Development, shares insights on how Samsung Biologics conducts rigorous assessments to address such obstacles during the formulation processes.Read more

development (CLD) technologies, challenges remain due to the complex structure of each molecule. In this article, James Taylor, our senior CLD scientist, discusses how we navigate the complexities to meet intricate molecule specifications, maintain regulatory compliance, and promote sustainability. Read more (45-47P)

development platforms – S-AfuCHOTM and S-OptiChargeTM – at BioProcess International 2024 - New technology platforms to proactively address evolving industry trends and enable high-quality developmentIncheon, S. Korea, September 25, 2024 – Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), launched today a series of proprietary development platforms as part of continued efforts to ensure high-quality development and provide client-tailored services. S-AfuCHOTM, introduced at BioProcess International 2024, is a cell line platform that can generate afucosylated antibodies that exhibit enhanced antibody-dependent cellular cytotoxity (ADCC) activity for increased therapeutic efficacy. The platform removes the core fucose from Fc N-glycans through knockout of the host (FUT8) gene to achieve higher ADCC activity while retaining desired titers, stability, and product quality (Figure 1).S-OptiChargeTM is an upstream process platform that can modulate a molecule’s charge variant distribution. Modifications can occur at any step of the manufacturing process, impacting product safety and efficacy. The platform minimizes charged variants within samples while maximizing the main molecular form to ensure safe therapeutic effects. By optimizing media, additives, and process parameters and using a thorough screening procedure, S-OptiChargeTM ensures high product quality through tight control over critical quality attributes to achieve optimal charge variant distribution (Figure 2).“Our new platforms are expected to provide clients with high-performing solutions for their molecules to reduce risks and support successful development,” said Jahoon Kang, Vice President of CDO at Samsung Biologics. “We will continue to develop innovative solutions to proactively address the evolving needs of our clients and meet increased demand for complex and high-concentration biopharmaceuticals.”Samsung Biologics is currently showcasing its latest CDO capabilities and expansion plans for Bio Campus II at BPI Boston that runs through September 26. For further information, please get in touch with a representative at booth #1025 or visit https://samsungbiologics.com/services/cdo/process-development. About Samsung Biologics Co., Ltd.Samsung Biologics (KRX: 207940.KS) is a fully integrated, end-to-end CDMO service provider, offering seamless development and manufacturing solutions from cell line development to final aseptic fill/finish as well as laboratory testing support for the biopharmaceutical products we manufacture. Our state-of-the-art facilities are CGMP compliant with bioreactors ranging from small to large scales to serve varying client needs. To maximize our operational efficiency and expand our capabilities in response to growing biomanufacturing demand, Samsung Biologics completed Bio Campus I with Plant 4, offering a combined 604 kL total capacity, and launched Bio Campus II with the construction of Plant 5, which will be operational in April 2025, adding 180 kL biomanufacturing capacity. Additionally, Samsung Biologics America enables the company to work in closer proximity to clients based in the U.S. and Europe. We continue to upgrade our capabilities to accommodate our clients by investing in technologies such as an antibody-drug conjugate (ADC) facility, a dedicated mRNA manufacturing facility, and additional aseptic filling capacity. As a sustainable CDMO partner of choice, we are committed to on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise.

development while allowing for precise tuning of charge profiles to meet the target quality specifications of therapeutic proteins.

development process.”Proven track record and expertise in facility design and engineeringFrom years of experience, Samsung Biologics has refined its facility design methodology to minimize inefficiencies, reduce costs, and shorten project timelines. Our comprehensive strategy encompasses all facility development phases—from design and construction to operational readiness—ensuring each manufacturing site is ready to efficiently produce high-quality biopharmaceutical products.Samsung Biologics successfully completed four large-scale plants, demonstrating a strong ability to manage complex projects effectively. The company is currently building Plant 5, the first facility of Bio Campus II, whichwill be operational by April 2025. The construction timeline is expected to be approximately 30% shorter than the 35 months taken to complete Plant 3, which has the same capacity. The shortened timeline underscores the company’s expertise and commitment to expanding manufacturing capabilities to meet diverse and immediate client needs.Advanced engineering and estimation tools are crucial for meticulously planning facility development, including material and utility requirements, project timelines, and cost estimates. Using these tools and a project management information system for real-time management, Samsung Biologics significantly reduced the risk of cost overruns and delays, allowing for efficient resource allocation, benefiting the company and our clients.Samsung Biologics continuously improves facility design, construction, and validation methodologies. Each new plant implements best practices and the latest regulatory requirements, optimized for operational excellence. The Engineering, Procurement, Construction, and Validation(EPCV) Team uses historical data from past projects for feasibility studies, gap analyses, and capital expenditure estimations to deliver customized solutions that meet clients’ needs. Innovative strategies for enhancing efficiencySamsung Biologics will adopt the standardized design at Bio Campus II, starting with Plant 5, to enable seamless scaling across multiple projects. This modular manufacturing model will accelerate construction timelines, enhance operational efficiency, and allow for agile adaptation to varying project requirements. By replicating proven designs and processes, Samsung Biologics can scale operations efficiently while maintaining the highest standards of quality and reliability. To be more flexible and efficient, Samsung Biologics employs an optimized downstream processing strategy that enables the simultaneous processing of multiple batches or different products. This is especially efficient for complex molecules or products that require longer processing times. Minimizing bottlenecks and ensuring continuous operation enables agile responses to changing production demands, maximizing throughput while ensuring quality and speed to market for clients.“Having manufactured thousands of batches and developed hundreds of products, we have built a robust knowledge base that helps us anticipate challenges and develop cost-effective solutions,” explains Yujin Kim, an engineer in our Engineering Planning Group at Samsung Biologics. “Our focus on continuous improvement and innovation ensures that we are always advancing our capabilities to better support clients.” Commitment to quality and client successSamsung Biologics emphasizes quality excellence as well as client satisfaction, and we continue to build on our facility development capabilities to exceed industry standards. The company is committed to providing clients with the utmost flexibility and reliability so they can quickly bring life-saving medicines to patients worldwide.Samsung Biologics remains steadfast in its commitment to enhance manufacturing capabilities and provide innovative technological solutions. Additionally, the company will closely monitor its clients’ divers

development. In our latest whitepaper, Heonchang Lim, Director of Formulation Development, explains how we leverage our proprietary DEVELOPICK™ platform to streamline the discovery process, enhancing the likelihood of successful drug commercialization.

development of new treatments, is forecast to have a compound annual growth rate of 9.5% during the 2024-2030 period [source]. And the number of multispecific antibody medicines in clinical development is predicted to grow from 900 currently to over 1,200 [GlobalData] [source]. While multispecifics can present challenges in manufacturing due to their elaborate molecular structure, Samsung Biologics offers strengths in agility, flexibility, operational excellence, technology innovation, and timely capacity expansions to support clients’ complex manufacturing needs. Committed to meeting clients’ manufacturing timelinesSamsung Biologics has an extensive track record in meeting production timelines. Two bioreactors for each train in the CDMO’s most recently constructed biomanufacturing plants – also to be the case for upcoming plants in BioCampus II – enable short production turnaround times and allow for agile project execution.Powered by such agility, a recent multispecific antibody manufacturing project at Samsung Biologics received successful process performance qualification (PPQ). “Starting from due diligence prior to the kick-off meeting, we set up processes based on a facility fit assessment and mass balance analysis,” said Joomyung Lee, Lead Engineer and Director of the Purification Group in one plant. “Through organic collaboration between the client and our manufacturing science and technology (MSAT), manufacturing, and corporate engineering teams to address any gaps in the process, we successfully kept to the timeline for introducing all necessary equipment for the project.” Jeongsoo Lee, Senior Scientist in the plant’s Tech Transfer Group, said: “We had to separate parental materials of the multispecific product even though they underwent the same processes when being manufactured. We did this by running the processes on separate trains, achieving successful segregation and cadence.” Optimized timelines for validation and vendor management also pave the way for agile execution of projects. “Thanks to the close collaborative relationship formed with our vendors during plant capacity expansion by our purchasing and procurement department, we were able to successfully complete the introduction and authorization of new equipment on time,” Joomyung said. His group completed the design, procurement, and validation of the ultrafiltration / diafiltration (UF/DF) skid in a shorter time than the conventional lead time suggested by the vendor. Flexible processes and facility fitAlso of note has been the CDMO’s flexibility. Designed to fit processes for diverse complex molecules, Samsung Biologics’ facilities minimize delays caused by product change-over and suboptimal production cadence.“To accommodate diverse complex molecules and processes, we have additional main equipment, utility, and supporting equipment necessary to proceed with setups apart from those used for conventional antibody processes,” said Joomyung. “There were many unit processes and required equipment compared to regular processes, but we had the flexibility to carry this out. On top of the engineering and construction capabilities for independent modification of our plants, we had the flexibility and automation needed for introducing new sensors.” Commitment to operational excellence and technology innovationsEqual in importance as Samsung Biologics’ flexibility is its commitment to upholding high standards in operations. Validation and maintenance can introduce hurdles at any step, but the CDMO’s risk-based and phase-appropriate approaches help root out inefficiencies. The multispecifics project required the preparation and combining of parental antibodies for bispecific antibody formation, prior to entering the downstream process for conventional monoclonal antibodies. The unit process of thawing the parental materials from t

development of a drug product, encompassing every stage from initial formulation to final production. Read this article to learn how our tailored CMC service, SelecTailor™ can accelerate your projects and enhance your development efficiency.Read more

development timelines and enhance quality. Kevin Sharp, Senior Vice President and Head of Global Sales, shares his insights on industry trends and our latest business developments in this BPI Theater interview. Read more

development landscape, partnership between innovative biopharmaceutical companies and resource-rich CDMOs is vital for ensuring global access to essential medicines. In these roundtable discussions, our project manager, Jaewon Mun offers her insights on how advanced technologies and customizable models enable CDMOs to provide enhanced support throughout the drug development life cycle, ultimately driving client success.Read more

development cycles while maintaining high quality across various therapeutic modalities.

