Initiative’s Health Systems Task Force, the company also continues to contribute to the decarbonization of healthcare supply chains in partnership with stakeholders across the public and private sectors.

development and manufacturing present significant technical and regulatory complexities. Our latest whitepaper outlines key considerations for addressing these challenges — from molecular design and process development to scalable manufacturing strategies. Learn how Samsung Biologics applies seven strategic pillars to support the efficient development of multispecific antibodies.

development challenges and how Samsung Biologics has the expertise to support Japanese biopharmaceutical companies. Read the full interview (Japanese) here

A well-designed downstream process (DSP) is critical to achieving high-quality purification within a short timeframe and at reduced cost. This whitepaper discusses how: in silico analysis accelerates resin selection, alternative resins offer cost-effective solutions without compromising quality, and early scaling strategies help ensure a smooth transition to commercial production. Explore how an optimized DSP approach can accelerate your path to commercialization.

development risks early. With the latest update to DEVELOPICK™ 3.0, Samsung Biologics offers an in-house in silico assessment program, enabling precise molecular evaluation while securing sensitive data. Watch the webinar to explore how the advancement enhances risk identification, molecular evaluation, and data security in the development process.

development of saRNA drug substance. In the face of falling protective immunity within three to six months after flu vaccine administration, low-dose saRNA vaccines can offer the global health landscape the needed agility alongside prolonged clinical effectiveness. Lipid nanoparticle ecosystem In addition to saRNA technologies, effective and safe lipid nanoparticles (LNPs) that deliver mRNAs into targeted regions of the patient body through encapsulation and receptor-mediated endocytosis are key. Samsung Biologics is actively collaborating with LNP platform companies to support global biotechs.A CDMO that makes for an integral partner in mRNA manufacturing and development has extensive experience with formulation using diverse excipients for LNPs. According to Hyukjin Lee, Professor at Seoul National University who gave a lecture in January as part of the Samsung Biologics Biotechnology Advisory Board, the remaining tasks in LNP development are twofold: to mitigate any adverse effects in the body, and to readily eliminate LNPs once their job is done, safely making way for possible repeated administration.Samsung Biologics is setting up efficient delivery platforms by investing in and collaborating with LNP platform companies through the Samsung Life Science Fund. Haenaem Mac Kwon, Director of the mRNA technology Group, says Samsung Biologics takes this win-win approach to optimize the mRNA drug substance and LNP drug product manufacturing for clients.Additionally, research is well underway for LNP formulations that can be stored at room temperature or refrigerated. This new approach increases the stability of LNPs for mRNA drugs, in turn providing more options of the lipid pool for clients.Looking toward a universal vaccine Lee imagines a cancer vaccine that is personalized to each patient, tackling rare diseases using CRISPR technology alongside mRNA therapies. By first succeeding in developing a universal saRNA vaccine for handling diverse antigenic variants, the technology could be adapted to educate the immune system for neoantigens in the patient body. “Each mutation is different in each patient,” he says.From plasmid DNA linearization and purification to encapsulation, aseptic fill-finish, and cold chain storage, Samsung Biologics offers one-stop manufacturing as well as bioanalytical services alongside research and development.“We’re keen to partner with mRNA biotechs as well as LNP platform companies to bring vaccines and therapeutics to clients worldwide,” says Kwon. “Let’s work together to tackle more disease mechanisms with new modalities.”Related contentsSamsung BIO Insight The Power of One I Samsung Biologics’ mRNA CapabilitiesWhitepapers Optimized residual dsRNA detection for mRNA therapeuticsWhitepapers Ultra-cold chain and supply chain management strategies for mRNA

development strategy and how it can help promptly overcome challenges, in their article in International Biopharmaceutical Industry.Read More (pages 40-42)

development workflows, Samsung Biologics not only reduces time and costs but also enhances the quality of the final product.In the latest discussion with Contract Pharma, Kyoungmin Lee, Senior Scientist of Structure Analytics, shares the role SVA plays in biologics drug development, the capabilities and tools needed to accelerate SVA, address risks, and more. Read on to learn about how we can be your strategic partner in drug development.Read More

development with tailored CMC strategies, scalable production, and expertise in regulatory compliance—all while ensuring safety and efficacy.Discover how Samsung Biologics empowers drug developers with advanced technologies and a quality mindset to meet evolving industry demands.Read More

development, offering a one-stop solution to facilitate your path to commercial. Check out this speaking session where Eunseo Lee, Lead Manager in mRNA Manufacturing, presents on our mRNA platforms for next generation therapeutics, from concept to clinical validation and commercialization.

Development Director Song Young Kim shares his insights on overcoming ADC manufacturing and supply chain challenges. "Since ADCs consist of an antibody, a cytotoxic payload, and a chemical linker, companies tend to rely on different vendors for each component, complicating the supply chain. Biotech and pharmaceutical companies are overcoming these challenges by partnering with CDMOs that have specialized facilities for ADC manufacturing and the analytical capabilities necessary to support every step of the journey." Read more in the latest Pharma Manufacturing article.

development and manufacturing service providers based on global client feedback in various areas such as facilities, innovation, technical expertise, and manufacturing capabilities. “We are grateful to receive the recognition and appreciate our clients and partners for the trust and confidence they have in our services and capabilities,” said John Rim, CEO and President of Samsung Biologics. “The award underscores our commitment to deliver high-quality biomedicines and maximize client satisfaction by prioritizing quality and operational excellence at all times.”“We are thrilled to introduce our 2025 CDMO Leadership Awards winners to the Outsourcing community, and honored to offer such an important tool for drug sponsors in selecting their best-fit partner to help bring life-saving therapies to market,” said Louis Garguilo, Chief Editor of Outsourced Pharma. “The new categories and enhanced scoring methodology that went into this year’s appraisal bring an improved experience for drug sponsors using the resource as well as an ever-so-coveted distinction for the CDMOs.”Samsung Biologics continues to build on its capabilities and expand its capacity to readily address the evolving needs of clients." The company's fifth plant will become operational next month, bringing the total capacity to 784,000 liters. Samsung Biologics has also diversified its portfolio by providing end-to-end ADC services at a dedicated facility in Songdo.

development of talent and bioprocess infrastructure, Samsung Biologics is proactively supporting research activities. The company established a Co-Prosperity Cooperation Center to foster concrete communication and win-win opportunities."Supporting academic research is how Samsung Biologics can prosper with universities,” said Dongjoong Kim, Head of the Co-Prosperity Cooperation Center, "We will do our best to strengthen industry-academic cooperation by continuously seeking ways to support research activities."

