SERACH RESULTS FOR" Development "
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.News BriefSamsung Biologics to attend DCAT Week, expand U.S. presence with New Jersey siteMarch 21, 2023Samsung Biologics is participating in DCAT Week 2023 from March 20 to 23. Kevin Sharp, VP and Head of Samsung Biologics America Sales, will talk about the company’s manufacturing capacity expansion plans in a speaking session during the Member Company Announcement Forum at the event. News BriefSamsung Biologics shares 2023 business plans at 41st Annual J.P. Morgan Healthcare ConferenceJanuary 12, 2023Samsung Biologics shared its 2023 business plans and vision at the 41st Annual J.P. Morgan Healthcare Conference, taking place between January 9-12 in San Francisco, California, USA. During the main track presentation today, John Rim, CEO and President of Samsung Biologics said the company will build on the strong growth momentum in 2022 with continued investments to further solidify its global position.Media Focus#CPHI22: As Samsung’s new plant comes online, it looks to expand in Korea and beyondDecember 2, 2022It is no secret that the CDMO arm of one of South Korea’s largest conglomerates has been expanding in 2022. In the middle of the year, Samsung Biologics was going to see a bump in funding from the Samsung group and now has committed to boosting its presence in South Korea and beyond.Press ReleasesSamsung Biologics unlocks additional capacity for production at its newest Plant 4October 11, 2022Incheon, S. Korea, October 11, 2022 – Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), announced today that its Plant 4 – the world’s largest single bio manufacturing plant – has commenced GMP operations this month.Media FocusFor $323M, Samsung Biologics buys land for a 2nd manufacturing campus in South KoreaAugust 5, 2022 Samsung’s expansion plan for its CDMO unit is an efficient, no-nonsense enterprise, marching on with no end in sight.Maybe that’s why, at its home base in South Korea, Samsung Biologics refers to its factories by number. Just 11 years into its existence, Samsung has Plants 1, 2 and 3 in operation, Plant 4 under construction and Plants 5 and 6 on the drawing board.Media FocusSamsung Biologics speeds $2B plant build forecast to boost capacity 70%August 10, 2022Samsung Biologics is pushing for early completion of its new $2 billion manufacturing facility in an effort to meet increased demand and boost the South Korean CMO giant’s profits.
development and manufacturing. Plant1 30KL, Plant2 154KL, Plant3 180Kl, Plant4 240KLMultiple scales, multiple capacities to fitvarious processes for any production volumeTotal Capacity604KLPlant 130,000L5KL x 6Plant 2154,000L15KL x 101KL x 2 (Stainless Steel)1KL x 2 (Single-Use)Plant 3180,000L15KL x 12Plant 4240,000L15KL x 1210KL x 6TechnologiesN-1 perfusionHigh cell density continuous production with both TFF and ATF systems100% WFI dual supplyEliminates risk of production disruption due to water supplySimultaneous operationAccelerates manufacturing to satisfy large product demandFeaturesData integrity ensured via Pharma4.0 enabled technologiesSolar power generator installed on roof areasMultiple operation modes for production efficiency
development and manufacturing of biopharmaceutical products. We offer a fully integrated service at a single site - a seamless solution that accelerates your discovery from early development through clinical and commercial manufacturing.Bio Campus I 604KL - moreBio Campus I 604KL - factoryBio Campus II*720KL - moreBio Campus II*720KL - factoryBio Campus I 604KLPlant 130,000LPlant 2154,000LPlant 3180,000LPlant 4240,000LBio Campus II*720KL* to be completed by 2032Technologies & FeaturesAccessibilityFull in-house capabilities at a single siteMulti-scale manufacturingReal-time client accessEfficiencyEnd-to-end offeringSimultaneous operationMultiple operation modesSustainabilityCarbon neutralSolar power generatorReusable water treatment systemDigitalizationDigitally optimized smart labReal-time data sharingEnterprise Quality Unified Information System (EQUIS)
development in support of client pipelines. As your next-door CDMO partner, we help start your journey from gene to IND. Operations at the San Francisco R&D Center are tightly coordinated with Samsung Biologics headquarters based in Songdo, South Korea, so that our partners can have access to the full capabilities and capacity of a best-in-class global CDMO. Service & Facility The San Francisco R&D Center uses industry-standard equipment, including Cytena Single Cell Printer and Solentim Cell Metric, to perform Cell Line Development (CLD) as fast as 14 weeks (or 3.5 months). Samsung Biologics offers its own proprietary cell line development technology S-CHOice, which builds on glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line technology and shows improved titers up to two-fold from the industry average, reaching above 7 g/L for standard monoclonal antibodies. Our high expression cell line maintains viability over 90% at day-21 in a fed-batch study, demonstrating effectiveness in producing high quality cell lines. Transfect CHO GS KO host with vectorStable pool generation & selection of high-producing pools ~7 weeksSingle cell cloning ~ 3 weeksStable clone generation and RCB selection ~ 4 weeks Directions to San Francisco R&D Center 600 Gateway Blvd., South San Francisco CA 94080 / +1-650-898-9717 Contact us at email@example.com zoom in
