SAMSUNG BIOLOGICS

Development- And others Communication Communicate to - Client- Staff- Regulatory Agency- Audit committee- And others BCMO The strategic teamfocuses on strategic issues that impact the organization’s core objectives, products andservices is led by top management. The crisis management team has primary responsibility for addressing any crisis impacting the organization.※ BCMO: Business Continuity Management Office The tactical teamsmanage and coordinate the continuity of the processes required to deliver the impacted products and services, and ensure that the resources are allocated appropriately and is led by team leader. Tactical level plans provide a framework to coordinate strategic goals and decisions with the operational response teams. The operational teamsfocus on the continuity of the activities that contribute to the process or processes that deliver the prioritised products and services and is led by each functional site matter expert. An operational response establishes the necessary capability required to continue to deliver prioritised products and services The strategic teamfocuses on strategic issues that impact the organization’s core objectives, products andservices is led by top management. The crisis management team has primary responsibility for addressing any crisis impacting the organization.※ BCMO: Business Continuity Management Office The tactical teamsmanage and coordinate the continuity of the processes required to deliver the impacted products and services, and ensure that the resources are allocated appropriately and is led by team leader. Tactical level plans provide a framework to coordinate strategic goals and decisions with the operational response teams. The operational teamsfocus on the continuity of the activities that contribute to the process or processes that deliver the prioritised products and services and is led by each functional site matter expert. An operational response establishes the necessary capability required to continue to deliver prioritised products and services Annual Operation Our embedding BCMS is the ongoing cycle of activities of the business continuity management program, that build organizational resilience, and is the professional practice that defines how to integrate business continuity awareness and practice into business as usual activities Embedding BCMS Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Performing Risk and Threat Mitigation Measures Implementation - Implements the solutions agreed in the designed stage · Development of Tactical/Operational Business Continuity Strategy· Establishment of Business Continuity Plans & a response structure Validation - Confirms that the business continuity program meets the objectives set in the policy and the plans and procedures in place are effective. · Exercise Program: performing annual exercises with various types of scenario by each department as well as company-wide· Management Review to ensure it aligns with organizational objectives Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Performing Ri

Development, Quality, Regulatory, Operations and product Commercialization. Mr. Machour served in a variety of positions of increased responsibility and scope and held senior and global leadership roles at Lonza, Becton Dickinson, Pfizer, J&J and Boehringer Ingelheim. Mr. Machour holds a Master’s degree from Concordia University in Physics and is a board member of George Mason University in Songdo. SENIOR VICE PRESIDENT / CFO Dongjoong Kim Dongjoong Kim is Senior Vice President and Managing Director in charge of the Business Resources Innovation Center which includes the Finance Team, Business Innovation Team and Global Employee Satisfaction Team. detail open Prior to joining Samsung Biologics in 2014, Mr. Kim held various corporate planning and managerial leadership positions for Samsung Electronics. Mr. Kim began his career with Samsung in 1988. Mr. Kim led the Corporate Management and Administration of Samsung Electronics from 2002 to 2014. SENIOR VICE PRESIDENT / CBO James Park James Park is Senior Vice President and Managing Director of the Global Business Development Center responsible for BD Operations Team, BD Innovation Team, BD Integration Team, Drug Product and small-scale CMO of Samsung Biologics. detail open Prior to joining Samsung Biologics in 2015, Mr. Park held various technical and operational positions, as well as business development management leadership positions in biopharmaceutical companies in the U.S. Mr. Park began his career in 1989 with ALZA Corporation, a subsidiary of J & J, as a chemical engineer where he participated and led process and product development, technology transfer, validation and commercialization of several OROS products. He then worked in Technical & Alliance Management at Watson Pharmaceuticals. Transitioning to Merck as a Change Agent/Six Sigma Project Manager, Mr. Park then managed the Operational Excellence projects related to process improvements, cost savings and quality initiatives. From 2004 to 2015, Mr. Park participated in and directed 100+ CMC due diligences on assets ranging from pre-clinical to commercial products, and managed Global Manufacturing & Supply BD activities including Licensing, Outsourcing and M&A at Bristol-Myers Squibb. Mr. Park has over 25 years of experience in the biopharmaceutical and pharmaceutical industries. SENIOR VICE PRESIDENT Hoyeol (James) Yoon James Yoon is Senior Vice President and the Managing Director of the CC&C Center responsible for Communication, Procurement and Contract Development Services of Samsung Biologics. detail open Prior to joining Samsung Biologics in 2011, Mr. Yoon held various corporate planning and managerial leadership positions for Samsung Total Petrochemicals, a Joint Venture Company between Total of France and Samsung. Mr. Yoon began his career with Samsung in 1986. Mr. Yoon led the business development and financial restructuring of Samsung General Chemicals from 1997 to 2003. Mr. Yoon managed administration for the Joint Venture, including the negotiation of major license agreement for petrochemicals production plants. SENIOR VICE PRESIDENT / CIMO James Choi James Choi is Senior Vice President and Chief Information & Marketing Officer and head of Investor and Global Public Relations at Samsung Biologics. detail open Prior to joining Samsung Biologics in 2014, Mr. Choi held various technology and operations leadership positions at major global healthcare and informatics corporations. Mr. Choi began his career with Philips Healthcare in 1989 as Site Planning Manager and advanced through leadership positions in Customer Service eBusiness and Technology, Operations, and Information Systems for North America. Mr. Choi then transitioned to the Informatics and Security industry and was CIO for a major background investigations, insurance int