development and manufacturing of safe, high-quality biologics. People excellence through continuous learningTo ensure smooth work processes and a one-team mindset throughout the organization, Samsung Biologics offers various training programs for employees. Each session builds expertise in their respective roles and enhances leadership or followership skills to create synergy within teams and thread quality into every step of the biologics journey. “The company provides a strong foundation for learning, allowing trainees to grow into experts. From basic training courses to intensive sessions for each job function, the curriculum is systematically planned to provide employees with the expertise they need. We can also be trained for diverse roles to better understand the entire biomanufacturing process. VR training courses also give us hands-on experience before being put on the job to proactively minimize any mistakes.” Jiwon Chun, MFG Investigation QA “In addition to the training, each department also encourages continuous learning and growth. The MSAT team, for example, holds cross-training whereby subject matter experts give internal seminars about their functions and actual case studies. This enables us to get a better understanding of the entire development or manufacturing procedure and better solve any issues that may arise.” Seohee Lee, P4 DSP The company also invites external experts to give in-depth lectures on various relevant topics, providing employees with food for thought and widening their perspectives. Besides training opportunities, the exponential growth of the company has also fostered learning opportunities. “At Samsung Biologics, we manage a wide range of large-scale manufacturing projects. As the process differs for each client or product, we can gain diverse experiences, even for the cell culture process alone. As we continue to build new facilities, we bring in the latest equipment and technologies – enabling us to grow our expertise. Recently, we’ve started to implement digital twin technologies and artificial intelligence into our processes, adapting to changing trends and setting new norms for the industry.Daewee Kim, Cell Culture 3-OP2 “I’ve been able to learn a lot especially by planning and designing the entire manufacturing process. As we continue to expand our facilities and new technologies are introduced, this translates into growth for us as individuals. Being able to take part in the manufacturing of various products from diverse clients is a true learning opportunity that I’m grateful for.”Seohee Lee, P4 DSP People excellence through work-life balanceIn addition to fostering expertise, Samsung Biologics is also committed to providing work-life balance for our employees to ensure their physical and mental well-being. The five-story Bio Plaza is occupied with everything employees need in their daily life – from a cafeteria, bank, gift shop, convenience store, hair salon, and gym to a medical center and even a skincare clinic.To ensure dietary health, the company provides a selection of nutritious meals, from vegetarian menus to take-out salads, from dusk to dawn and free of charge. Employees can also enjoy a cup of coffee or piece of cake at the café or bakery. "As the company provides a wide selection of healthy meals throughout the day, I don't need to worry about my nutritional diet or decide where to go for lunch each day. As everything can be taken care of within the company, I can better utilize my time to relax or focus on my work." Yujeong Kim, Public Affairs Samsung Biologics also offers a range of options for employees to maintain a healthy lifestyle. The company gym, encompassing an area of about 2,000 m2, boasts a lineup of premium fitness equipment as well as personal training programs and pilates classes. Samsung Biologics also has the Medical Zone, comprised of a clinic, a dental clin

development capabilities can support clients’ programs.

development, and technical training programs can help women advance in this field.” “Encouraging more women to pursue careers in biopharmaceutical development, manufacturing, and quality can bring fresh perspectives that enhance operational excellence,” says Diane. “Diverse leadership teams have shown to drive better decision-making, improve problem-solving, and contribute to a richer workplace culture.”Samsung Biologics is a strong advocate of professional development initiatives designed to foster a more inclusive workforce. By investing in mentorship programs, leadership training, and courses that promote career growth, the company is working to build a diverse talent pool that strengthens both the organization and broader industry. Building a quality cultureEnsuring product quality in biologics development and manufacturing requires a sense of collaboration, continuous learning, and trust within teams. Diane highlights the importance of creating an environment where employees feel empowered to voice concerns and contribute to solutions.“Trust is essential. When people feel supported, they’re more likely to speak up and take initiative,” she says. “A strong quality culture isn’t just about following procedures – it’s about fostering open discussions, refining processes, and ensuring that everyone has the opportunity to contribute to better outcomes.”At Samsung Biologics, the emphasis on quality extends beyond management and compliance—it’s about continually improving processes to enhance efficiency while pursuing the highest standards. Diane underscores the importance of re-evaluating long-standing procedures to optimize workflows and simplify complex processes.“We’ve been operating for over a decade, and each inspection has led to additions in our procedures. While these are important, we also need to step back and ask, ‘Do all these steps make sense? Is there a more effective way of doing this?’” she notes. Another core focus for Diane is strengthening leadership at every level, ensuring employees are motivated and feel supported in their roles. “From associate directors to center heads, we need to train and equip them with the right tools and expertise to effectively guide their teams,” she says. “As important as maintaining high standards is the fostering of a culture where employees feel comfortable enough to raise concerns and seek ways to continuously improve how we work.”Fostering an inclusive workforceBuilding an innovative and passionate workforce goes beyond technical training—it requires leadership development and a culture that values inclusivity. Diane stresses the importance of mentorship and confidence-building programs, particularly for women aspiring to leadership roles.“One of the biggest hurdles I see is imposter syndrome,” she says. “Many women hesitate to step into leadership roles because they feel they need to meet every requirement perfectly. But careers aren’t always linear—taking risks, learning from different roles, and speaking up are all part of the growth process.”In that sense, Samsung Biologics continues to invest in training and mentorship to ensure employees feel empowered to take on leadership positions. By fostering a workplace that values trust and inclusivity, the company hopes to help shape the future of biologics development and manufacturing. Driving positive change Amid continuous expansion of the biopharmaceutical industry, Samsung Biologics is committed to building a workplace where talent—regardless of gender and age—can thrive and contribute to the industry’s future.“We can’t change everything overnight, but we can definitely create environments where people are heard, valued, and empowered,” Diane says. “If we focus on that, we can build a stronger, mo

How can high-concentration biologics be formulated to enhance stability, manufacturability, and patient convenience? With increasing demand for high-concentration antibodies, developers must address challenges such as viscosity, phase separation, and protein aggregation—all of which can impact formulation performance and production. Our latest whitepaper explores these complexities and how the S-HiCon™ platform applies advanced analytical techniques and risk mitigation strategies to optimize high-concentration formulations.

development and manufacturing.” For a closer look at how AI is revolutionizing the pharmaceutical landscape and addressing challenges that remain, explore this Pharma's Almanac roundtable discussion.Read More

Development Director, antibody-drug conjugates (ADCs) had already been in the market for more than two decades, yet garnering attention once more for their targeted therapeutic effects and promising clinical applications. Now with over a dozen FDA-approved ADCs in the market and many more candidates, the biopharmaceutical industry is looking to scale up development and production of these high-quality biomedicines. Partnership with trusted contract development and manufacturing organizations (CDMOs) is ever more key.Kim and his team are in charge of advancing ADC services at Samsung Biologics and setting up process development in the CDMO’s new ADC facility, to which they relocated in early February. The cost of process development for linker-payload conjugation to the antibody moiety as well as specialized facilities for handling toxins can present a hurdle when manufacturing ADCs. The modality also requires analytical and formulation methods to accommodate their high hydrophobicity and low stability relative to monoclonal antibodies. ADCs can be unstable in the liquid state, for example. Triin Jurgenson, senior scientist in ADC process development in Kim’s team, puts it like this: “In order to produce more homogeneous ADCs, the conjugation process tends to become more complex.”End-to-endAt Samsung Biologics, expertise in EPCV (engineering, procurement, construction, and validation) and prioritization of safety protocols for handling toxins, such as isolators and fume hoods, make for a smooth transition into the new venture.Located across Bio Campuses I and II at in a separate location, the four-story standalone facility at Samsung Biologics allows for ADC conjugation right near where the antibodies are made. “It can be that at a given CDMO, the antibodies are manufactured separately, conjugation is carried out separately, and the drug product is made separately,” says Ryuryun Kim, lead scientist in ADC process development. What ensure the quality, safety, and efficacy of ADCs, according to Thomas Rohrer, Senior Director of Technical Support for Bioconjugates, are meticulous analytical capability and a flexible manufacturing environment that can adapt to the changing conjugation chemistries required in the next generation of ADCs. “Samsung Biologics has the ability to engineer the targeting agent to improve the specificity, ADCC response, and homogeneity of the ADC,” he says. Based in Washington D.C. and working with the Samsung Biologics America team in New Jersey and the campus in Songdo, Rohrer envisions a “one-stop shop.” He believes such a vision is possible with Samsung Biologics’ new ADC facility, with process development and manufacturing experience paired with advanced analytical services to support ambitious timelines for drug product delivery. World-class analytical technology for characterization and stability complements ADC drug substance and product manufacturing capability.Driven by this shared goal, the Samsung Biologics ADC team has been setting up experiments around the clock to kick-start prospective clients’ projects, run validations, and study standard operating procedures to determine feasibility. The global CDMO has the ability to perform stability analyses of the drug substance and drug product to ensure that ADCs maintain their integrity and efficacy from early clinical phase to commercial manufacturing. Comprehensive analytical techniques allow the team to identify the structural robustness and monitor intermediate samples from process development and manufacturing.One TeamSenior scientist in ADC analytical development Seokho Hong commends his team members for fostering a healthy, collaborative work culture. “The patient-centric fabric of Samsung Biologics enables the collective persistence necessary for overcoming the challenges of not only setting up a new laboratory environment, but also meeting the needs of clients wit