Development, shares her insights on the challenges and emerging trends in ADC development, drawing from her extensive experience.Read more

development to aseptic fill/finish on meeting timelines and handling regulatory hurdles, the global CDMO seeks to eradicate any chance of human error in collecting or analyzing clients’ project data, thereby preserving data compliance. Drug development/manufacturing projects require continuity, consistency, and standardization of data work. Samsung Biologics’ digitized system is embedded with those requirements, facilitating collaboration between the CDMO and its client to induce a data-driven solution. Data continuity and consistency allow tracing back records generated during development processes to identify the root cause of an issue encountered while manufacturing CGMP products. Also, standardized data-gathering processes through serialization ensure consistent data labeling regardless of its origin and thus save time once required for hand-filtering and querying data. Process optimization via MES has been tried across manufacturing industries to unearth problems faster and strategically implement corrective actions. The biopharmaceutical industry, a relative latecomer in terms of adopting MES, is catching up fast, but not fast enough to keep up pace with the evolving biologics market. “Much of the data work is still done by hand in the biopharmaceutical industry,” says Kwon. “But the industry also recognizes the need for accelerating the transition from hands-based to data-based information gathering, as the market demands rise for complex biologics, like bispecific antibodies and antibody-drug conjugates.” If a CDMO doesn't provide clients with such an integrated system, they would be left vulnerable to losing meaningful manufacturing data that would have been critical for assessing quality in subsequent stages, says Kwon. Robust digital fundamentals in place Recent studies, like one via the Journal of Generic Medicines, have spotlighted the use of MES in biopharma operations as a base tool for operational excellence, which would bring reduced production cycles, fewer failed batches, regulatory compliance, and stringent execution of *ALCOA principles in daily operations. All told, MES builds groundwork before incorporating artificial intelligence or machine learning-based technologies into the biopharma systems, the studies say.*ALCOA: A set of principles for data compliance in life sciences – Attributable, Legible, Contemporaneous, Original, & Accurate Digital connectivity, an umbrella term for MES, is what Samsung Biologics offers its clients. It not only holds the CDMO accountable but also propels the company to bring transparency in every facet of operations, says Kwon. With strong digital fundamentals under its belt, Samsung Biologics provides a correlated set of data to its clients, enabling them to leverage digitally-sorted data and develop timely solutions. Having digitized every end-to-end data in one system also enables the global CDMO to provide any data requested from its clients when they need. “Our own digital system, we believe, is best for bringing process optimization and satisfaction to our clients,” Kwon says. Digital transformation at Samsung Biologics is continuously being innovated as the global CDMO believes there is always a process to improve upon. In tandem with the expansion of capacity and business portfolios, Samsung Biologics continues to find ways to better support its clients with their commitment to patients.Related contentsMedia Focus Pharma 4.0: CDMOs Digitalize to Enhance Customer ValueWhitepaper Partnerships for Success | Trust empowers a CDMO and its partner to grow together and achieve shared goals

development and manufacturing organization (CDMO), announced today that the company has joined the Pharmaceutical Supply Chain Initiative (PSCI) as a Supplier Partner.Samsung Biologics is the first Korean CDMO to participate in the PSCI, a group of pharmaceutical and healthcare companies that share a common vision of excellence in safety, environmental, and social outcomes across the global healthcare value chain. Samsung Biologics will commit to PSCI principles that address five areas of responsible business practice – ethics, labor, health & safety, environment, and management systems.Samsung Biologics expects the partnership to help further advance the company’s steadfast dedication to sustainable growth and strengthen its Environmental, Social, and Governance (ESG) management. As part of its efforts to decarbonize and build more resilient supply chains, Samsung Biologics has been engaging suppliers as champion of the Supply Chains Working Group within the Sustainable Market Initiative’s Health Systems Task Force.“We are pleased to join the PSCI and hope to actively support collective actions to improve supply chain management,” said John Rim, CEO and President of Samsung Biologics. “As part of our commitment to deliver safe, high-quality biomedicines, we will incorporate PSCI principles into our business practices and promote responsible conduct among our suppliers to drive sustainable change across the supply chain, contributing to a healthier future.”

The implementation of a Quality-by-Design (QbD) approach enables drug developers to construct more robust processes and analytical methods, resulting in high-quality pharmaceuticals. This whitepaper explores how we thoroughly manage sources of variability inherent in the process and mitigate risks to support streamlined and standardized production.

development and manufacturing organization (CDMO), announced today its financial results for the second quarter of fiscal year 2024."Our solid performance in the second quarter underscores our steadfast commitment to client satisfaction and delivering high-quality biomedicines," said John Rim, CEO and President of Samsung Biologics. “We continue to achieve steady business growth thanks to our robust partnerships with global pharma and biotech companies, and our steadfast execution of Plant 4 ramp up. We remain well-positioned to meet client needs as we continue to expand capacity and enhance our capabilities.”SECOND QUARTER 2024 RESULTSIn the second quarter, consolidated revenue reached KRW 1.16 trillion, while operating profit stood at KRW 434.5 billion. On a standalone basis, the company achieved a revenue of KRW 810.2 billion, while operating profit came to KRW 329.2 billion during the same period.The results were driven by the full utilization of Plants 1 through 3 and the ramp-up of Plant 4 operations. Samsung Biologics also secured contracts with global pharma, partnering with 16 of the top 20 global pharma companies. The company’s cumulative contract volume surpassed USD 13 billion as of June.In line with the company’s commitment and vision to innovation and growth, Samsung Biologics continued to make strategic investments into diverse modalities. In May, the company made its sixth investment through the Samsung Life Science Fund in Latus Bio, a US-based biotech company specializing in novel gene therapy for central nervous system disorders.The first half of 2024 saw consolidated revenue of KRW 2.1 trillion and an operating profit of KRW 655.8 billion.[Consolidated Earnings, KRW billion] Q2’24Q2’23YoY ChangeRevenue1,156.9866.2+290.7(+33.6%)Operating Profit434.5253.4+181.1(+71.4%)EBITDA582.6362.1+220.5(+60.9%) FISCAL YEAR 2024 OUTLOOKSamsung Biologics is on track to completing the construction of its standalone ADC facility within this year, as part of its multi-dimensional growth strategy. Additionally, Plant 5 is expected to be operational by April 2025 as planned, enabling the company to provide additional capacity to deliver timely services to clients. On the CDO front, Samsung Biologics continues to launch new innovative platforms to accelerate the development of high-quality biopharmaceuticals. The company also offers customized development solutions, dubbed SelecTailor™, which are tailored to meet the specific needs of clients and support their programs. As part of efforts to foster emerging biotech companies and seek new growth engines, Samsung Biologics, along with Samsung C&T, Samsung Bioepis, and Samsung Venture Investment, established the Samsung Life Science Fund II in July. The fund will invest in Flagship Pioneering Fund VIII, which is managed by U.S. based biotech investment firm Flagship Pioneering and focuses on investing in artificial intelligence-based drug development platform technologies.Samsung Biologics remains steadfast in its commitment to embed sustainability across business operations. Last month, the company released its annual ESG report, highlighting its progress in business resilience and sustainability. The company will continue to adhere to global ESG disclosure regulations as well as implement measures to achieve carbon neutrality targets.

development of next-generation biologics. Read more

Development, discusses how QbD effectively addresses potential variability and risks, thereby optimizing processes and ensuring successful development outcomes. Read more

