manufacturing capability that is always ready for on-time customer satisfaction.Custom mRNA ServicesWith highest-level compliance and a dedicated team of mRNA experts, Samsung Biologics accommodates your needs by providing customized services for any scale-up study in mRNA and lipid nanoparticle (LNP) production.ScopemRNA / saRNA / circRNAIVT* Batch Capacity0.1 L to 200 L Single-use*In vitro transcriptionAgile mRNA Development ServicesWith our fully integrated solutions for mRNA GMP manufacturing that span process/method development, process/product characterization, and analytical testing, we help steer your innovative therapeutic through clinical and commercial stages.ProcessAnalyticsCGMP mRNA / LNP DSmRNA / LNP Process DevelopmentMethod Development / QualificationNon GMP mRNA / LNP DSMethod Transfer to QCProcessmRNA / LNP Process DevelopmentNon GMP mRNA / LNP DSAnalyticsMethod Development / QualificationMethod Transfer to QCCGMP mRNA / LNP DSSeamless CDMO Tech TransferFlexible scale-up precisely tailored to your needsIn the rapidly evolving mRNA industry where early-phase materials dominate, agile and swift small-scale production for clinical studies is essential. Samsung Biologics is ready for both current and future demands, offering seamless tech transfer with flexible scale-up from lab to commercial levels tailored to your needs.One-stop mRNA Manufacturing ServicesFrom pDNA linearization to fill & finish, Samsung Biologics uses flexible solutions and proven expertise to commit to an on-time, in-full delivery of mRNA vaccines and therapeutics we manufacture.Automated WarehouseLabeling & PackagingAseptic mRNA fillingLNP Purification (TFF)LNP FormulationmRNA Purification(UFDF, Chromatography)mRNA Synthesis IVT C/TpDNA- LinearizationpDNA- LinearizationmRNA Synthesis IVT C/TmRNA Purification(UFDF, Chromatography)LNP FormulationLNP Purification (TFF)Aseptic mRNA fillingLabeling & PackagingAutomated WarehouseIn-house Bioanalytical Services for GMPOur customized quality control services for mRNA in vitro transcription (IVT), LNP, and fill-finish are conducted fully in-house, enabling swift release without undue delays.IPC* Testing• Physical chemistry-based assays• Mass-based assays• Plate reader-based assays• Cell-based assaysRelease Testing• In-process control• Compendial testing• Microbial identification• Sterility testing• CCIT/Extractable volume• Particulate testingBiosafety Testing• Bioburden testing• Endotoxin detection and quantitation*In-process controlInnovative Scientific SupportProprietary sequence design features ranging from untranslated regions to unique poly(A) tail structures provide both contract research service and research collaboration opportunities. Tackling complex synthesis and purification processes can be customized for project-specific requirements.mRNA sequence design• AI-based optimal sequence design algorithm platform with in-silico and in vitro validation• Customized mRNA sequence design service with improved protein expression profile and mRNA stabilityPoly(A) tail shield• Proprietary mRNA tail sequence and structure with manufacturing advantages• Recombination-resistant design and QC-friendly homopolymeric characteristicscircular RNA (circRNA)• Manufacturing platform for novel forms of RNA structure• High circularization efficiency and purification of biologically active fractions

manufacturingsite and is supported by the robust GMP systems established for our existinghigh-capacity clinical and commercial biologics manufacturing. Dedicated FacilityExpedited DS delivery with flexibility at a single siteExpertise in quality and proven operational track recordIntegrated systems with established tools and proceduresStable supply chain management system FeaturesSingle-use and stainless steel reactors(Up to 500L conjugation train)Full-scope laboratories for 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.

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 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 in

manufacturing of drug substance in multiple scales and capacity. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A bulk filling capacity, as well as product pool vessel capacities from 200 liters to 15,000 liters to handle a wide range of pool volumes. Small Scale Equipped with a wide range of bioreactor sizes as well as new manufacturing technology, we offer multiple CGMP manufacturing facilities to deliver the production volumes required by our clients at any given time. Our small-scale manufacturing facility has the same best-in-class characteristics and equipment as our large-scale plants, featuring stainless steel and single-use bioreactors at 1,000 liter scale, and one purification suite with pre- and post-viral segregation. Multiples Scales, Multiple Capacities,to fit various processes for any production volume sCMO4,000L Plant 130,000L Plant 2150,000L Plant 3180,000L 1 * Plant 3 has Fed-batch with N-1 Perfusion Capability

Manufacturing, Quality & Compliance, and Analytical 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.

manufacturing to a CMO.Samsung Biologics was founded on the simple principles of providing better services with higher speed and flexibility at the most competitive pricing, all while maintaining top quality and full regulatory compliance. With these principles, we are committed to re-invent the CMO client experience and provide you with the highest level of satisfaction in the industry. Whether your needs be in fill-finish of monoclonal antibodies, vaccines, or small molecule drugs, we are here to help. Aseptic Filling Small & Large Scale Clinical & Commercial Vials & Syringes Biologics & Small Molecules Lyophilization Small & Large Scale Clinical & Commercial Cycle 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

Manufacturing Services Overview True Partner forYour Entire JourneySamsung Biologics is a reliable partner for seamless tech transfers, clinical & commercial manufacturing, aseptic fill/finish and analytical testing. From the beginning of our partnership, you will have a dedicated project management team to walk you through the entire journey of the product 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.

Manufacturing Small ScaleManufacturing As the world’s largest CDMO, we offer multiple cGMP manufacturing facilities to meet the diverse scales of our clients’ demands. The Small scale manufacturing Facility has the same best-in-class characteristics and equipment as our large-scale capacity. CMP 1 Flask Culture 20L(N-3)(nominal volume)Wave bioreactor 40L(N-2)(W.V)Seed bioreactor 200L(N-1)(W.V)Seed bioreactor 1000L(N)(W.V)Production bioreactor* 2 CMP 2 Flask Culture 20L(N-3)(nominal volume)Single use bioreactor 50L(N-2)(W.V)Seed bioreactor 200L(N-1)(W.V)Seed bioreactor 1000L(N)(W.V)Production bioreactor* 2

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.

So S-CHOice® is our high-performing proprietary cell line 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 Biologic

ManufacturingCustomized CMC SolutionsSelecTailor™From Gene to IND- Claim your bespoke packageEquipped with a range of comprehensive service options that align with your specific development strategies, Samsung Biologics offers tailored solutions to best guide your development journey. With our partnership, you will have access to in-depth knowledge and know-how for your molecule's unique characteristics.Every biologics development journey is unique and complex. Therefore, flexible approaches are essential to paving the way into the clinic. Leveraging our diverse portfolio and proprietary platform processes, our team of experts will help you de-risk your journey while minimizing costs.Simplified INDExpedite timeline focused on IND Phase 1 by utilizing Samsung Biologics' platformComprehensive INDLeverage wider scopes of study to mitigate the risk for developmentEnhanced CMCReplace cell line/process/formulation to improve key features