development of the life sciences R&D industry.”

development of novel therapies and bring them to patients faster.” For insights on the importance of strong partnerships to advance new treatment options and the growing potential of drug conjugates, check out this Medicine Maker roundtable.Read More

development organization (CDMO), today announced that it has received ‘Leadership’ status and an A- rating for water security from the Carbon Disclosures Project (CDP), underscoring the company’s efficient water resources management. The company participated in the category for the first time. CDP is a non-profit organization that evaluates the corporate environmental transparency and performance of over 24,800 companies listed worldwide. The rating recognizes Samsung Biologics’ efforts to implement ESG strategies to improve resilience as well as set goals to manage water pollution and consumption. “As a sustainable CDMO, we are continuously striving to incorporate ESG principles into our operations to help achieve our net zero transition and provide more sustainable services,” said John Rim, CEO and President of Samsung Biologics. “We are also working alongside leading global pharma companies to encourage our suppliers to build sustainable supply chains and contribute to driving change across the healthcare industry. At Samsung Biologics, we have signed renewable Power Purchase Agreements (PPAs) and plan to improve water resource management, as well as preemptively assess risks across our operations to minimize environmental impact.” As the champion of the Supply Chains Working Group within the Sustainable Markets Initiative (SMI) Health Systems Task Force, Samsung Biologics collaborates with global pharma companies as well as the public and private sectors to drive action towards a heathier, sustainable future. The company is accelerating the transition to renewable energy through PPAs and improving Product Carbon Footprint measurements as part of its commitment to achieve net zero by 2050. The global CDMO has also been making efforts to reduce emissions by utilizing low-carbon technologies, such as high-efficiency boilers and energy monitoring systems, and installing solar panels across its facilities. Samsung Biologics will also continue to improve water-use efficiency.

development platforms, and reliable digital systems to add flexibility and trust to partnerships.”The biopharmaceutical industry is responding well to last year’s prediction from the US FDA that more clinical activities in complex molecules would be underway. Hundreds of them, such as bsAbs and antibody-drug conjugates (ADCs), are in trials, with a couple dozen of them approved to date. While the race toward developing complex molecule pipelines is on and expected to become more competitive, Samsung Biologics is and will be prepared to provide service readiness. The leading CDMO in recent years has been continuously diversifying its development platform portfolio, such as S-DUAL™, which leverages asymmetric lgG-like structures to generate perfect pairings and maintain a bsAb purity level of over 95%. In tandem with technical advancements, Samsung Biologics is on the path to launching two end-to-end plants in 2025. A standalone ADC facility, in which both development and manufacturing of ADCs will take place at scale, will come online in February. And in April, the 180,000-liter Plant 5 will be cGMP ready as the first sequence of Bio Campus II construction, which upon completion by 2032 will add fresh capacity of 720,000 liters to the existing 604,000 liters in Bio Campus I. Samsung Biologics’ delivery of its expansion plans not only enhances trust with its clients but also addresses their concerns over future project pathways. “The way Samsung [Biologics] is building new plants and adding capacity in the future gives us the confidence that a year or two from now, there will be adequate capacity, if our project is successful, for us to continue to work together,” a senior executive at a U.S. biotechnology company told Samsung Biologics. In an ongoing effort to strengthen trust and learn to adopt the client’s perspective, Samsung Biologics has been incrementally building up its digital infrastructure. Starting with digitalization across manufacturing operations, a client portal has enabled clients to glean a specific record from project files. Building and improving readiness to meet evolving industry demands is the work of Samsung Biologics employees—who help the organization plan well, make good decisions, and execute well. The culture enabled by the Four Pillars of Excellence drives the Samsung Biologics team to deliver on promises made to clients. “At the end of the day, we have great facilities, great technology, great processes, and great execution; but it is the people [at Samsung Biologics] who make that happen,” said Rim as he was wrapping up his presentation at the J.P. Morgan Healthcare conference. Related ContentsPress Release Samsung Biologics presents business updates at 2025 J.P. Morgan Healthcare ConferenceSamsung BIO Insight Quality mindset in operations for client excellence

development and manufacturing organization (CDMO), today announced financial results for the fourth quarter and fiscal year 2024."2024 has been a year of steady progress for Samsung Biologics as we expanded collaboration with both pharma and biotech companies, supported by our focus on operational and quality excellence," said John Rim, CEO and President of Samsung Biologics. "We have been able to continue delivering on our commitments by investing in capacity, modality, and geographic expansion. We expect another year of growth through the opening of Plant 5, launch of ADC services, and continued investment in innovative technologies and sustainability. These efforts will enable us to better address the evolving needs of our clients at the right time." FOURTH QUARTER & FISCAL YEAR 2024 RESULTSIn the fourth quarter of 2024, Samsung Biologics achieved a consolidated revenue of KRW 1.26 trillion while operating profit stood at KRW 325.7 billion. This growth was driven by the increased contribution from Plant 4 and full utilization of Plants 1 through 3.Full-year 2024 consolidated revenue was at KRW 4.55 trillion, a 23% increase from KRW 3.69 trillion in 2023. Operating profit increased by 19%, totaling to KRW 1.32 trillion.[Consolidated Earnings, KRW billion] Consolidated Earnings, KRW billion Q4’24Q4’23YoY ChangeFY24FY23YoY ChangeRevenue1,256.41,073.5+182.9(+17.0%)4,547.33,694.6852.7(+23.1%)Operating Profit325.7350.0-24.3(-6.9%)1,320.11,113.7206.4(+18.5%)EBITDA476.5491.9-154(-3.1%)1,919.21,603.5315.7(+19.7%)On a standalone basis, Samsung Biologics recorded a revenue of KRW 3.50 trillion and an operating profit of KRW 1.32 trillion in 2024. In the fourth quarter of 2024 alone, the company posted a revenue of KRW 950.4 billion and an operating profit of KRW 314.7 billion. Samsung Biologics has served over 110 clients, including 17 of the worlds’ top pharma companies, reinforcing its position as a trusted partner in the biopharmaceutical industry. These partnerships supported the company in surpassing a total contract value of USD 4.3 billion in 2024, contributing to a cumulative contract value of USD 16.3 billion. The company achieved 340 regulatory approvals as of December 2024, underscoring its commitment to quality and operational excellence. FISCAL YEAR 2025 OUTLOOK Full Plant 4 operations are expected to drive further revenue growth, while Plant 5 at Bio Campus II, scheduled to begin operations in April 2025, will expand the company’s total production capacity to 784,000 liters. The company is also considering the construction of a sixth plant to proactively respond to the growing demand for biologics, which would increase total production capacity to 964,000 liters upon board approval.The dedicated ADC facility will address the growing need for ADC-based therapeutics by supporting the delivery of next-generation biomedicines. Additionally, the company’s innovative platforms S-HiCon™, S-Tensify™, S-AfuCHO™, and S-OptiCharge™ will offer clients enhanced flexibility, productivity, and quality for successful drug development.Samsung Biologics plans to further optimize operational efficiency and project timelines by investing in AI and digital transformation to automate systems and facilities. The company is also expanding its drug product (DP) capabilities, with a fully automated pre-filled syringe DP line projected to be CGMP-ready by 2027.Samsung Biologics continues to actively advance sustainability efforts. As a member of the Sustainable Markets Initiative’s Health Systems Task Force, the company is committed to developing practical guidelines for decarbonizing healthcare supply chains in collaboration with global leaders in public and private health sectors. By strengthening partnerships with suppliers and incorporating ESG principles into the value chain, Samsung Biologics aims to drive meaningful progress in its sustainability initiatives.For