Development, and Research and Development in the US and Europe. Mr. Rim has also held senior leadership roles with Astellas Pharmaceuticals in General Management, Sales & Marketing, Technical Operations, Customer Service, Business Development, and Strategic Planning. Mr. Rim has over 30 years’ experience in the biopharmaceutical industry and began his career as a management consultant with Booz, Allen & Hamilton consulting to pharmaceutical companies in the US and Europe. CEO Message Detail CEO Message For over a decade, Samsung Biologics has rapidly evolved into the world's largest and best-in-class CMO service provider, and now, we are continuously expanding our CDO and CRO business areas to make the next leap in biopharma. In this next decade, we will continue to build greater capabilities to meet new market demand as a top service provider in the biopharmaceutical industry while ensuring quality and stable supply of life-saving drugs. Since its launch, Samsung Biologics has not only expanded its manufacturing capacity but also established a solid track record of successful regulatory approvals and award-winning client satisfaction. In efforts to provide the highest level of customer-centric services, Samsung Biologics has implemented leading edge technologies and with great agility, demonstrated distinguished processes in terms of speed, price competitiveness, quality, and efficiency. We are facing a time of significant challenges and market dynamics. To respond proactively, we are making bold moves by adding Plant 4, with the largest and most flexible manufacturing scales, to our headquarters as well as carrying forward with global expansions with the CDO R&D Center. We expect synergies from collaborations between the new global locations and our manufacturing site in Songdo, a rising bio hub. With a steadfast vision and unrelenting drive to achieve better life for all, we embrace responsibility, expertise, and pride in our work, and will continue on our noble mission to enable improved accessibility of biomedicines and consequently the quality of life for people around the globe. We will challenge ourselves to improve in all facets of our business through innovation, dedication, and teamwork so that we can continue to add meaningful value to all of our clients, partners, and shareholders. Thank you for your continuous trust and support. John Rim President & CEO President & CEO, Samsung Biologics John Rim sign

Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes.Analytical Testing CapabilitiesAcross the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release, and stability.Our QC team is capable of performing analytical test method transfers from client laboratories, method validation, qualification, and verification in accordance to ICH Q2 (R1) guidelines, FDA, EMA, and PMDA requirements.Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of:Chemical Testing1. Impurity / Purity by HPLC2. Identification by FT-IR3. Water content4. Osmolality, Protein Content (A280), Appearance, pHBiochemical Testing1. Polymerase Chain Reaction (PCR)2. Enzyme-Linked Immunosorbent Assay (ELISA)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based AssaysMicrobiological Testing1. Sterility2. Microbial Limit (Bioburden)3. Microbial Identification4. EndotoxinStability Program CapabilitiesWe maintain controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and accelerated conditions (with temperature and/or light).Environmental and Clean Utility MonitoringThrough our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that our controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable air particles and surfaces. Clean Utilities Monitoring includes the testing of water, compress gases, and clean steam for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.

development stage to DS products for lot release tests of Mycoplasma & Virus detection. Our service is expanding to Cell bank manufacturing, Cell line characterization and Viral clearance study. Overview imageSamsung Biologics CRO?Lot Release TestingMycoplasma & Virus detection, Sterility, Endotoxinand Bioburden testingCell Line CharacterizationIdentity (NGS), In vitro / In vivo virus screen,Adventitious, Retrovirus and mycoplasma testingCell Bank ManufacturingMCB / WCB / EOPC manufacturing andcell storage servicesViral ClearanceVirus inactivation and removal study (GLP)

DevelopmentFinishingFully Automated Visual InspectionSecondary Bulk PackagingStorage& Shipping2-8 ℃ to -70 ℃ Storage OptionsPassive and Active Shipping OptionsRegulatorySupportApproved in over 20 Global MarketsType V DMFFull CMC end-to- end support1 / 5Client Satisfaction We are committed to Re-inventing the Client Experience in the DP CMO world. From the first point of contact, we are committed to ensuring you have the most pleasant experience possible. We know Tech Transfers, Clinical Trials and Commercial Operations can be very difficult and daunting; we are here to help you simplify and succeed in your program objectives. We’ll make it easy on you and your team.just the way it should be. Speed to Market We live in an industry where mere days can make the difference between a blockbuster success or a complete program implosion. We are confident that you’ll find our expertise in development, tech transfer and commercialization to be the missing link to achieving your goals. Our entire facility is designed around the intention to get your product to market faster and better. Adaptability We can help. Our facility and systems have been designed to be able to adapt to the many nuances and requirements of our strict industry. Our staff of seasoned experts and well appointed facilities are ready and able to take on nearly every challenge keeping you awake at night. If we don’t have it, we’ll work with you to design the system or purchase the equipment to ensure your success. We are here to serve you and your patients.