DevelopmentAt our state-of-the-art facility, a team of highly skilled scientists and engineers offers full in-house analytical capabilities. We provide end-to-end solutions for a wide range of biotherapeutics, from monoclonal antibodies to more complex modalities. Recognizing the unique challenges posed by non-mAb molecules, we have developed bespoke analytical methods tailored to your specific requirements. With our unwavering commitment to quality and innovation, we are your trusted partner in navigating analytical development, ensuring the success of your biotherapeutic programs.Analytical Method DevelopmentAnalytical Method (Release)Extended Characterizationselected Cell-based AssayDoE Approach to ADCC/CDC ModulationCharacterization & Comparability StudiesStability StudiesNon-GMP Stability TestingIn-use StabilityDe-risking Product DevelopmentSequence Variant Analysis (SVA)Host Cell Protein (HCP) Identification

Development / QC / MSATHPAPI facilityOccupational Exposure Limit (OEL) target of 5ng/m³ Dependable ADC ServiceWe offer comprehensive services that range from antibody production and conjugation development to manufacturing. Manufacturing processMaximum flexibility to accommodate various requirements Analytical TestingAnalytical methods to support ADC DS characterization and release of DS We are committed to staying at the forefront of advanced ADC technology by making active investments through the Samsung Life Science Fund and securing future partnerships.

development experts help you expedite development journey.S-DUAL™DEVELOPICK™Content TabS-DUAL™DEVELOPICK™The choice for your next dual-specificity therapeuticsThe choice for your next dual-specificity therapeuticsS-DUAL™ is an advanced, high-yield bispecific antibody platform designed to meet your needs and generate perfect pairing every time. The innovative dual-specificity of bispecific antibodies opens up a wide range of applications, enabling clients to reach commercialization much more efficiently.Asymmetrical StructureClear separation of initial impuritiesEasy in-process control during manufacturingLow Immunogenicity RiskSimilar structure to typical bispecific antibodiesAntibody-derived protein onlyCorrectly Paired bsAbKnob-into-Hole CH3 dimer applied on an additional domain in one Fab arm>95% purityStreamlined AccessFavorable contract terms with competitive pricingOnly Parental antibody sequences needed to develop BsAbClick for more informationLate Discovery1 Month (including vector construction)S-DUALTMProprietary Bispecific Antibody PlatformAsymmetric IgC-like structureLow immunogenicity riskCorrect HC & LC pairingStreamlined Access1 Month Small scale Ab productionSmall scale Ab productionSmall scale Ab production with transient expressionAdditional material can be produced for supplemental studies1 Month Developability AssessmentDEVELOPICKTMDevelopability assessmentThermo-stabilityAggregationPurity ProfileConcentrationIND / BLA ApprovalTime & cost for drug developmentoptimized with DEVELOPICKTMEnsure success from an early stageTimely EvaluationReceives results in just 1 monthEfficient AssessmentRequires 20mg of material onlySystematic Scoring SystemGuides you to the optimal decision Samsung Biologics’ DEVELOPICK™ provides early insight and selection guidance to your time and cost to maximize efficiency.Our proprietary platform ensures your path to development success by implementing systematic approach to predict candidates with the best potential for advancement.DEVELOPICK ™Small scale Ab production1 Month Small scale Ab productionAsymmetric IgC-like structureLow immunogenicity riskCorrect HC & LC pairingStreamlined AccessDEVELOPICK ™Developability assessment1 Month Developability AssessmentThermo-stabilityAggregationPurity ProfileConcentrationCell line development to CommercializationTime & cost for drug development optimized with DEVELOPICKTMUse of S-CHOice® cell line for a stable cell line developmentIND / BLA ApprovalAccelerate your journey withKnowing the right candidate with the highest possibility for success is critical for continuing your journey to IND, BLA, and beyond.1 Material production with transient expression / bulk pool material (optional)2 Developability assessmentLeverage our expertise to enable clear and informeddecisions for your development candidateswith DEVELOPICK™3 Go/No-Go decision for cell line development4 Samsung Biologics’ CDMO service (CLD to IND)Developability Assessment WorkflowMaterial supplyBasic Characteristic Analysis(DSF* & DLS**)Heat Stress TreatmentLow pHTreatmentSEC-HPLECE-SDS (NR)Data Summarization& Evaluation*DSF : Differential Scanning Fluorimetry**DLS : Dynamic Light ScatteringRelated ContentsWebinarsNew Approaches in Bispecific Antibody DevelopmentFeb 20, 2023In this webinar in collaboration with Contract Pharma, Jina Kim, our Senior Scientist at our Bio R&D Center, shares insights about new approaches in bispecific antibody development while introduciSamsung BIO InsightExploring Samsung Biologics’ CDO capabilities | Bispecific antibodiesNov 29, 2022 Driven by advances in biotechnology, biopharmaceuticals are among the most sophisticated achievements of modern science and have become central to the industry. Antibody therapies, making up the largPostersSamsung Biologics Developability Assessment Plaform: DEVELOPICK™ for Rapid and Accurate Evaluation of Thermal and Chemical StabilitySep 16, 2022WhitepapersFundamental Considerations for Bispecific Antibody-based Cell