development and manufacturing. Three of our industry veterans - Daniel Buckley of drug development, Soyeon Ahn of drug substance manufacturing, and Sungjin Park of drug product manufacturing - provide their real-life thought leadership on how working with a quality-minded CDMO leads to agile problem-solving of biopharmaceutical challenges. Read this European Biopharmaceutical Review article to learn how CDMOs can cultivate a culture of quality. Read more (page 13)

development (CLD) strategy? At Samsung Biologics, we’re continuously innovating to enhance existing platforms and meet diverse biomanufacturing needs. Advance your CLD with transposase technology and FUT8 knockout engineering integrated into our S-CHOice® platform. With resulting superior ADCC activity, antibodies generated from this S-AfuCHO™ line are more potent and show lower levels of fucosylation. Paired with higher purity and product yield enabled by transposase systems, this dual technology helps speed up timelines while maintaining high quality. Check out our latest poster to learn more!

development of bioprocess digital twins is the application of computational fluid dynamics (CFD) technology. Samsung Biologics is at the forefront of this technological evolution, leveraging CFD and digital twin technologies to achieve unparalleled quality management. Harnessing digital twin technology, Samsung Biologics optimizes process development, streamlines technology transfers, and evaluates process changes and scale-up manufacturing operation. This whitepaper provides insights on the CFD advantage at Samsung Biologics. Find out how we are paving the way for more efficient, accurate, and scalable bioprocess solutions.

development and manufacturing capabilities to better address clients’ needs Incheon, S. Korea, Jan 15, 2025 – Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), today announced its latest business achievements and 2025 outlook at the 43rd J.P. Morgan Healthcare Conference, which was held in San Francisco between January 13-16.During the main track presentation, Samsung Biologics’ CEO and President John Rim said, “Despite industry challenges, Samsung Biologics is well positioned to kick-start a new phase of growth in 2025 with the opening of Bio Campus II and launch of antibody-drug conjugate (ADC) services.” He added, “We’ll continue to invest in new modalities and technologies to better address client needs, maximizing satisfaction and ensuring the delivery of highest-quality products.”Key business updates include:ADC services: To address the increasing demand for ADC-based therapeutics, Samsung Biologics has commenced ADC services at its new dedicated facility. Building on the company’s expertise in large-scale antibody manufacturing and process engineering, Samsung Biologics’ service scope spans late stage discovery, development, and conjugation. Samsung Biologics recently expanded its collaboration with LigaChem Biosciences to support a series of their ADC programs at Samsung Biologics’ new dedicated ADC facility.Opening of Japan office: To better support Samsung Biologics’ expanding global client base, the company announced plans to open a regional office in Tokyo this year. The local presence will boost Samsung Biologics ability to support and grow its increasing partnerships in Japan.Expanded Drug Product (DP) services: As part of continued efforts to expand service offerings, Samsung Biologics is investing in pre-filled syringe (PFS) capabilities. The company’s fully automated PFS DP line will be CGMP ready by 2027.Enhanced development capabilities: Samsung Biologics plans to better support global pharma and emerging biotech companies by investing in core development capabilities. The company is offering services incorporating new tech platforms, including S-HiConTM, S-TensifyTM, S-AfuCHOTM, and S-OptiChargeTM, that ensure higher productivity and quality of a molecule for successful and accelerated drug development.Capacity expansion: Samsung Biologics will mark a new phase of growth with the opening of Bio Campus II this year. Plant 5, the first facility of the new site, will be operational in April this year and bring up the total capacity to 784,000 liters. The company is also considering the construction of a sixth plant to proactively respond to the increasing demand for biologics which will increase its total production capacity to 964,000 liters, upon board approval.Digital transformation: As part of efforts to maximize operational efficiency and client satisfaction, Samsung Biologics will continue to invest in further building its integrated digital systems spanning quality, manufacturing, and operations. Incorporating artificial intelligence and digital twin technology, the company plans to provide clients with data-enabled solutions and insight to optimize project timelines without compromising quality.

development strategies, highlighting its comprehensive support for clients at every stage, from early development to commercial production. It also presents case studies on the performance outcomes of Cysteine and Lysine conjugation methods.

development and manufacturing organization (CDMO), today announced to extend collaboration with LigaChem Biosciences (KOSDAQ: 141080) to provide antibody-drug conjugate (ADC) services. Samsung Biologics will support a series of LigaChem Biosciences’ ADC programs at Samsung Biologics’ new dedicated ADC facility. The two companies have already been working on ADC programs for the treatment of solid tumors. LigaChem Biosciences is a biotech pioneering research and development of ADC candidates. “The latest collaboration will further strengthen Samsung Biologics’ capabilities across all stages of ADC development and manufacturing as part of our commitment to deliver safe and high-quality therapeutics to patients,” said John Rim, CEO and President of Samsung Biologics. “We look forward to supporting our clients’ innovative ADC pipelines, ensuring the highest quality and timelines are met.” “This collaboration with Samsung Biologics will be an important step toward strengthening the supply chain of high-quality ADC drugs and enhancing the competitiveness of both companies in the global ADC market,” said Yong-Zu Kim, LCB’s President and CEO. “By leveraging Samsung Biologics’ extensive experience as a CDMO, we will accelerate the development of our pipeline and quickly provide innovative ADC treatments to patients”. Samsung Biologics’ ADC facility is a segregated suite, equipped with a 500-liter reactor, supporting the development and manufacture of ADC therapies. Building on the company’s track record of expertise in large-scale antibody manufacturing and process engineering, Samsung Biologics’ ADC service scope spans late discovery to development and conjugation. Samsung Biologics has also been making active investments through the Samsung Life Science Fund in biotech companies pioneering ADC linker technologies, toolbox, and protein engineering.For more information, visit: https://samsungbiologics.com/services/adc