Development, will introduce DEVELOPICK™, the company’s robust developability assessment tool. Schedule a meeting in advance with the Samsung Biologics team, and learn more about how we can support your development and manufacturing goals: https://partner.samsungbiologics.com/bioplusinterphexkorea2024

development and manufacturing organizations (CDMOs) and drug developers is essential. It enables CDMOs to adopt a client-centric mindset and allows drug developers to focus on bringing innovative drugs to patients without concerns about potential misalignment with their partners. Since its founding in 2011, Samsung Biologics has developed trust with its global partners through the “Samsung Biologics Way,” which is defined by four pillars of excellence. The Four Pillars of Excellence The pillars span four areas of excellence: customer, operational, quality, and people. Each pillar supports the others, creating a cohesive framework that ensures every aspect of CDMO operations is focused on achieving and maintaining client satisfaction and success. Customer Excellence Transparency, which facilitates proactive knowledge sharing between CDMOs and their partners, is the backbone of client excellence. By centering daily operations and business development plans around client needs, CDMOs can effectively drive client success. Operational ExcellenceAn ongoing commitment to optimizing processes and standardizing systems for efficiency and data integrity is crucial for client satisfaction. Operational excellence enhances CDMOs’ ability to solve problems, safeguard the drug development life cycle, and ensure timely delivery of drugs to patients. Quality Excellence A quality mindset and culture ensure that client programs stay compliant with evolving regulations. The best approach for CDMOs to maintain the necessary compliance is to integrate quality-by-design (QbD) principles from the start. By operating according to QbD principles, CDMOs can maintain robust data integrity, enable timely problem-solving when issues arise, and ultimately help clients overcome regulatory hurdles without delays. People ExcellenceA commitment to the continuous improvement of employee skills and abilities builds client trust that a CDMO is always ready to address their needs. With a focus on the future, CDMOs should invest in the ongoing development of their employees, ensuring they are prepared for today's challenges while also fostering tomorrow's innovations. The four pillars are the very cornerstone of a trusted partnership. Values drug developers seek from their CDMO partners—such as transparency, accountability, and shared goals—come from CDMO operations driven by the four pillars. Such operations start with putting the client first and staying in step with what the partner needs now and will need down the road. Then, it's about getting the day-to-day right — smooth operations where clear communication and data handling mean fewer mix-ups and more forward momentum. Quality can't be an afterthought: It's always kept in focus, making sure every step moves things ahead to prepare for what regulators will demand. Of course, none of this works without the right people — who keep learning and growing and are ready to tackle any task. This solid base enables drug developers to stay focused on the big picture: researching, funding, and guiding their product through the regulatory process while holding firm trust that the CDMO is handling the rest of the development and manufacturing considerations. Promises Delivered, Satisfaction Met Since its founding, Samsung Biologics has cultivated a tenure of trusted partnerships with over a hundred global drug developers, advancing their mission to bring innovative treatments to patients. Samsung Biologics understands that drug developers navigate numerous clinical challenges and therefore require timely assistance from trusted partners to keep their development projects on track. This is why Samsung Biologics aligns its growth strategy, including capacity and portfolio expansion, with the goal of supporting its partners’ current and future projects. This ensures timely and reliable support whenever needed. In 2021 Bolt Biotherapeutics, a California-based biotech, was looking for a reliable CDMO partner to develop a dr

development and manufacturing organizations (CDMOs) to advance their projects. Selecting a CDMO with expertise in linker and payload technologies, along with facilities for cytotoxic drug product manufacturing, is essential to propel a program forward. With a stellar track record of success as a trusted CDMO partner, Samsung Biologics is able leverage its extensive expertise in antibody manufacturing, antibody engineering, and large-scale production, as well as cutting-edge facilities to play a pivotal role in ADC production.Integrated expertise and cutting-edge technologySamsung Biologics’ commitment to advancing ADC development is demonstrated through ongoing investments in its development and manufacturing capabilities. The company’s new ADC facility is designed to support the entire spectrum of ADC production, from pre-clinical to commercial manufacturing. Equipped with state-of-the-art facilities and cutting-edge technologies, Samsung Biologics is uniquely positioned to meet the intricate demands of ADC manufacturing at a single site. Manufacturing highly toxic biomedicines at a single location reduces containment risks by centralizing specialized facilities and expertise. It also minimizes transportation time and distance, streamlines the supply chain, and fosters focused research and development, leading to consistent product quality and innovation. This integrated approach ensures Samsung Biologics’ ability to offer a seamless, comprehensive ADC development program, effectively addressing key challenges. “The complex requirements for ADCs often rely on a fragmented supply chain; therefore, it can be challenging to ensure consistent quality controls, synchronized timelines, and efficient communication across various vendors. By using a single CDMO partner, clients can simplify supply chain logistics and adopt a robust approach to eliminate bottlenecks, resulting in reliable and consistent production.” said Yoonjin Kwon, Lead Scientist in Analytical Development and a member of the company's ADC Task Force. 4F Future Space3F Laboratories2F Conjugation1F Utility & LogisticsThe facility features a flexible design accommodating both single-use and stainless steel options, capable of scaling production up to 500 liters to meet diverse client needs. It is equipped to handle Highly Potent Active Pharmaceutical Ingredients (HPAPIs), antibodies, and complex linkers with precision. Advanced isolator technology ensures stringent exposure management, safeguarding both product integrity and personnel safety, while meeting stringent occupational exposure limit (OEL) requirements for GMP production of clinical and small-scale ADC batches.“We manage components (payload, linker and antibody) of the ADC through consistent quality and rigorous analytical development—every step of the way is validated and tested to ensure patient safety. That is always our top priority,” Kwon added. Samsung Biologics’ commitment to innovation extends beyond its facilities and technologies. Through strategic investments through the Samsung Life Science Fund, the company is supporting Araris Biotech AG for their linker-payload toolbox and conjugation technology, as well as AimedBio for their ADC pipelines. Samsung Biologics has a partnership with LigaChem Biosciences to develop and manufacture antibody for their ADC program. These collaborations underscore Samsung Biologics’ dedication to further build on the company’s competitive edge and contribute to shaping the future of healthcare through the development of next-generation biomedicines. In line with Samsung Biologics’ mission to create a healthier world through high-quality biomedicines, the company hopes to offer new hope for patients with its latest portfolio expansion. Samsung Biologics’ evolving capabilities and integrated approach will help enable the company to address the key challenges of ADC development and manu

development and manufacturing organization (CDMO), has expanded its capacity more than 20 times within just over a decade. Behind its unprecedented business growth strategy was a mission to become a trusted partner to those developing critical and life-saving drugs worldwide. Earning trust from global biopharmaceutical companies wasn’t easy. The CDMO needed to steadfastly nurture service flexibility and a quality mindset, as well as continuously enhance its operational excellence.

development, a CDMO partner that has the capacity and expertise to support the entire drug journey is crucial for success. In this Outsourced Pharma Capacity Update presentation on May 21 at 10 AM (ET), Thomas Rohrer, Senior Director of Bioconjugate Technology Support, will discuss Samsung Biologics’ comprehensive service offerings as well as expansion into the ADC space. Register now:

development, and uphold the value of life. “Creating a positive corporate culture is not just the right thing to do, but essential for business success and client satisfaction,” John Rim, CEO and President of Samsung Biologics. “I will be at the forefront of efforts to foster a mature and inclusive culture, where employees can grow and find value.”

development method enables the safe and efficient development of molecules in compliance with regulatory requirements. This webinar, where Steven Lal, lead CDO analytical scientist, will share insights on our capabilities and case studies for our new offerings, Host Cell Protein (HCP) identification and Sequence Variant Analysis (SVA).

development pathways, CDMOs must continue to increase efficiency in existing processes to enable faster delivery while maintaining quality.Read More

developments regarding capacity expansion and portfolio diversification. The Samsung Biologics team was also able to network with existing and potential clients throughout the four-day event.The Samsung Biologics team greets visitors at its boothAt its eye-catching booth, Samsung Biologics showcased its client-centric service value – Agile. Flexible. Focused on You. – reflecting the company’s commitment to offer tailored and seamless solutions with accelerated timelines for its clients. Samsung Biologics introduced S-TensifyTM – the latest addition to its series of proprietary technology platforms. It is an intensified cell culture platform designed to support the development of high-concentration biopharmaceuticals.The company also shared updates regarding Plant 5 and its antibody-drug conjugate (ADC) facility. Plant 5, the first facility of Bio Campus II, will add fresh capacity of 180,000 liters when operational in April 2025 – giving Samsung Biologics a total biomanufacturing capacity of 784,000 liters. The construction of the company’s ADC facility is also expected to be complete by the end of the year.Samsung Biologics’ booth also had private space to facilitate meetings with existing and potential clients to learn more about the company’s offerings and discuss collaboration opportunities in manufacturing and development.Samsung Biologics’ booth attracts visitors at BIO 2024Private lounge located within Samsung Biologics’ booth to facilitate client meetingsCorporate brochures downloadable via QR codes as part of sustainability effortsSamsung Biologics’ CEO and President John Rim held a press conference to share the company’s growth plans and strategies, as well as industry developments. The company’s senior executives also actively engaged with visitors and reporters.John Rim, CEO and President, meets with reporters to share business growth plansBrian Min, Executive Vice President and Head of CDO Center, holds press conferenceJames Choi, Executive Vice President and Head of Sales Support, gives booth tourKevin Sharp, Senior Vice President and Head of Sales, takes part in BPI TheaterThe company also made an impact within the exhibition center and the roads of San Diego, with its vibrant banners and displays.Samsung Biologics’ banners displayed across the exhibition centerOver 140 banners installed on main street leading from San Diego Airport to the exhibition centerSamsung Biologics thanks everyone that connected during BIO 2024 to build new relations and explore partnership opportunities. If you would like to find out more about our agile and flexible services or meet with our experts, please visit our website: www.samsungbiologics.comWe are here to support your program! Related ContentNews Brief Samsung Biologics to attend 2024 BIO International ConventionSamsung BIO Insight Agile. Flexible. Focused on You.