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 Finishing Fully Automated Visual Inspection Secondary Bulk Packaging Storage& Shipping 2-8 ℃ to -70 ℃ Storage Options Passive and Active Shipping Options Regulatory Support Approved in over 20 Global Markets Type V DMFFull CMC end-to- end support 1 / 5 Client 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 blockbustersuccess 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.On Time, In Full; every time, all the time. Adaptability Whether you are moving your product from the benchtop or from another facility around the world, don’t worry.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. pause

development & manufacturing of your product. We are committed to operational excellence in cGMP manufacturing and quality assurance to deliver value to our clients. Samsung Biologics' Values for Customer SatisfactionFully integrated CDMOservice offerings at a singlemanufacturing complexDedicated projectmanagement to overseethe whole lifecycleRegulatory supportwith strong IP protectionCompetitive pricing &flexible business termsOn time,in full deliveryClinical ProductionEarly clinical material production involves a number of risks and uncertainties. We are committed to provide precisely tailored solutions to mitigate such risk, with our strong drug development capability and flexible capacities. CommercialProductionThe market dynamics of rising competition in biologics require drug developers to devote considerable efforts to be more methodical and cost-effective in manufacturing. Samsung Biologics is able to achieve fast turnaround with economy of scale to deliver high-quality products to market, on time. Aseptic FillingSterile filling is one of the most critical steps in the drug manufacturing process relative to overall patient and product safety. Our clinical and commercial fill/finish services ensure you are consistently supplied with the highest possible quality, everytime, all the time.

Development We make it work - for every molecule Our development experts with extensive experience in molecule development are dedicated to ensuring your smooth transition from discovery to clinical. Based on the comprehensive understanding of each molecules’ unique characteristics, our team identifies highly effective end-to-end process and manages a seamless transition while completing the Cell Line Development (CLD) at the same time. Standard TimelineCell Line DevelopmentProcess Development (3.5 months)Upstream Process : Analytical Tech Transfer, CGMP DS Lot Release Downstream Process : cGM P DP Lot R eleaseFormulation : Non-GMP DS/DP, CGMP DS, CGMP DPAnalytical MethodDocumentation for IND Filing Process DevelopmentUpstream Process Our development experts with extensive experience in molecule development are dedicated to ensuring your smooth transition from discovery to clinical. Based on the comprehensive understanding of each molecules’ unique characteristics, our team identifies highly effective end-to-end process and manages a seamless transition while completing the Cell Line Development (CLD) at the same time. Downstream ProcessOur DSP team is equipped with pioneering lab capabilities and up-to-date techniques. In addition to our expertise in DSP, we have also developed a streamlined scheme for non-GMP toxicology manufacturing, help steering your development journey. FormulationOur formulation team is filled with high-quality subject matter experts (SMEs) who are leading the latest techniques and industry trends. Our commitment to exceeding our customers’ expectations is at the forefront of everything we do.Analytical MethodWith a well-developed strategy for method development and a high performance, our analytical method development team is dedicated to delivering reliable results possible. We use state-of-the-art instrumentation and the latest techniques to ensure the quality of our analytical data.