DevelopmentOn top of capacity expansion to meet growing market demand, Samsung Biologics also makes bold investments in advanced technologies to enhance its capabilities to support complex projects, including multispecific antibodies. In 2024, the company launched a number of tech development platforms to enhance therapeutic efficacy, accelerate timelines, and ensure highest quality.▶ Samsung Biologics CDO: Geared towards fusion protein medicines▶ Samsung Biologics launches development platforms for enhanced therapeutic efficacy▶ Samsung Biologics launches high-concentration formulation platform to accelerate high-dose drug development▶ Agile. Flexible. Focused on You. Continuous Pursuit of ExcellenceSamsung Biologics continues to build on its core strengths and deliver on its commitment to superior client satisfaction though operational excellence, innovation, and highest quality. The company makes it a priority to cultivate a quality mindset and culture among all employees, while continuing to find improvement points to optimize processes and maximize efficiency.▶ What defines a quality culture at Samsung Biologics?▶ Optimized operations for reliable biomanufacturing▶ Virtual technologies to enhance quality mindset and transform learning culture▶ The “Samsung Biologics Way” builds trust and ensures client satisfaction In 2025, Samsung Biologics will open a new phase of growth at Bio Campus II with the completion of Plant 5 as well as the launch of comprehensive ADC services at our dedicated facility. We will look forward to another year of boundless opportunities and collaboration with our clients to support their biologics’ journey, and ultimately help patients. Want to stay on top of news from Samsung Biologics?Sign up for our monthly newsletter or visit our Newsroom!

development and manufacturing organization (CDMO), today announced its continued recognition by the Dow Jones Sustainability World Index (DJSI), a globally recognized benchmark for evaluating the sustainability performance of over 2,500 publicly traded companies.Samsung Biologics was recognized for its dedication to embed sustainable business practices across its operations, particularly robust environmental efforts, including progress toward achieving net-zero emissions and an enhanced focus on carbon reduction across the value chain. The company has been listed for four consecutive years.“This achievement demonstrates our commitment to driving sustainability across our operations and the broader biopharma value chain,” said John Rim, President and CEO of Samsung Biologics. “We remain focused on delivering meaningful progress toward a net-zero future while supporting our clients and partners with their ESG goals and contribute to a healthier world.”Samsung Biologics continues to advance ESG initiatives, including its leadership role within the Sustainable Markets Initiative (SMI). As a champion of the Supply Chains Working Group in the SMI Health Systems Task Force, the company actively engages global suppliers to decarbonize and build more resilient value chains. The global CDMO is accelerating transition to renewable energy through its Power Purchase Agreement, Renewable Energy Certificate, also having completed Product Carbon Footprint measurements to support our clients in achieving net-zero. This year, Samsung Biologics joined the Pharmaceutical Supply Chain Initiative and also received an EcoVadis platinum sustainability rating.

development and documentation of standard operating procedures (SOPs) and the management of vast records necessary for good manufacturing practice (GMP) compliance. For contract development and manufacturing organizations (CDMOs), this process is further intensified by specific client due diligence requirements and frequent audits. Maintaining comprehensive documentation and being inspection-ready are non-negotiable. Traditional methods, such as manually sifting through extensive internal databases to locate and verify records — whether for SOPs, deviations, corrective and preventive actions (CAPAs), or change control (CC) — are time-intensive and prone to delays. These inefficiencies underscore the urgent need for advanced solutions that streamline operations and ensure seamless compliance. Artificial intelligence (AI)-driven platforms present a transformative opportunity to optimize operations and stay ahead of regulatory expectations. By enhancing inspection readiness and operational workflows, AI in drug manufacturing can bolster regulatory compliance, mitigate risks, and deliver significant benefits beyond compliance. These include increased productivity, reduced operational costs, and improved service quality. In an industry where precision is paramount, AI offers a competitive edge by optimizing processes and addressing long-standing operational challenge.

development facilities all in one site,” said Hyunjin Choi, Director of Client Quality. She remarks that harmonizing is what her team does – while plants and facilities can be separated and each plant has different characteristics, the role quality professionals play in the company permeates the broader culture.Quality teams can also be a proactive partner within the company, informing other teams of how processes are run in faraway corners of the organization. “Each team may not always be aware of what each another is doing, whereas quality teams can see what each plant is doing, for example,” said Alex Jung, Senior Director of Quality System & Compliance. “This is like how we can see that status of each project, thanks to the robust database we have built from a track record of serving biopharma companies around the world.”“A quality culture trickles down, but it is also baked into each level,” said Samsung Biologics’ data compliance expert. To encourage a culture of reporting deviations or other inevitable instances of human error, employees need to be assured that there will be no penalties. An anonymous reporting system, for example, helps bring such issues to immediate attention.Constructive course correctionSince 2012 when Jung first joined Samsung Biologics, appreciation for quality teams from other departments has grown – and so have expectations. “Quality is everyone’s shared responsibility. Whereas agility is already part of our DNA, when quality is lacking, it is detrimental not only to the company but more so to those we partner with and serve,” Jung said. “Quality is a non-negotiable.”Hand-in-hand with speed, another strength of Samsung Biologics as seen by the data compliance expert is execution. “This means we can correct course fast,” they said. Encouraging ownershipTo Eunah Yoh, Director of Client Quality, shedding light on the client’s perspective for her team members from a bird’s eye view is how she offers clarity in times of potential uncertainty. “By adding two more lines of explanation to the originally single line, I seek to explain the background of a given task in detail,” Yoh said. “We can move forward together once the purpose and background of a task are fully explained and aligned on.” Giving challenging but fruitful work is how Jung motivates his team. “Creativity is an important trait prospective members should have,” he said. “Rather than passively following given procedures, discerning which is the more efficient and effective path to take is a skill.”Sustaining a quality culture that encourages employees to take ownership of their work means employees need to grow together. Such passionate ownership seen in junior specialists is one reason why the data compliance expert comes into work. “Ownership, responsibility, passion – leaders need to show this first,” they said. “Then, positive influence spreads outwards.” Training and education along with technological tools to reduce human error are how Samsung Biologics proactively nurtures a quality culture. Using digital media and the internal company portal, the webzine format was used to reach employees and share case studies. An opportunity to study trends and stay vigilant about data compliance, the initiative is evolving to be even more personalized so that it is impactful to each individual. “If the individual has no personal motivation, external accountability alone cannot create it,” the data compliance expert said.Come full circleTo Choi, thinking about how the medicines can potentially reach her own family members is what drives everyday decision-making. “Separate from being the director of a team, I am just one individual,” she said. “Beyond being able to have experiences in Samsung Biologics that they cannot at other

development and manufacturing organization (CDMO), today hosted its second Supplier ESG Day to share insights on sustainable management and encourage ESG action among suppliers.Second of its kind, the event was held virtually to invite more domestic and global suppliers, with over 82 companies, including Merck, Cytiva, Thermo Fisher, and Sartorius, taking part.“As the healthcare industry is one of the largest carbon emitters, it is our responsibility to be at the forefront of efforts to promote sustainable value chains,” said John Rim, CEO and President of Samsung Biologics. “We will continue to support our suppliers to strengthen their ESG management and work together to build a greener and circular future.” Samsung Biologics shared its knowhow in ESG management and progress made so far. Aiming to achieve net zero by 2050, the global CDMO has been bolstering sustainable operations by utilizing low-carbon technologies, such as ultra-low NOx boilers and energy monitoring systems, and accelerating the transition to renewable energy by installing onsite solar panels. In recognition of its efforts, the company was awarded the Terra Carta Seal from the Sustainable Markets Initiative (SMI) and achieved a platinum rating from EcoVadis, the highest rank given. Samsung Biologics has been engaging suppliers, alongside global pharmaceutical companies, to decarbonize and build more resilient value chains as champion of the Supply Chains Working Group within the SMI Health Systems Task Force.Samsung Biologics also encouraged suppliers to contribute to building more sustainable global value chains, by staying ahead of various global reporting standards, including the European Union Corporate Sustainability Due Diligence Directive, European Sustainability Reporting Standards, and International Financial Reporting Standards.External ESG specialists were also invited to provide insights on ESG-related requirements and share sustainability reporting and disclosure tools applicable to small and mid-sized companies.