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.Mr. Rim holds a bachelor’s degree from Columbia University, a master’s degree from Stanford University, and an MBA from the Kellogg School of Management at Northwestern University.Read a message from the CEOJames ParkExecutive Vice President & CBOJames Park is Executive Vice President and Managing Director of the Global Sales Center.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. Mr. Park 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.Pierre CatignolExecutive Vice PresidentPierre Catignol is Executive Vice President and Head of Manufacturing center at Samsung Biologics.Mr. Catignol has over 25 years of experience in the biopharmaceutical and pharmaceutical industry.Prior to joining Samsung Biologics, Mr. Catignol began his career at Sanofi-Pasteur in 1995, and extended his career in StALLERGENES AND VIRBAC as Head of Operations & Supply site and Operations & Quality respectively.His recent leadership role was at Lonza as Head of Portsmouth site.Mr. Catignol holds a master's degree for General Engineering at ECAM university.Kun Lo, Ph.D.Executive Vice PresidentDr. Kun Lo is Executive Vice President and Head of EPCV center responsible for construction and operation of new plants.Prior to joining Samsung Biologics in 2020, Dr. Lo held various management positions in Engineering and New Business.Dr. Lo began his career with Samsung General Chemicals in 1992, then developed chemical products and managed manufacturing for 18 years in Samsung Total Petrochemical. In 2013, Dr. Lo advanced through Engineering expertise as a manager of Engineering Support Team and Process Design in Samsung Engineering.Dr. Lo assumed responsibilities for planning global business as a New Business Team Leader and Head of US corporation in Samsung Engineering.Dr. Lo holds a doctor’s degree from Seoul National University in Chemical Engineering.Sam MachourExecutive Vice President & CQOSam Machour is Executive Vice President and Chief Quality Officer in charge of Quality, Regulatory and Compliance at Samsung Biologics.Prior to joining Samsung Biologics in 2019, Mr. Machour spent more than 32 years supporting MedTech, bioscience and biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Regulatory, Operations and product commercialization.Mr. Machour served at several big pharma including Pfizer, GSK and J&J and held global leadership roles at Lonza as its Vice-President and Global Head for Quality and Regulatory and member of the Biolog
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 Partnership with Eutilex 20182018OCT.AEO Certification OCT.Plant 3 cGMP Ready JUL.First DP Approval by FDA Manufacturing Partnership with UCB Development Partnership with GI Innovation First Approval of Plant 1 by Health Canada APL.SO 22301 Certification (BCMS) 20172017NOV.Plant 3 Mechanical Completion OCT.MOU for Strategic Alliance with Merck SEP.First Approval of Plant 2 by FDA JUL.Manufacturing Partnership with Sun Pharma MAY.First Approval of Plant 1 by PMDA 2015-Now2013-20162011-2013Samsung’s Innovative Design PLANT 2 - The Largest Single Plant5X Scale(DS 15,000L + DP Fill/Finish)Total Capacity - 152,000L(10x15,000L / 2x1,000L)Construction - 29 monthsto cGMP ready20162016NOV.Samsung Biologics IPO on KOSPI First Approval of Plant 1 by EMA FED.Plant 2 DS cGMP Ready 20152015NOV.First Approval of Plant 1 by FDA Plant 3 Construction Started OCT.Plant 1 PLI Approval FEB.Plant 2 Mechanical Completion APR.Manufacturing Partnership with BMS 20142014APR.Manufacturing Partnership with BMS 2015-Now2013-20162011-2013Standard Design PLANT 1 - Industry StandardIndustry Average Scale(DS 30,000L + DP Fill/Finish)Total Capacity - 30,000L(6x5,000L)Construction - 25 monthsto cGMP ready20132013OCT.Manufacturing Partnership with Roche SEP.Plant 2 Construction Started AUG.Plant 1 DP cGMP Ready JUL.Manufacturing Partnership with BMS JUN.Plant 1 DS cGMP Ready 20122012JUL.Plant 1 Mechanical Completion 20112011MAY.Plant 1 Construction Started APR.Foundation of Samsung Biologics
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