development platform which CHO-K1 cells, with GS knock-out system.This development platform incorporates the latest technology including the Beacon™ system, to ensure the highest accuracies and accelerated timelines. Commercial terms are competitive, with no revenue based royalties. Our platform utilizes state-of-the-art equipment and technology, deep experience and technical knowledge to ensure the delivery of top-quality medicine in record breaking time.With right-first-time and proven experience, we have been able to redefine the actual speed to delivery of medicine and biologics. The best choice to start your therapeutics development journey At Samsung Biologics, we understand the importance of optimal cell line development in the successful navigation of clinical trials and challenging regulatory approval process. With our deep expertise and commitment to excellence, we help you reduce time to market and keep costs low, all while achieving the best possible outcomes for your journey. High-performing CHO-K1-based cell line development platform Samsung Biologics’ Cell Line Development service offers clients a cell line process that combines world-class technology, a strategic mindset, and a collaborative spirit to deliver maximized titers and enhanced cell viability. S-CHOice® builds on glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line technology and shows improved titers reaching above 7 g/L for standard monoclonal antibodies. The cell line also shows enhanced viability with over 90% at day-21 in a fed-batch study. Upstream Process Development - Optimization * Delivers high productivity with 7+g/L titer** Maintains > 90% cell viability through Day 21 Find out how Samsung Biologics transforms cell line development for higher titer Find out how S-CHOice® demonstrates superior titer in comparison to others with MSX: MSX + S-CHOice® vs. MSX + Others Single Cell Cloning with Beacon® - Screen the right cells with precision Efficient screening of a large number of cells and increasing the chances of identifying high-yield/high-quality cell lines are essential for high throughput. While selecting the handful of cells that are most important can take 2-3 months of intensive and expensive manual manipulation. Enhanced by the innovative Beacon® platform, we develop high-yield/ high-quality cell lines within a shorter timeframe. Berkeley® Light Beacon* Fully automated live cell isolation, selection, and screening in nanopens Screen 5,000 individual cells to find the best secretorsEfficient down selection on unstable clonesAutomated monoclonality process with visual record at > 99%Beacon is a registered trademark of Berkeley Lights, Inc. Related Contents WebinarsNew Approaches in Bispecific Antibody DevelopmentFeb 20, 2023In this webinar in collaboration with Contract Pharma, Jina Kim, our Senior Scientist at our Bio R&D Center, shares insights about new approaches in bispecific antibody development while introduci Samsung BIO Insight Exploring Samsung Biologics’ CDO capabilities | Bispecific antibodiesNov 29, 2022 Driven by advances in biotechnology, biopharmaceuticals are among the most sophisticated achievements of modern science and have become central to the industry. Antibody therapies, making up the larg PostersSamsung Biologics Developability Assessment Plaform: DEVELOPICK™ for Rapid and Accurate Evaluation of Thermal and Chemical StabilitySep 16, 2022 PostersEfficient Management of Downstream Process Characterization at Samsung BiologicsSep 16, 2022 WhitepapersFundamental Considerations for Bispecific Antibody-based Cell Line DevelopmentJun 21, 2022 WHITE PAPER Fundamental Considerations for Bispecific ntibody-based Cell Line Development Seahee Kim Head of Cell Line Development The innovative dual specificity of b PostersSamsung Biologics Bispecific Antibody PlatformMay 26, 2022 Bispecific An