development and manufacturing.Read more

development, access to safe and effective payloads and linkers remains a challenge. Samsung Biologics is committed to empowering the ADC community by providing two novel payloads—derivatives of camptothecin and duocarmycin. These payloads boast best-in-class efficacy and safety, validated through extensive in vitro and in vivo studies. By offering these agents, we enable ADC developers to advance their research without financial burdens or the need for specialized medicinal chemistry expertise. In this webinar, we will introduce these innovative payloads and showcase how to integrate them into your ADC development through our "Easy to Access Technology" program. Gain valuable insights and explore real-world applications to elevate your projects.Key learning objectives:Importance of choosing high-quality payloads in ADC drug developmentPhysicochemical and biological characteristics of our novel payloadsHow you could test our payloads for your antibody under a simple arrangement

development could monitor subtle changes, such as variations in chamber vibrations, to predict when preventive maintenance is needed. These proactive approaches go beyond current preventive maintenance practices, allowing for timely intervention before issues arise Comprehensive drug lyophilization services Several critical factors should be considered when selecting a CDMO partner for lyophilization to ensure the process meets rigorous quality and efficiency standard. In this whitepaper, we explore the importance of the following five attributes for quality lyophilization services:Process expertiseAutomation and quality controlCapacity and equipment scalabilityRegulatory compliance and quality standardsRedundancy and reliability

development and manufacturing of live-saving biopharmaceuticals to give back to our local communities for social wellness and mutual prosperity.Since the company’s founding, Samsung Biologics has engaged in various programs to help those in need, such as supporting students with financial difficulties through scholarships and mentoring programs. Our employees have also been at the forefront of supporting the vulnerable through diverse volunteer programs. “Busy with daily life and work, people can easily forget that there are minorities that need help. Through this program, I realized that Samsung Biologics is not a company that seeks profit, but rather a responsible CDMO that cares about giving back to the society. I was happy to be a part of this campaign.” Jiyoung Bang, Global Media PartAs part of Samsung Biologics’ ongoing corporate social responsibility (CSR) initiative, the company held the ‘Nanum Week’ campaign (Nanum: Korean word for “giving”) where employees engaged in various volunteer and CSR activities. From November 1 to 14, over 600 employees extended a helping hand to others, either by making blood donations, volunteering at hospitals, or supporting patients at care centers.One group of employees visited a local hospital to hold a science class with young patients, giving them hands on experience of Thin Layer Chromatography (TLC). The young patients colored the filter paper with water-based ink pens, then dropped water on the paper, to watch the ink spreading and separating into different colors. "Chromatography is widely used in the purification process to manufacture biomedicines used to treat diseases these children are suffering from. They showed interest with smiles of joy from learning. It was a valuable experience for all of us, and I hope the children also had fun." Seunghyun Ahn, Tech Transfer groupThe course was organized to allow children to experience an educational environment.“I believe children are the future. So the wellness of children has always been my interest. This course was organized to allow children to experience an educational environment. I wanted to give them as much support as I can – therefore we put much effort into preparing this class. Considering the patients are young in their ages, we tried to make it as simple as we can, while delivering some scientific lessons and principles that are applicable to our business.” Geehyun Kwon, People Team Another group of employees visited a residence for people with severe disabilities, to assist the residents one-on-one while they take a walk – some of them in wheelchairs. Taking a walk is often something taken for granted in daily life. However, it is an invaluable experience for those with disabilities or limitations in moving around on their own. “To actually meet and spend time with disabled people was a turning point that influenced my perception greatly. Action speaks louder than words. This voluntary service made me realize that we, as employees working at Samsung Biologics, are producing drugs that really help people like them to live a better life. It is very grateful that I could support those in need in person.”Taewon Ahn, Information Security TeamSome employees decided to support others with just a touch of their ID card. Samsung Biologics operations ‘Nanum Kiosk,’ the kiosk that allows employees to make financial donations by tagging their ID cards. It is a convenient option for employees who are eager to help others even while they are at work. The kiosk is installed all across the company and displays the information of children who will get support from the donation. More than 10,000 donations are made through the kiosk, with over 10% coming from the Nanum week campaign.We always keep in mind that at the end of the day, what we do, what we manufacture, saves the lives of patients worldwide. Whether at work or outside of

development and manufacturing organization (CDMO), today announced a series of manufacturing deals with a Europe-based pharmaceutical company.The disclosed deals, worth over USD 668 million combined, will run through December 2031. The latest agreements bring up the company’s cumulative contract value for this year to more than USD 4 billion.“We are delighted to expand our partnership with the European pharmaceutical company toward our shared commitment to delivering high-quality biopharmaceuticals to patients,” said John Rim, President and CEO of Samsung Biologics. “As we further expand strategic collaboration with clients worldwide, we also make continued investments in our capabilities and manufacturing technologies. Our goal is to provide the highest-quality services at every stage and deepen our trusted partnerships.”The company has proactively addressed the evolving needs of clients with a series of significant deals this year, solidifying its customer base across the U.S., Asia, and Europe. Samsung Biologics has now partnered with 17 of the world’s top 20 pharmaceutical companies and continues to extend contracts with existing clients to support them in advancing innovative therapies.Samsung Biologics is set to add antibody-drug conjugate (ADC) services to its portfolio, with a dedicated facility to be completed by the end of this year. The company will provide a range of services, including ADC process development and conjugation, leveraging its comprehensive understanding of biologics and expertise in antibody manufacturing and engineering. Samsung Biologics will also see the opening of Bio Campus II next year, with Plant 5 on track to be operational in April 2025.

development.

development and manufacturing organization (CDMO) today announced it has achieved ISO 37301:2021 certification for the first time. The company also renewed certifications for upgraded ISO 27001:2022 and ISO 27017:2015 standards. The certifications were presented by the British Standards Institution (BSI) during a ceremony held at Samsung Biologics’ headquarters.The ISO 37301:2021, the leading standard for Compliance Management System, reflects the company’s commitment to enhance organizational governance and to comply with laws and regulations. Samsung Biologics operates a Compliance Program that promotes a culture of integrity and effectively address challenges in a rapidly evolving business environment as a reliable CDMO partner.The company also recertified to upgraded ISO 27001:2022 (Information Security Management System) and ISO 27017:2015 (Information Security for Cloud Services), displaying continued efforts to maintain the highest standards of information and cloud security as well as data protection for clients and stakeholders. ISO 27000 family is the most recognized global set of standards for managing information security and privacy management. Samsung Biologics has been implementing best practices and principles in accordance with the international standard to enhance client satisfaction and build further trust.“We’re pleased to obtain certification for compliance as it’s a recognition of our unwavering focus to meeting the highest standards to build deeper trust with our clients and strengthen business competitiveness,” said John Rim, CEO and President of Samsung Biologics. “Along with existing ISO certifications, we will continue to take the extra mile to strengthen ethical management while maintaining the highest security and privacy standards.”Samsung Biologics continues to be certified across other areas, including anti-bribery management, quality management, and business continuity management.