development space. The company recently rebranded its CDO services to highlight the key service elements that the company has to offer with its new slogan – ‘Agile. Flexible. Focused on You.’ Samsung Biologics will also be meeting with existing and potential clients throughout the event to discuss how the company can support them to achieve development and manufacturing milestones.

development, minimizes costs, and prevents delays down the line.”Facility Fit and Gap AnalysisRisk AssessmentAnalytical Tech TransferVerification / Validation RunProcess Development/ OptimizationProcess CharacterizationProcess Performance QualificationStrategic communication is paramount for successEffective communication lies at the core of every successful tech transfer. Samsung Biologics’ dedicated team, comprising technical transfer scientists and project managers, as well as experts in quality assurance and regulatory compliance, maintains constant and transparent communication with clients. Regular meetings and thorough follow-ups ensure collaboration and information sharing, covering all technical aspects necessary for a seamless transfer."Closing the communication gap is crucial for mitigating potential risks throughout the process. By fostering open communication, we ensure our clients are well-informed at every stage. Collaborating closely, we address risks together, ensuring a seamless transfer," Cho highlighted. To enhance the effectiveness, Samsung Biologics has embraced digitalization with the adoption of an Electronic Manufacturing Batch Record (eMBR) system. This system automatically captures data and monitors batch production in real-time, reducing errors and increasing accuracy in the manufacturing process. Additionally, Samsung Biologics provides a uniquely developed “BioProcess Library (BPL)” for clients, helping standardize process parameters and data into a unified document. Looking ahead, we aim to further streamline processes, prevent discrepancies, and enhance data integrity by integrating all related documents into the BPL system.4F Future Space3F 분석, 개발, 기술 이전2F 세포독성약물 접합1F 원자재 수급A CDMO with integrated capabilitiesBy enhancing workflows with process optimization and digitalization of GMP documents, Samsung Biologics has achieved tech transfer timelines as short as three months, half the industry average of six months, allowing us to ensure on-time delivery.“Our track record of success and collaborative efforts with global pharmaceutical companies underscore our dedication to innovation and continuous improvement. We proactively respond to market demand to deliver high-quality products on time despite a shifting regulatory landscape,” Cho added. Through continued expansion into new modalities and manufacturing capacity, Samsung Biologics remains steadfast in its mission to achieve a better life for humanity. With unwavering commitment to excellence, Samsung Biologics stands as your trusted partner in swiftly and efficiently bringing life-changing drugs to market. If you want to learn more about our tech transfer capabilities, read our whitepaper below.Innovative solutions for bioprocessing challenges: How MSAT drives efficient tech transferExplore how we seamlessly execute tech transfers and scale-up processes, leveraging our robust MSAT expertise and advanced technologies, to ensure the success and quality of final productsRelated Contents Whitepapers Streamlining single-use assemblies in the bulk-fill step of downstream processingSamsung BIO Insight Scaling Up Quality and Flexibility with Trusted Partnership

development, agility and flexibility are key service elements that a growing number of drug developers look for when partnering with a CDMO. In this article, we explore what value Samsung Biologics’ development capabilities can offer and how solutions are tailored to meet the specific needs of clients. “Our CDO clients are the innovators who develop treatments that are currently not available. We are committed to supporting those innovators by taking their molecule through the development journey successfully from the beginning. We care about and consider the business achievement they want when working with us.” - Jahoon Kang, Vice President of CDO Development“Samsung Biologics has the ability to react quickly in a planned, risk-based way, enabling the delivery of new medicines with the most efficient timelines, irrespective of the challenges faced during development. The company is also flexible in that it adapts and changes strategies based on what is best for the molecule to overcome unplanned obstacles and maximize the probability of success.”- Daniel Buckley, Senior Director & Head of Ab Cell Purification DevelopmentSamsung Biologics is committed to helping pharma and biotech companies achieve development milestones – ensuring that a program runs smoothly and timelines are met. Building on scientific and regulatory expertise, dedicated teamwork, and thorough planning, the company continues to adapt to innovation and utilizes advanced technology to assess risks and manage challenges without compromising quality.Standard Timeline* (Months)1Cell Line Development2Cell Line Development3Process Development4Process Development5Process Development6Process DevelopmentNon-GMP DS/DP7Process DevelopmentNon-GMP DS/DPAnalytical Tech TransferCGMP DSDocumentation for IND Filing8Non-GMP DS/DPAnalytical Tech TransferCGMP DSDocumentation for IND Filing9Analytical Tech TransferCGMP DSDocumentation for IND Filing10CGMP DPDocumentation for IND Filing10-Month Journey from CLD to IND FilingSamsung Biologics offers a 10-month timeline from cell line development to Investigational New Drug (IND) filing for antibodies and 12 months for complex. The company has launched proprietary technology platforms that can assess molecules and increase ex-pression as well as enhance quality and accelerate timelines.Our Proprietary PlatformsDEVELOPICK™DevelopabilityAssessment PlatformAccurate screening and scoring system to select the optimal candidate within only one month for new drug developmentS-DUAL™Bispecific AntibodyPlatformAdvanced bispecific antibody platform with an asymmetric structure allowing high yield and manufacturabilityS-CHOice®Proprietary Cell LineHigh performing CHO-K1-based cell line development platform with titers up to 7g/LS-CHOsient™Transient ExpressionPlatformA transient expression platform using S-CHOice® for higher productivi- ty and qualityS-Glyn™Modular GlycosylationPlatformA platform to optimize glycosylation regarding ADCC/ CDC functions through the DOE investigation. “For every single project, our experts and scientists from each field come together to understand the unique characteristics of a client’s molecule. Based on our past development experience and after an in-depth analysis, we draw up a personalized solution depending on the client’s needs. During development, seamless communication and collaboration across teams has enabled us to promptly respond when any issue arises.” - Suhil Chung, Senior Manager in CDO SupportSamsung Biologics also offers customized development services – SelecTailor ™ – whereby clients can choose from three packages that best fits their specific goals. Each package is designed to ensure maximum flexibility as clients can fine-tune their own programs by adding service options.Utilizing pre-built modules, the company implements a highly streamlined approach, while assessing potential risks. This framework gives clients a guideline of where to start and what to expect – spe

development and manufacturing organization (CDMO), today announced financial results for the first quarter of fiscal year 2024. “Our continued growth momentum reflects not only our ability to meet the diverse and expanding needs of our clients, but also our unwavering commitment to quality and operational excellence. With accumulated orders exceeding USD 12.5 billion, the demand for our client-centric services remains robust,” said John Rim, CEO and President of Samsung Biologics. “Proactive investments in cutting-edge therapeutic technologies and the ongoing construction of our antibody-drug conjugate (ADC) facility will drive our advancements in next-generation drug development. We also remain fully committed to expanding our production capabilities and securing additional capacity with the completion of Plant 5 next year to support market demands and deliver exceptional value to our partners and shareholders.” FIRST QUARTER 2024 RESULTS In the first quarter of 2024, Samsung Biologics reported a consolidated revenue of KRW 946.9 billion, marking a 31.3% increase from KRW 720.9 billion in the prior-year period. This growth was driven by the successful ramp-up of Plant 4 operations supporting a robust sales backlog and contribution from the Bioepis subsidiary.Consolidated operating profit reached KRW 221.3 billion, while net profit stood at KRW 179.4 billion, marking a 26.5% increase from KRW 141.8 billion in the first quarter of the previous year. The outlook remains positive, with a gradual increase in Plant 4's operations expected to drive quarterly growth and a projected 10-15% annual revenue increase for 2024.On a standalone basis, Samsung Biologics reported KRW 669.5 billion in revenue,13.3% higher than the prior-year period, while operating profit reached KRW 232.7 billion. [Consolidated Earnings, KRW billion] Q1’24Q1’23YoY ChangeRevenue946.9720.9+226.0(+31.3%)Operating Profit221.3191.729.6(+15.4%)EBITDA364.7292.472.3(+24.7%) FISCAL YEAR 2024 OUTLOOK Samsung Biologics remains committed to its strategic investments, poised to meet rising capacity demand and adapt to evolving market dynamics. Construction of Plant 5 is well on track, with operations set to commence in April 2025.To drive future, long-term growth, the company's standalone ADC manufacturing facility, which will be operational within 2024, will enable clients to manage products with maximum efficiency and minimum risk, ensuring high-quality delivery and speed-to-market. In February, Samsung Biologics entered into a partnership with LigaChem Biosciences to collaborate on the development of a solid tumor ADC program. The company has also invested in biotech companies with promising ADC technologies as part of its continued efforts to diversify its portfolio.In line with its net-zero goals, Samsung Biologics continues to embed sustainability into all business operations by improving energy efficiency, transitioning to renewable energy, minimizing the use of disposables, and collaborating with suppliers to reduce their direct emissions. The company was recognized in the first quarter from major ESG agencies, receiving EcoVadis’ Platinum Sustainability Rating and Leadership status with an A- rating from the Carbon Disclosure Project (CDP) for its ongoing efforts to mitigate the risks of climate change. By engaging with global initiatives including the Sustainable Markets Initiative (SMI) and the Sustainable Aviation Buyers Alliance (SABA), Samsung Biologics continues to forge partnerships and drive innovations that accelerate the transition to a more sustainable and low-carbon future.Samsung Biologics recently received the 2024 CDMO Leadership Award in all six performance categories—quality, reliability, capabilities, expertise, compatibility, and services—for its unwavering commitment to client satisfaction.For more details on performance and financials, please refer to the Earnings Release. About