Development Services Agile. Flexible. Focused on You.Advanced TechnologyProprietary Cell Line, S-CHOice®Proprietary Bispecific Platform, S-DUAL™Systematic Developability Assessment, DEVELOPICK™Diverse PortfolioBreadth of experience with a wide range of molecule types including monoclonal antibody, bispecific antibody, fusion protein, recombinantsTailored utionDedicated project management team to ensure a smooth transition from discovery to clinical 1 / 3Bring your sequence, we’ll take you to INDFrom development to clinical and commercial, we work with commercialization in mind. Our development experts generate and optimize scalable, robust process for reliable support of our clients’ clinical and long-term commercial supply.By connecting all aspects of development to clinical and commercial production, we are able to achieve optimal yield, quality, and stability for a reliable clinical supply.DiscoveryS-DUAL™ - Bispecific Antibody PlatformDEVELOPICK™ - Developability Assessment PlatformCell Line DevelopmentS-CHOice® and CHOZN® PlatformsHigh productivity with titers up to 7.0g/LProcess DevelopmentMedia screening and process optimizationBuffer and excipient screeningAssay development and characterization studiesNon-GMP DS/ DP ProductionScale: 50L or 200L bioreactorsNon-GMP DS/DP stability data to support CGMP DS/DP stabilityCGMP DS/ DP ProductionScale: 200L and 1,000L bioreactorsDS/DP stability studyIn-house, clinical- scale DS/DP manufacturingIND Filing SupportIND/IMPD CMC documentation supportIND filing support with Module 2.3 & 3 of CTD and Type V drug Master FileClinicalRelated ContentsWebinarsNew Approaches in Bispecific Antibody DevelopmentFeb 20, 2023In this webinar in collaboration with Contract Pharma, Jina Kim, our Senior Scientist at our Bio R&D Center, shares insights about new approaches in bispecific antibody development while introduciSamsung BIO InsightExploring Samsung Biologics’ CDO capabilities | Bispecific antibodiesNov 29, 2022 Driven by advances in biotechnology, biopharmaceuticals are among the most sophisticated achievements of modern science and have become central to the industry. Antibody therapies, making up the largPostersSamsung Biologics Developability Assessment Plaform: DEVELOPICK™ for Rapid and Accurate Evaluation of Thermal and Chemical StabilitySep 16, 2022PostersEfficient Management of Downstream Process Characterization at Samsung BiologicsSep 16, 2022 WhitepapersFundamental Considerations for Bispecific Antibody-based Cell Line DevelopmentJun 21, 2022 WHITE PAPER Fundamental Considerations for Bispecific ntibody-based Cell Line Development Seahee Kim Head of Cell Line Development The innovative dual specificity of bPostersSamsung Biologics Bispecific Antibody PlatformMay 26, 2022 Bispecific Antibody Platform A Novel Asymmetrical Structure for Therapeutic Antibodies An emerging class of next-generation antibody therapy, bispecific antibWebinarsAccelerated High-performing Platform Process of Monoclonal Antibody: Upstream Optimization Case StudyMay 17, 2021Selecting the right CDMO partner is critical for any institution as the decision can impact product quality, cost and timeline. This presentation will delve into the CDO Upstream Process at Samsung BiWebinarsWhat to consider in selecting the best cell line to accelerate the timeline to INDApr 19, 2021The start of a biologic’s developmental journey is represented with cell line development. During this exciting milestone, a suitable cell line must be selected for optimizing the remaining processesSamsung BIO InsightThe Journey to Your Success | Explore Samsung Biologics' CDO StrengthsAug 31, 2021 Biologics are complex, large-molecule substances* that require controlled processes and up-to-date technology to develop. An excellent understanding of the scientific, logistical, and regulatory chalSamsung BIO InsightExploring Samsung Biologics’ CDO capabilities | Bispecific antibodiesNov 29, 2022Driven by advances in biotechnology, biopha