development and manufacturing organization (CDMO) offering flexibility and has advanced its molecules to Investigational New Drug (IND) approval and beyond. “We were highly confident that with Samsung Biologics we could meet our timelines to start clinical trials for two different formulations of the same product,” said Mary Cromwell, Chief Technical Officer at Allakos. “[Overcoming each project challenge,] I was overjoyed because Samsung was taking a risk and was able to meet our needs with the quality we expected.”Striding on the path to IND as one team with a sense of unity Allakos is a clinical-stage biotechnology company committed to finding cures for unmet areas of immune diseases, part of which have been reported to affect about one-fifth of the world population during a lifetime according to a study. The California-based biotech company is developing a Siglec-6 directed agonist monoclonal antibody (AK006) that suppresses and even kills targeted mast cells inducing allergic inflammation in humans.With a goal to achieve both speed and quality for its project to find cures for mast cell diseases where less than 10% of patients are on biologics, Allakos has partnered with Samsung Biologics to expedite the development of AK006 – moving it quickly from cell line development, to IND approvals, then finally into human trials. Advancing the route to IND per a desired timeline required scientists of both teams to embrace a shared understanding of goals, risks, and challenges, ultimately trusting one another through candid discussions. Such trust began to emerge from the beginning of the partnership and grew stronger as it progressed, eventually driving the team to overcome the time-sensitive formulation challenge.To increase dose quality and patient convenience in clinical trials post IND, Allakos needed Samsung Biologics to increase the target concentration level by 300%, initially from 50 mg/ml to 150 mg/ml. By adopting the client’s scientific expertise, the global CDMO developed an agile method outside the rim of its platform formulation. Aligned on goals of bringing high-quality doses to patients in future trials after passing through the last door before IND submission, the Allakos-Samsung Biologics team were able to remodel their formulation strategy together, implemented it, and finally managed to achieve the target concentration level in a condensed timeline. "The ability of scientists to have candid conversations with each other is critical to quickly drive projects forward and develop the right technical solutions," said Cromwell. "We had a great sense of unity with Samsung Biologics. They understood our challenges and worked alongside us to overcome any hurdles. This trust helped us advance the project much quicker, ultimately leading to development of the appropriate technical solutions we needed.”A sense of unity among scientists of both teams helped facilitate constructive debates, morphing each other’s arguments into a concerted solution.“Honest exchange of ideas and shared goals enabled the growth of a true partnership between Allakos and our development teams,” said Derrick Katayama, a lead formulation scientist at Samsung Biologics. “Identifying technical strategies to achieve a higher concentration level in a short timeline was definitely challenging. However, leveraging resources from both parties enabled a successful development program. It was a wonderful and enriching experience working with all members of the Allakos project team.”Flexibility for CDMOs means assessing issues from the client’s perspective, leveraging every resource to find solutions, and executing joint solutions in time to support the client’s commitment to patients.“[The way Allakos and Samsung Biologics resolved the formulation challenge was] an excellent example of the two companies working closely together for a shared outcome of developing the increased concentration that goes into people,” said Cromwell.Trusted CDMO partner offerin

development by integrating technology innovations from adjacent industries. In this roundtable article, Heejeong Kim, Vice President and Head of Drug Substance Manufacturing, shares insights into the industry's adoption of digital twin technology to enhance operational excellence.Read more

development, achieve the highest quality, and flexibly meet clients' goals.Read more

development and manufacturing organization (CDMO), today announced financial results for the third quarter of fiscal year 2024."We made steady progress this quarter, achieving consistent performance across all our plants while expanding our capabilities to better address the needs of our clients," said John Rim, CEO and President of Samsung Biologics. "As we continue to enhance our CMO technologies and introduce new CDO platforms, we remain committed to providing high-quality, innovative solutions that are essential for development and manufacturing success maximized through our unique operational excellence initiatives. This will reinforce our efforts to deepen our global partnerships and enhance the value we offer to our clients." THIRD QUARTER 2024 RESULTSIn the third quarter, consolidated revenue reached KRW 1.2 trillion, marking a 15% increase compared to the previous year, while operating profit stood at KRW 338.6 billion. On a standalone basis, the company achieved revenue of KRW 1.1 trillion, while operating profit reached KRW 444.7 billion. The quarter’s results were buoyed by the contribution of the newest Plant 4 and the full utilization of Plants 1 through 3.[Consolidated Earnings, KRW billion] Q3’24Q3’23YoY ChangeRevenue1,187.11,034.0+153.1(+14.8%)Operating Profit338.6318.5+20.1(+6.3%)EBITDA495.4457.1+38.3(+8.4%) Samsung Biologics has strengthened its partnerships with global pharmaceutical companies, now collaborating with 17 of the top 20 pharma clients. The total contract volume for 2024 has exceeded USD 3.3 billion, with a cumulative contract volume of USD 15.4 billion. The company has achieved over 335 regulatory approvals since its founding in 2011, demonstrating its commitment to high standards of quality and compliance. FISCAL YEAR 2024 OUTLOOKSamsung Biologics has raised its annual revenue growth guidance to 15-20%, driven by the successful ramp-up of Plant 4 operations and favorable foreign exchange rates. The company continues to make steady progress on key strategic initiatives, including the construction of its dedicated, standalone ADC facility by the year’s end, along with Plant 5, scheduled to be operational in April 2025.The company is also poised to delivering solutions that better cater clients’ needs for complex and high-concentration biopharmaceuticals. Recent development platform launches — S-AfuCHO™, S-OptiCharge™, and S-HiCon™ — provide advanced capabilities, from generating afucosylated antibodies with enhanced ADCC activity to optimizing charge variant distribution for improved safety and efficacy. These technologies are designed to support the growing demand for complex biopharmaceuticals and enable clients to achieve their therapeutic goals.Looking ahead, Samsung Biologics expects to gain further momentum through enhanced capabilities and the expansion of manufacturing partnerships with leading pharmaceutical and biotech companies. The company continues to invest in innovative companies with promising technologies to accelerate the delivery of advanced solutions through the Samsung Life Science Fund. Samsung Biologics is committed to further integrating sustainable practices throughout its operations. In August, the company joined the Pharmaceutical Supply Chain Initiative as a Supplier Partner. This partnership complements Samsung Biologics' role within the Sustainable Market Initiative’s Health Systems Task Force to decarbonize supply chains. Moving forward, the company will prioritize responsible business practices and build resilient supply chains that contribute to a sustainable healthcare ecosystem.For more details on performance and financials, please refer to the Earnings Release.