development proficiency is crucial. In this whitepaper, Songyoung Kim, Principal Scientist in Downstream Process Development, discusses how our accumulated experience in downstream enables rapid and reliable product development tailored to meet each project’s needs.

development timelines by optimizing tech transfer processes and refining raw material management protocols in downstream processing. Watch our recent webinar on downstream strategies and gain insights on how we accelerate your program toward success.

development of a drug product with high stability and efficacy. If you haven’t already, watch our on-demand webinar on formulation development strategies and discover how we tackle challenges and tailor solutions for our clients' unique needs.

development service Our All-in-One CDO Service Guide Are you looking for a reliable partner who can help you develop your molecule to IND and beyond? Samsung Biologics offers tailored solutions to best guide your development journey. Learn more about our CDO services from these frequently asked questions. Q1 Can you give a brief overview of your CDO portfolio? We have been developing various types of molecules, from mAbs to complex molecules. We've accumulated approvals from global regulatory agencies. Monoclonal antibody 60% Bispecific antibody 20% Fusion protein 14% Other 6% A CDO projects by molecule types ("From 2018 to 2023) FDA(US) 60% MFDS(Korea) 31% Other(EU, Australia) 9% A IND approval status ("As of Feb 2024) Q2 What is Samsung Biologics' standard development timeline? 10 Months For mAbs, it's 10 months from cell line development to IND filing, and for complex molecules, it's 13 months. Cell Line Development 3 Month Process Development 3~7 Month Non-GMP DS/DP 6 ~ 8.5 Month Analytical Tech Transfer 7 ~ 9 Month CGMP DS 7.5 ~ 9 Month CGMP DP 9.5 ~ 10 Month Documentation for IND Filing 7 ~ 10 Month Q3 Can you provide a developability assessment for my molecule? DEVELOPICK™ is our rapid and agile assessment tool that scores drug candidates based on developability criteria to save you time and cost in the late discovery/early development stage. You can also secure quality material provision through our proprietary transient ex-pression platform S-CHOsient™. 1 Month Primary Structure Assessment Solubility Basic Characteristic Analysis Heat Stress Treatment Low & High pH Treatment Hydrophobic Interaction Analysis Data Reporting Developability assessment process using DEVELOPICK™ Q4 What platforms do you offer throughout the project? DEVELOPICK™ A developability assessment platform utilizing an in-house scoring system S-DUAL™ An asymmetric BsAb platform allowing high yield & manufacturability with maximizing HC-LC pairing S-CHOsice High-performing CHO-K1-based cell line development platform S-CHOsient™ A transient ex-pression platform using S-CHOice" with high-yield productivity and quality S-Glyn™ A glycan profile modulation platform providing an in-depth investigation into the CQAs and cell culture conditions Q5 What kind of flexibility do you offer? Simplified IND Package / accelerated timeline Comprehensive IND Package / Multifaceted Approach Enhanced CMC Package / Productivity Improvement Our Customized CMC Solutions are tailored to your specific development characteristics and stage. Flexible service options for each development process: Cell line development: CHOZN® and S-CHOice® USP/DSP: Diverse media and resin options Analytics: Optimization of development process with additional analyses per client's request Q6 Can you provide a seamless transition from clinical to commercialization? Total Capacity 784KL *Includes Plant 5, which will be operational in April 2025 We offer a fully integrated CDMO service, supported by the world's largest biomanufacturing capacity at a single site Comprehensive in-house analytical capabilities Flexible

development services with customizable CMC solutions incorporating its proprietary platforms to accommodate clients’ evolving needs while ensuring quality. The CDMO Leadership Awards, now in its 13th year, offers accurate and reliable customer feedback to provide support in choosing a reputable partner for development and manufacturing needs. Samsung Biologics has won the award for 11 consecutive years. “Drug and therapy sponsors had much to be concerned with the last 12 months or so. There was still supply-chain uncertainty, ever-growing novelty in platforms and processes requiring new skillsets and technologies, and the speed of everything seemed to accelerate,” said Louis Garguilo, Chief Editor and Conference Chair of Outsourced Pharma. “Through it all, CDMOs stayed focused, and also adapted to customer and market needs. CDMOs may not have had all the answers in an uncertain year, but these are the external partners who provided the biopharma industry with the best solutions.”

development. Watch this webinar to discover how Samsung Biologics’ rapid developability assessment platform, DEVELOPICK™, systematically screens molecules to identify candidates with the best potential for IND and BLA progression.

development and, in turn, saving lives. Read More

development and manufacturing organizations (CDMOs), and raw material suppliers. The role of CDMOs in facilitating this collaboration is critical. Read More

development. Moreover, the company encourages us to diversify our expertise through selective job rotations. Personally, I transitioned from Quality Control (QC) to a business-related department, and later returned to QC. This opportunity allowed me to broaden my skillset and gain valuable experience across different functions. Yongah KimAt Samsung Biologics, we are fostering inclusion not only in regards to gender, but also in how we support employees from different cultural backgrounds. Recently, two expats joined our team and we made it a priority to broaden our communication methods to ensure that they felt included and supported. It's evident that without a culture of inclusion at the department level, individuals, regardless of their expertise, may struggle to fully showcase their capabilities. How can you inspire inclusion? Yongah KimAs a junior scientist, I believe that the diverse perspectives shared by my female colleagues and leaders enrich my understanding and ultimately contribute to a more innovative work environment. Inclusion not only enhances our work, but also promotes a happier workplace for all. By respecting others, and myself, I aim to uncover new possibilities and foster a culture of collaboration and growth. Miyoung ParkAs a mentor, colleague, and leader, my aspiration is to inspire others to share their ideas at any time. Embracing each individual’s unique qualities, I’m committed to fostering an environment of open-minded dialogue. This mindset truly serves as the catalyst for exploring small possibilities, essential for fostering innovation and progress. Through this transparent communication, I try to cultivate a workplace culture where every female voice is heard and respected, thereby propelling us towards collective success and advancement. Related ContentLife @ Samsung Biologics Driven. For Equity. | Embrace equity for a better tomorrowLife @ Samsung Biologics 2022 International Women’s Day | Breaking The Bias

development and manufacturing due to their complex structure. Samsung Biologics' S-DUAL™ platform tackles these hurdles by enhancing productivity and quality through innovative design. In this whitepaper, we explore how an upstream process optimization initiative led to increased productivity and improved commercialization readiness of bsAb programs, resulting in reduced development timeline and cost.

development organization (CDO) service has focused traditionally on cell line, process, analytical, and formulation development. Samsung Biologics has expanded its scope to support late drug discovery and increase success in early development using the S-CHOsient transient ex-pression system and DEVELOPICK platform, as presented by Derrick Katayama (lead scientist of formulation development at Samsung Biologics). Read More

development and manufacturing organization (CDMO), today announced that it has received the Leadership status and A- rating from the Carbon Disclosure Project (CDP).The leadership rating is a recognition of the company’s ongoing efforts to mitigate the risks of climate change and implementation of the current best practices. The CDP, a non-profit organization that annually evaluates corporate environmental transparency, disclosed over 23,000 companies worldwide across 17 categories, including governance, risk management processes, business strategy and opportunity disclosure. Samsung Biologics was granted Management status and B rating in 2022.“The leadership status reflects our progress in sustainability management and collaborative efforts to decarbonize across the supply chain,” said John Rim, CEO and President of Samsung Biologics. “We will continue our environmental stewardship as we implement better services and practices along with our clients and suppliers to mitigate climate risks and build a healthier future.”Samsung Biologics has been bolstering sustainable operations and accelerating the transition to renewable energy by utilizing low-carbon technologies, such as ultra-low NOx burners, solar panels, and energy monitoring systems. The company is also an active member of the Sustainable Markets Initiative and supports various global initiatives, including the United Nations Global Compact and RE100. Last month, Samsung Biologics received the Platinum Sustainability Rating from EcoVadis, the highest rank given, for its sustainability performance.