development and manufacturing organization (CDMO), announced today a contract manufacturing deal with an Asia-based pharmaceutical company.The disclosed deal, worth USD 1.24 billion, is the largest contract signed by a single client. Production will take place at Samsung Biologics’ biomanufacturing site in Songdo, South Korea and the contract runs through December 2037. With the latest agreement, the company’s accumulated contract for 2024 surpasses USD 3.3 billion.“We are pleased to strategically collaborate with the Asia-based pharmaceutical company to bring effective, high-quality biopharmaceuticals to the global market,” said John Rim, President and CEO of Samsung Biologics. “The deal comes at a significant time as we proactively build on our biomanufacturing capacity to readily support our clients. Leveraging our capabilities and proven expertise, we plan to maintain momentum for further expansion by fostering trusted and sustainable partnerships with potential and existing clients for mutual growth, and ultimately help patients with unmet needs.”Samsung Biologics has now to date partnered with 17 of the world’s top 20 pharmaceutical companies, and continues to expand its customer base to key regions, including Japan. In addition to sales offices in the U.S., the company is planning to open a regional office in Tokyo to further enhance relationships with clients.Samsung Biologics is on track to complete the construction of a dedicated ADC facility by the end of this year. A fifth plant is set to be operational in April 2025, adding a fresh capacity of 180 kL, for a total of 784 kL across Plants 1 to 5. To help clients better address emerging health challenges and improve the lives of patients, the company continues to launch innovative CDO platforms and implement manufacturing technologies to support complex projects, including the development and production of multispecifics.

development scientists discuss the latest advancements in IFB processing and how our S-Tensify™ platform ensures consistent quality and productivity.Key Takeaways:Learn how Samsung Biologics integrated intensified fed-batch (IFB) processing to achieve higher densities of viable cells during the N-1 step.Discover how Samsung Biologics’ IFB platform, S-Tensify™, optimizes cell culture processes, enhancing yield and material quality.Explore case studies that demonstrate a 30-fold increase in inoculation cell density using the S-Tensify™ platform.

development all the way to investigational new drug (IND) submission, Samsung Biologics has a track record of successfully bringing fusion proteins and other complex molecules to preclinical testing. With uncompromised quality serving as a guiding principle during each step of the global CDMO’s development services, deep understanding of a molecule based on a robust in-house database assures clients of timely solutions.Fusion proteins can bring together two types of cells, a cancer cell and an immune cell for example, boosting the ability of the immune cell to target the cancer cell in close proximity. The molecular bridge in this instance consists of different antibodies fused together. A longer half-life also makes fusion proteins highly sought after in clinical settings for their lasting therapeutic effects in the body.With the global market estimated at over $55 billion by 2030 compared to $24 billion last year1, fusion protein medicines selectively combine the beneficial parts of what single proteins offer on their own and promise wide-ranging applications. With a fifth of IND submissions at Samsung Biologics dedicated to bispecific antibodies and fusion proteins, every step of the CDMO’s complex molecule biomedicine development is upheld by dual pillars: technological innovation and flexible, transparent communication with clients.For any biologic modality, a molecule’s efficacy in vivo depends on scientific tools that take advantage of cells’ transcription mechanisms. Using the Transposase system, Samsung Biologics’ cell line development (CLD) and upstream processing (USP) teams achieve high titer while maintaining product quality of fusion proteins, including those influenced by glycans, sialic acids, and charge variants – critical quality attributes (CQAs) to be monitored. Using S-TensifyTM, the teams also boost productivity of the cell culture, contributing to titer.Hand-in-hand with or arguably more important than titer, however, is quality of the product according to senior CLD scientist Byungseok Choi. The CLD team uses a high-throughput lectin assay along with total sialic acid contents (TSAC) analysis to determine sialic acid levels during clone screening, which pave the way for quality-assuring measures. “We are continuously researching novel methods of clone screening and cell culture, including perfusion to remove used media and unwanted byproducts,” said Junyong Park, a lead scientist in USP Development. To enhance and fine-tune product quality throughout the upstream process, the USP team has also established S-GlynTM and S-OptiChargeTM platforms.Coupled with scientific tools is organic communication with the client providing the molecule for development services. During times when the client needs guidance on better understanding of their molecule, the CLD and USP teams take part in a regular back-and-forth to share resulting timeline changes, according to Sanghyeop Choi, a senior scientist in Next Generation CLD. This is particularly relevant for toxicology studies scheduled in advance.Following the CLD and USP steps, challenges may arise as subsequent processes unfold to yield the active pharmaceutical ingredient (API). As fusion proteins are prone to fragmentation, they are more likely to aggregate than monoclonal antibodies. This ultimately leads to unwanted entrapment of proteins in the cell’s Golgi apparatus, preventing secretion of naturally folded proteins and causing premature degradation. Therefore, efforts to raise titer have proven to be counterproductive, as they simultaneously compromise purity of the API. As a means to directly address this challenge, the DSP team has established their working system for removing impurities from extracted proteins. Initial steps of the procedure are facilitated through in silico analyses of different physico-chemical properties, which help to efficiently select more favorable resins from an established li

development and manufacturing organization (CDMO), launched today a new high-concentration formulation platform to support the development and manufacturing of high-dose biopharmaceuticals.S-HiConTM can proactively identify unintended pH changes, enhance formulation stability, and reduce viscosity to ensure efficacy and maximize drug delivery. Through optimization of pH, buffer species, and excipients, along with a preliminary ‘Concentration Gate Check’ process, the platform tests formulation feasibility in the initial stages to identify favorable candidates and minimize potential risks associated with high concentration development. Additionally, S-HiConTM integrates analytical capabilities to ensure that critical formulation challenges associated with viscosity and protein aggregation are addressed (Figure 1). Samsung Biologics has recorded over 200 mg/mL for liquid formulations, with adequate viscosity and improved stability. viscosity by concentrationConcentration 1, Concentration 2 9.6cP - Figure 1. Composition can impact the viscosity of the formulation. At the highest concentration measured, a difference of ~ 9.6 cP is observed between the two formulations.“Our new platform will enable us to provide innovative solutions for clients requiring low to ultra-high concentration formulation to develop advanced therapeutics,” said Brian Hosung Min, Executive Vice President and Head of CDO Development. “Samsung Biologics is committed to providing customized services by leveraging our expertise and track record in contract development.”The latest offering is part of Samsung Biologics’ continued efforts to provide clients with innovative technologies that enable high-quality development. Leveraging platforms that can increase antibody-dependent cellular cytotoxity (ADCC) activity and enhance upstream process quality, the company is expected to better accommodate clients’ evolving needs and support their pipelines. Visit our website to learn more about our CDO platforms: https://samsungbiologics.com/services/cdo/overview

This webinar discusses the challenges of developing high-concentration biopharmaceutical formulations, such as increased aggregation, viscosity, and opalescence. It also presents case studies on how to manage these issues and practical strategies for streamlining the formulation process, with a focus on enabling subcutaneous administration for patient convenience.Key learning objectives:Understand challenges in developing high-concentration biopharmaceutical formulations.Discuss fundamental formulation principles and tools for successful high-concentration formulations.Explore Samsung Biologics’ practical strategies for developing high-concentration formulations.Small-scale tangential flow filtration to understand pH shiftSmall-scale spikes to understand feasibility of achieving spikes and provide final pH/osmolality of the final formulationEvaluation of screening methods for high-concentration formulations — HIAC dilution and SEC dilution