development, establishing a robust glycosylation control strategy is critical to ensure success. In this whitepaper, we discuss how the implementation of high-throughput lectin assay can lower immunogenicity and optimize pharmacokinetics and pharmacodynamics for recombinant therapeutics.

development and manufacturing organization (CDMO), today announced it has signed a partnership agreement with LegoChem Biosciences (KOSDAQ: 141080), a biotech company pioneering the research and development of antibody-drug conjugate (ADC) programs.​ Under the terms of the deal, Samsung Biologics will provide antibody development and drug substance manufacturing services as a part of LegoChem Biosciences’ ADC program designed to treat solid tumors. LegoChem Biosciences aims to submit an Investigational New Drug application to the U.S. FDA in the first half of 2025, with non-clinical data showing promising efficacy results. The company is also on track to adding ADC to its pipeline, with the construction of a standalone, dedicated ADC facility expected to be operational within 2024. “Collaboration between Samsung Biologics and LegoChem Biosciences will enable us to deliver on our common goal to develop and manufacture efficient and safe therapeutics for patients,” said John Rim, CEO and President of Samsung Biologics. “We look forward to working with LegoChem Biosciences to support their pipeline of innovative ADC candidates and secure new opportunities in the fast-growing ADC field.” “LegoChem Biosciences had previously supplied antibodies for ADC through only overseas companies, but we expect that we will be able to secure a stable domestic supply chain through this contract,” said Yong-Zu Kim, CEO and President of LegoChem Biosciences. Samsung Biologics will offer comprehensive services for ADC development and manufacturing, building on its expertise and capacity in antibody engineering, process development, and large-scale manufacturing of antibodies. The company has also been making active investments through the Samsung Life Science Fund in biotech companies pioneering ADC linker technologies and toolbox.

development and manufacturing organization (CDMO) has helped its clients stay current in order to seize a future edge in the market. “The biopharmaceutical market is one of the fastest evolving industries where timely adaptation to dynamic market needs is critical for both business excellence and sustainability,” said Jay Kim, a Senior Market Analyst at Samsung Biologics. “The challenge is finding a way to secure enough resources and ute intricate development/manufacturing processes with the utmost quality within a condensed timeline. And this is where CDMOs can offer a hand.” The global CDMO market has steadily increased in size in recent years, suggesting the biopharmaceutical industry has become more reliant on partnerships with CDMOs. Narrowing down the scope, Kim said the industry’s burgeoning need for contract services may in part be attributed to a CDMO’s end-to-end capability in advancing a raw molecule, either monoclonal or complex, to a drug product ready for commercialization. “A growing spotlight on therapeutics of complex molecules, such as antibody-drug conjugate (ADC) and bispecific antibody (BsAb), may indicate that the industry would ask for an end-to-end CDMO service more in the future than it used to before,” said Kim. Samsung Biologics has been an industry forerunner helping global drug makers and developers secure a business edge in the competitive market, both present and future. 15KL X 46 690KL10KL X 6 60KLCombined Total 784KL Bio Campus / 604KL + plant 5 180KL1KL X 2(single-use), 1KL X 2(stainless steel) 4KL5KL X 6 30KLP5 to be Operational in April 2025The global CDMO in 2023 completed the world's single largest manufacturing facility, Plant 4, and broke ground on building an additional four plants with the first one (Plant 5) expected to be CGMP ready by April 2025. “The way Samsung 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 for us to continue to work together,” said a U.S. biotech Executive, whose company is in a drug-development partnership with Samsung Biologics. To prepare for a future increase in the industry’s need for robust one-stop services, Samsung Biologics in 2023 strategically invested to reinforce its drug-development platforms, such as S-CHOsient™ and S-Glyn™, to help maximize the viability of a delicate drug development project, especially one involved with complex molecules, of its clients by developing a high-titer cell line. “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,” said an Executive of another U.S. biotech, which Samsung Biologics helped develop a cell line with a nearly tenfold amount of titer than the previous. “Samsung’s experience going from cell line development to commercialization has been one of the best things about our partnership.” Samsung Biologics’ preemptive investments to keep up with what drives the industry will continue in 2024. The client-centric CDMO is planning to finish the construction of its ADC facility within 2024 so that it can offer flexible ADC development services. “Every development made at Samsung Biologics is for clients and for patients,” said Kim. “And it is never a coincidence that our business decisions are well aligned with serving the industry’s immediate and future needs.” Related Contents Samsung BIO Insight Samsung Biologics 2023 | Year in Review Samsung BIO Insight Scaling Up Quality and Flexibility with Trusted Partnership

development, and quality management fundamentals were the hot topics of discussion at CPhI Barcelona 2023. These topics are the framework for what we anticipate seeing more of in 2024. Drug Development & Delivery asked some of today’s life science leaders what they expect will have the greatest impact on drug development this year and beyond. So, back by popular demand, below is the third annual exclusive Leadership Panel discussion.Read more

development and manufacturing is a rapidly growing sector requiring ample investment and attention to meet rising demands. Advancements in technology, growing understanding, and strategic approaches have shifted the biopharmaceutical industry to better position itself to meet growing demands with innovative thinking.Drug Development & Delivery recently interviewed Kevin Sharp, Senior Vice President and Head of Sales for Samsung Biologics, to discuss the evolving biopharma space, exploring current challenges, and the demand for sustainable solutions. Read more

development and manufacturing organization (CDMO), announced robust financial results for the fourth quarter and fiscal year 2023. "We have achieved another remarkable milestone with our consolidated operating profit surpassing KRW 1 trillion in the 12 years since our founding in 2011. Our unwavering commitment to customer-centric services and continuous innovation remains at the core of our mission, ensuring the delivery of high-quality biomedicines to patients worldwide,” said John Rim, CEO and President of Samsung Biologics. “Despite the challenging environment, we remain optimistic, anticipating continued growth driven by sustained partnerships, expanded capacity, and strategic portfolio diversification in the coming year." FOURTH QUARTER & FISCAL YEAR 2023 RESULTS In the fourth quarter of 2023, consolidated revenue recorded KRW 1.07 trillion, marking an 11.2% growth from KRW 965.5 billion in the same period from the previous year. This exceptional performance is attributed to the successful ramp-up of Plant 4 operation and a robust sales backlog. In 2023, Samsung Biologics accumulated contracts worth over USD 12 billion by expanding its partnerships with 14 of the top 20 global pharmaceutical companies. For the full-year 2023, the company posted a record-high consolidated operating profit of KRW 1.11 trillion, up by 13.2% from KRW 983.6 billion in 2022. Consolidated revenue reached KRW 3.69 trillion, reflecting a 23.1% increase from the previous year. The outlook remains strong, with resilient business performance expected to drive a 10-15% annual growth in revenue for 2024.[Consolidated Earnings, KRW billion] Q4’23 Q4’22 YoY change FY23 FY22 YoY change Revenues 1,073.5 965.5 +108.0 (+11.2%) 3,694.6 3,001.3 +693.3 (+23.1%) Operating Profit 350.0 312.8 37.2 (+11.9%) 1,113.7 983.6 +130.1 (+13.2%) EBITDA 491.9 405.2 +86.7 (+21.4%) 1,603.5 1,291.9 311.6 (+24.1%) On a standalone basis, Samsung Biologics recorded a revenue of KRW 2.94 trillion and operating profit of KRW 1.2 trillion in 2023. In the fourth quarter of 2023 alone, the company posted a revenue of KRW 827.9 billion and operating profit of KRW 334.0 billion. FISCAL YEAR 2024 OUTLOOK Building on this momentum, Samsung Biologics plans to continue making strategic investments in expanding capacity and global reach, while enhancing capabilities to better meet clients' evolving needs. With Plant 4's full operation, commenced in 2023 as previously committed, the increased production capacity is expected to gradually enhance its contribution to future revenue. Having successfully completed engineering run and Process Performance Qualification (PPQ), and obtained regulatory approval for large-scale production, Plant 4 is projected to contribute approximately 30% of drug substance manufacturing business revenue by 2025. Plant 5, the first facility of the company’s second Bio Campus, is set to begin operations in April 2025, five months ahead of its initial construction timeline. To accommodate each client’s ever-evolving needs, Samsung Biologics introduced customized CMC solutions: three development packages designed to ensure maximum flexibility and meet clients’ goals per their development stage. The company’s newly launched development platforms, S-CHOsient™ and S-Gl

development and manufacturing organization (CDMO), today announced that the company was awarded the EcoVadis’ Platinum Sustainability Rating, the highest recognition given, for the company’s sustainability management. The Platinum Rating places Samsung Biologics in the top one percent of the over 100,000 companies assessed by EcoVadis, a global evaluation platform that assesses the corporate social responsibility performances of companies in four main areas: Environment, Labor & Human Rights, Ethics, and Sustainable Procurement. Samsung Biologics received the Gold Sustainability Rating in 2022. "The Platinum Rating underscores our sustainability leadership and reflects our unwavering commitment to decarbonization, ethics, and responsible business practices," said John Rim, CEO and President of Samsung Biologics. "We understand that sustainability is increasingly important to all our customers and this latest accreditation reaffirms our mission in creating a healthier future for society through better services and business practices." Samsung Biologics has been publishing annual Environmental, Social, and Governance reports, outlining its green strategies towards decarbonization and efforts to engage suppliers to minimize potential social and ethical risks. The company is committed to achieving zero greenhouse gas emissions and 100% renewable energy across its sites and supply chains by 2050. Samsung Biologics is also a member of the Sustainable Markets Initiative (SMI) and was the first CDMO to receive the SMI’s Terra Carta Seal, in recognition of the company’s efforts to drive innovation and demonstrate commitment to the creation of sustainable markets. Samsung Biologics has also joined global initiatives, including the Sustainable Aviation Buyers Alliance and the United Nations Global Compact. For more details and updates on our sustainability efforts, please visit here

development project from the beginning. In a continuous effort to help de-risk and maximize the project's commerciality, Samsung Biologics has enhanced its early drug-development platforms, a foundation for one-stop drug manufacturing. Read how a globally leading contract development and manufacturing organization (CDMO) is prepared to advance its clients’ molecules to the Investigational New Drug stage and beyond with maximized quality and minimized risk. Unleashing the Full Potential of a Molecule Whether to successfully advance a molecule from late discovery to commercialization depends on how many risks can be identified and addressed at an assessment stage. Risks may stem from not having fully implemented a molecule’s characterization and failing to sort out low-potential drug candidates, Samsung Biologics has recently launched a late drug-discovery platform, S-CHOsient™, to phase out such risks. By transiently expressing high-quality genes at different scales, S-CHOsient™ increases the reliability and performance of the developability assessment platform, DEVELOPICK™. Testing across various modalities, from monoclonal antibodies to Fc-fusion proteins, has yielded a higher titer under a condensed timeline when compared to results from other industry platforms. Quality comparisons, based on percent purity analysis, demonstrate compatibility, enabling a wide range of options for our clients' development needs. “We wanted to add S-CHOsient™ to our development platform portfolio to help build a reliable foundation for successful drug development for our clients,” said Lee, Director of Cell Line Development at Samsung Biologics. “By assessing a thorough molecule characterization and expressing robust genes, the platform prepares our clients to unleash the full potential of their molecules.” Navigating the intricate pathway to biopharmaceutical commercialization also demands careful selection of the right sequence or molecule for development. Samsung addresses this challenge through DEVELOPICK™, a tool that assesses the physical-chemical properties of molecules, providing crucial insights into purification processes and setting the stage for efficient cell line development (CLD). Developing strong cell lines through an enhanced CLD platform Samsung Biologics’ CLD platform is rigorously designed to generate robust cell lines. S-CHOice®, a high-performing proprietary cell line platform built on glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line technology, shows improved titers up to two-fold from industry average, reaching above 7g/L for standard monoclonal antibodies. The cell line also shows enhanced cell viability with over 90% at day-21 in a fed-batch study, demonstrating effectiveness in producing high-quality cell lines. With both standard and transposase processes, the platform has successfully developed over 60% of monoclonal and 20% of bispecific antibodies. The recent introduction of a transposase gene integration system further enhances titers. With the capability for multiple insertions across the genome and applicability to genes of all sizes, while maintaining structural integrity, the transposase system has resulted in notable increases in productivity, purity, and stability. S-CHOice® generated a 3 to 7-fold increase in cell-line productivity and a significant 33% reduction in the standard timeline for monoclonal antibodies, leading to a two-month period from transfection to Research Cell Bank (RCB)* selection. Additionally, bispecific antibodies experienced a 25% reduction, allowing for a three-

development and manufacturing organization (CDMO), today presented its 2024 business plans and strategy at the J.P. Morgan Healthcare Conference held in San Francisco, California. During the main track presentation, John Rim, CEO and President of Samsung Biologics, announced that the company will continue to add fresh capacity and further diversify its portfolio in the new year to deliver on its commitment to produce high-quality biomedicines and ensure client satisfaction despite a challenging environment. “This year, we expect to face fiercer competition and challenges as we prepare for the next decade of growth,” said Rim. “We will continue to make bold investments in capacity and geographic expansion to address the growing market demand, while securing core capabilities in new modalities to better serve and meet the evolving needs of our clients.” Samsung Biologics broke ground on its second Bio Campus last year and has been accelerating the construction of Plant 5, which will bring up the company’s total biomanufacturing capacity to 784,000 liters upon its completion in April 2025. By 2032, Bio Campus II will house four plants, each with a capacity of 180,000 liters, and combined with Bio Campus I, will enable Samsung Biologics to provide over 1.3 million liters’ capacity to clients worldwide. The company is also building an antibody-drug conjugate (ADC) facility at a separate site, with the aim to commence operations by 2024. The company has been investing in biotech companies with advanced technologies to secure relevant ADC capabilities. Samsung Biologics also plans to expand its partnerships with both global pharma and emerging biotech companies by offering services incorporating its newly launched CDO platforms, S-CHOsientTM and S-GlynTM, that ensure higher productivity and quality of a molecule for successful drug development. In terms of geographical expansion, Samsung Biologics will continue to conduct inorganic expansion studies to identify new sites to work in closer proximity to its clients, in addition to its sales offices in New Jersey and Boston, in the U.S. “Our utmost priority will be providing the highest level of customer-centric services by improving all areas of our business through innovation and technology to bring sustainable value to all of our clients and partners,” added Rim. “We will continue to build on our strong foundation of trust and pursue our mission to deliver high-quality biomedicines to as many patients around the world.”

development services incorporating innovative processes and advanced proprietary platforms to accommodate clients’ evolving needs – supporting their journey from gene to investigational new drug and/or beyond. The company 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, while assessing potential risks. Related News Customized CMC Solutions: The best fit for your development strategy Enhancing quality by employing cell line replacement and process optimization Forging a trusted partnership in end-to-end drug development Building a transformative partnership in drug development Industry Trend-Setter Samsung Biologics attended a series of global conferences and exhibitions this year, including BIO International, CPHI, DCAT, and J.P. Morgan Healthcare Conference. The company demonstrated how its services can accelerate clients’ drug journey and maximize the potential of their molecule. Samsung Biologics also consolidated its presence as a sustainable partner with an eco-friendly booth. The company also actively used the events to engage with existing and potential clients for future development and manufacturing pacts. Related News Samsung Biologics Amplifies “Sustainable Partnership” | Highlights from 2023 BIO International Convention Samsung Biologics continues to expand for sustainable future | Highlights from J.P. Morgan Healthcare Conference 2023 Prioritizing Sustainable Leadership Samsung Biologics was awarded the Sustainable Markets Initiative’s Terra Carta Seal, becoming the first CDMO and the first Korean company to receive the Seal. The Terra Carta Seal, launched at the COP26, recognizes global companies that are driving innovation and demonstrating their commitment to, and momentum towards, the creation of genuinely sustainable markets. It is awarded to companies whose ambitions are aligned with those of the Terra Carta, a recovery plan for Nature, People and Planet. Related News Samsung Biologics receives the Terra Carta Seal in recognition of the company’s commitment to creating a sustainable future Global healthcare leaders advance sector decarbonisation ahead of COP28 Advancing Global Decarbonization Targets Samsung Biologics believes the road to a net-zero supply chain starts from a grassroots engagement with its domestic partners. Samsung Biologics held its inaugural Supplier ESG Day at its headquarters to share ESG knowledge and guidance on decarbonization with its local suppliers. At the event, experts provided insights on ESG governance, while representatives from global suppliers presented case studies and tangible methods that local suppliers could apply to their operations. Related News Samsung Biologics engages suppliers to advance global decarbonization targets Shaping a sustainable supply network for net-zero health systems Open letter on supplier targets from members of the Sustainable Markets Initiative Increased Global Recognition At the CDMO Leadership Awards 2023, Samsung Biologics received the Champion Award in four categories – capabilities, compatibility, reliability, and quality - and the Excellence Award in all six categories. Samsung Biologics has won the awards for ten consecutive years. The award offers accurate customer feedback to provide support in choosing a reputable partner for development and manufacturing. Samsung Biologics was also recognized by Newsweek as one of the ‘World’s Most Trustworthy Companies’ for 2023. Related News Samsung Biologics recognized for business excellence in receiving the 2023 CDMO Leadership Awards for 10th consecutive year Samsung Biologics recognized by Newsweek as one of the 'World's Most Trustworthy Companies for 2023'

development platform has been newly brought up to drug developers wanting to create an optimal set-up for successful manufacturing of their hard-developed drugs. At the forefront of this transformation are antibody-based therapeutics, such as bispecific antibodies (BsAbs). The introduction of novel, intricate antibody-based therapeutics into the drug pipeline presents opportunities to effectively treat more patients. However, the advancement of novel biologics also introduced development and manufacturing difficulties that emphasize the need for flexible solutions with the ability to overcome complexity. In this article, Jiseon Oh, Lead Scientist in Formulation Development at Samsung Biologics, discusses the role of contract development organization (CDO) partnerships in successfully progressing complex biologics from clinic to commercialization. She underscores the importance of integrating innovative technologies early in the process and using proprietary development platforms to overcome challenges without compromising quality or delaying timelines.​Read more

Development So my philosophy in life is to always grow and improve day by day, both for myself and also for the people around me. In every job, I always look back and reflect on the legacy I leave behind and if I’ve left the environment better than I found it. With Samsung Biologics, I'm on this journey, where I come to work every day knowing that I am making a difference. We're constantly improving our technology to enhance the robustness of our processes, to improve the quality of our products, and to bring medicines to more people across the globe. To hear more stories and reflections from our employees, please watch our full “What is Life?” video below.

development journey.

Development highlights how our proprietary platform, S-Glyn™ evaluates N-glycan profiles and optimizes effector functions by leveraging the DoE approach, resulting in streamlined development timelines.

development and manufacturing processes. Product-specific chemistry, manufacturing and controls (CMC) platforms are required at all stages throughout the development of biologics. By partnering with external organizations that offer integrated CMC solutions, biopharma companies can ensure the successful development and manufacturing of complex biologics and deliver therapies to patients sooner. In this article, Jiwoo Bae, Senior Scientist in Complex Antibody Downstream Process at Samsung Biologics, explores how integrated CMC solutions can bring success to the development and manufacturing of complex biologics. She shares unique insights into the evolution of biologics, the rising demand for more complex therapies and hitting key development milestones, with information on how integrated CMC platforms can bring these areas together and deliver successful biologics development and manufacturing. ​ Read more

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

development and 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.

development. In this webinar, Derrick Katayama, Lead Scientist in Formulation Development, shares how our proprietary platforms, DEVELOPICK™ and S-CHOsient™, can help streamline processes to reduce development time and cost.

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.

development environment, small to mid-sized biotechs may want to work with external partners to increase the chance of bringing success to their drug development projects. In this article, Jahoon Kang, Vice-President and Head of CDO Development Department, and Yeukyung Yoon, Associate Director in Analytical CMC Development, at Samsung Biologics probe the role of contract development and manufacturing organisations (CDMOs) in providing versatile process development platforms and customised solutions designed to create an optimised set-up for drug manufacturing. Read more

development and 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 t

development, 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.

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

development process, chemistry, 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.

developments regarding Bio Campus II and promoted its CDO services, including proprietary platforms and new customized CMC solutions for optimized drug development. Samsung Biologics also participated in poster sessions as well as a speaking session where Lee, Director of Cell Line Development, shared her insights on how utilizing the company's S-CHOice® CLD platform can maximize protein efficiency. To learn more about Samsung Biologics' CDO services, visit the CDO page or download the brochure for more information.

development of life-saving medicines for patients with severe neurological diseases, such as brain cancer, Alzheimer’s disease, and Parkinson’s disease. AimedBio has also developed a robust therapeutic pipeline, including a first-in-class ADC experimental drug targeting FGFR3 for brain and bladder cancers, which is expected to enter clinical trials in 2024. In addition to the investment, Samsung Biologics signed a research collaboration agreement to co-develop ADC toolbox technologies and a contract development agreement to support the development of AimedBio’s monoclonal antibody therapy for atopic dermatitis and dementia. These agreements reflect Samsung Biologics’ commitment to exploring and developing innovative technologies for next-generation biomedicines. The Company plans to expand its business portfolio to include ADCs and is currently building its own separate ADC 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.”

development. Having a robust development plan with well-thought-out strategies—one that considers potential risks but commits to speed and quality—right from the beginning is crucial to advancing a drug candidate throughout the entire development path successfully. In this article, we delve into how Samsung Biologics can steer clients through the drug journey and unleash the full potential of their candidates via its customizable CMC* solutions tailored to the development goals of each client. *Chemical, 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 goal While 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 Package The 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 Package The 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 Package The enhanced CMC package focuses on improving productivity. This program facilitates end-to-end provision through the replacement of cell lines, processes, or formulatio

When it comes to the challenges and trends biomanufacturers face, from market disruptions to the innovations in diverse and complex molecules, Samsung Biologics recognizes the evolving need for flexibility and quality in drug 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 Plant130,000L5K x6Plant2154,000L15K x101K x21K x2Plant3180,000L15K x12Plant4240,000L15K x1210K x6Plant5180,000L15K x12Samsung 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

development and 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.

Development Organisation (CDO) Business Strategy at Samsung Biologics, explore the role of competitive CDO partnerships in overcoming the challenges of producing complex biologics at speed. Providing their unique insights, Kim and Lee also emphasise the need to implement innovative technologies in the early stages of drug development and discovery through proprietary development platforms to accelerate timelines without impacting quality. Read more

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 patients brings us hope that one day, our drugs that Samsung is manufacturing for us will save lives.” For a CDMO to carry out an accelerated end-to-end drug development project, it requires technical expertise and experience as well as the capacity that enables the CDMO to readily provide services to its clients when they nee

development and 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 RESULTS Samsung 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 emission

development and 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.

Development, explains why it is essential to choose the right CDMO partner for successful development and how Samsung Biologics supports clients through innovative technologies and best-in-class solutions.

development and 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.

development, the pharma industry is increasingly focused on maximizing the effectiveness of early-stage candidate assessments. In this whitepaper, Derrick Katayama, Lead Scientist in Formulation Development and Heonchang Lim, Head of Formulation Development, provide insights on how Samsung Biologics’ developability assessment platform, DEVELOPICK™ can help mitigate risks by facilitating the identification of potential issues.

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

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

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.”

Development Group, strives to incorporate circular actions in the lab by preventing unnecessary waste and disposing of used plastics properly. She emphasized that the team has incorporated strict GMP procedures to ensure that they’re using resources sustainably without generating excess waste. “Even in our marketing and event materials, we’re constantly looking for ways to replace plastics with sustainable alternatives.” For this year’s BIO International conference, Seoyoon Cheong, a Senior Specialist in the Marketing Group, designed an eco-friendly booth that replaced plastic materials with sustainable alternatives such as wood and cloth. Samsung Biologics Booth at BIO International 2023 QR code at BIO International 2023 Greener Together! Samsung Biologics aspires to lead the industry in protecting our planet for the health of future generations. As part of our mission to build a more sustainable future for all, we are committed to achieving zero greenhouse gas (GHG) emissions and 100% renewable energy across our sites by 2050 or earlier. *United Nations Environment Programme. (2023 May 16). Turning off the Tap: How the world can end plastic pollution and create a circular economy. https://www.unep.org/resources/turning-off-tap-end-plastic-pollution-create-circular-economy Related Contents Sustainability ESG management Press Releases Samsung Biologics receives the Terra Carta Seal in recognition of the company’s commitment to creating a sustainable future

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 using expertise and digital innovation to make a positive impact on the healthcare industry. Related Contents Samsung BIO Insight Samsung Biologics’ Super Plant 4, How the world’s largest biomanufacturing plant will drive clients’ success Webinars EQUIS: A Platform for Digital Transformation at Samsung Biologics

development success Christina Lorentz, left, Director of Clinical Operations at Aronora, and Brandon Markway, right, Director of Chemistry, 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 expertiseBased 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 lineAcquiring 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 Biologics’ project managers invaluable.“The project managers at Samsung Biologic

development (CLD) timelines, product quality, and drug stability continue to impose difficult bottlenecks that disrupt clinical trials, bringing attention to CLD practices and opportunities to achieve faster timelines. In this whitepaper, we discuss how to overcome the challenges in cell line development through early-stage assessment and management. We also share how Samsung Biologics balances quality and titer through the application of high-throughput analytic methods to cut risk, time, and cost.

development and 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] Q1’23Q1’22YoY ChangeRevenue720.9511.3+209.6Operating Profit191.7176.4+15.3Net Profit141.8146.9-5.1EBITDA292.4218.7+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. For more details on performance and financials, please refer to the Earnings Release.

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.”

development and manufacturing needs within the biopharmaceutical and pharmaceutical industry. Since 2013, Samsung Biologics has been recognized in the CDMO Leadership Awards for ten consecutive years.

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.

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.

development program. Read more

development while introducing the new bispecific antibody platform S-DUAL™.

development while advanced technologies have accelerated the development of new modalities. In this PharmTech article, Eonyoung Park, a lead scientist in our mRNA-based research team at Samsung Biologics, shares her insights on combatting future viral threats with vaccine advances.Read more

development and 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.

development.Read more

Development Group, shares her insights on how a streamlined CLD process can fast-track biologics to IND.Read more