SERACH RESULTS FOR" Manufacturing "
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 Biologics Executive Committee and at Becton Dickinson as the Global Vice-President of Quality Operations, in charge of Quality, Regulatory and Compliance.Mr. Machour is Director of Executives Without Borders, is a member of the Africa CDC Partnerships for African Vaccine Manufacturing (PAVM) and is the Vice-Chair, in Korea, of the George Mason University Advisory Committee, helping improve the delivery of education.Andy Yongsin KimExecutive Vice PresidentAndy Yongsin Kim is Executive Vice President and Head of Business Operation center at Samsung Biologics.Prior to joining Samsung Biologics in 2010, Mr. Kim was at Samsung Electronics, where he began his career in 1987, as Director of Human Resources for the Visual Display Division.Most notably, Mr. Kim carried out his duties from 2004 to 2009 by establishing Samsung’s new brand presence in three countries in Eastern Europe (HU,CZ,SK), supporting sales & manufacturing, and overseeing all HR affairs.Sangyoon Lee, Ph.D.Vice PresidentDr. Sangyoon Lee is Vice President and Head of Technology Support center at Samsung Biologics.Prior to joining Samsung Biologics in 2021, Dr. Lee held various management positions in Technical Operations and Manufacturing.Dr. Lee began his career in the pharmaceutical industry in 2004, overseeing Technical & Supply Operations and Drug Product Manufacturing where he was promoted to Senior Vice President to lead the Global Operations Division in 2019.Dr. Lee holds a Ph.D. in Bioengineering.Dongjoong KimExecutive Vice President & CFODongjoong Kim is Executive Vice President and Managing Director in charge of the Business Support Center which includes the Finance Team, Business Strategy Team and Business Plan
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
Manufacturing Partnership with CytoDyn MAR.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
manufacturing which requires prolonged periods of cell culturing, mRNA drug substance production is a cell-free process that involves linearization of plasmid DNA(pDNA), mixing it with enzymes and nucleotides to allow for its transcription into mRNA, and mRNA capping, etc.※ Samsung Biologics will add mRNA vaccine DS production capability to its existing facility by the first half of 2022. Manufacturing Process mRNA production begins with in-vitro transcription, where the linearized pDNA is synthesized to form mRNA in a reactor. Then, the mRNA is purified in steps involving chromatography and ultrafiltration(UF)/diafiltration(DF) to prepare for the formulation stage. Finally, the purified mRNA is encapsulated into Lipid Nanoparticles (LNP) through precise pump mixing technology to prevent degradation and to allow for in vivo delivery. Storage Because a mRNA is susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Samsung Biologics is able to meet such challenges though its upright and walk-in storage systems with temperature as low as -70°C as needed How a mRNA vaccine is made DNA Enzymes + Buffers + Nucleotides = mRNA mRNA+LNP Drug product Why Samsung Biologics? As the global biologics market gets more competitive, clients' needs and market uncertainty is growing more than ever before. Samsung Biologics promises that your invaluable molecule will be delivered to the market safely and quickly. Whether you are looking for standalone services or a seamless, integrated manufacturing service from clinical to commercial, we are focused on providing an unsurpassed level of customer service dedicated to the needs of our individual customers. We believe and are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions and proven expertise. Fully IntegratedOne Stop Service Offering services from clinical to commercial manufacturing with dedicated QC lab and RA support Modernized Stateof the Art Facility Newly built facilities fully compliant with cGMP that guarantee you the best environment for your product PromptResponsiveness We value your time andpromise a prompt response Flexibility from1K to 15K With various different scales, we have a solution for you 1 / 4
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
ManufacturingQualityEngineeringManagement Support Content tab ManufacturingQualityEngineeringManagement Support Manufacturing Manufacturing Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial management and ValidationDistribution ManagementValidation Quality Quality Quality ControlQuality Assurance Quality ControlQuality Assurance Engineering Engineering Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Management Support Business Development Business DevelopmentBD Planning Corporate Business Operation PlanningProcurementLegal & CompliancePR Corporate management FinanceInformation TechnologyHuman resources Business DevelopmentBusiness DevelopmentBD Planning Corporate Business OperationPlanningProcurementLegal & CompliancePR Corporate managementFinanceInformation TechnologyHuman resources Application Method Register your CV in our Talent Pool system and we will contact you if and when your preferred position or a position that matches your previous career experiences becomes available. Efirstname.lastname@example.org Passing of the application procedures and employment may be cancelled if the contents of the application form are found to be false.※ Download Application Form Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
ManufacturingQualityEngineeringManagement Support Content tab ManufacturingQualityEngineeringManagement Support Manufacturing Manufacturing Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial management and ValidationDistribution ManagementValidation Quality Quality Quality ControlQuality Assurance Quality ControlQuality Assurance Engineering Engineering Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Management Support Business Development Business DevelopmentBD Planning Corporate Business Operation PlanningProcurementLegal & CompliancePR Corporate management FinanceInformation TechnologyHuman resources Business DevelopmentBusiness DevelopmentBD Planning Corporate Business OperationPlanningProcurementLegal & CompliancePR Corporate managementFinanceInformation TechnologyHuman resources Application Method Register your CV in our Talent Pool system and we will contact you if and when your preferred position or a position that matches your previous career experiences becomes available. Eemail@example.com Passing of the application procedures and employment may be cancelled if the contents of the application form are found to be false. Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
manufacturing/production of commercial drugs, aseptic filling (DP) and analysis testing.- We introduce our service to clients. Dedicated project managers for each client are involved in entire process from product development to product manufacturing. R&D More Close - We develop and optimize extensible and stable process to supply drugs for commercial and clinical use in stable and constant manner.- Our service includes cell culture / development of downstream process, analysis methods and dosage form.- SBL develops an integrated process by reflecting all aspects of development into clinical and commercial manufacturing. Quality More Close - We guarantee high quality process and facility management that are engaged in our business plan.- Quality experts comply with regulation standards and promote a culture of quality compliance. Manufacturing More Close - We develop safe and trustworthy clinical and commercial biopharmaceuticals, and provide manufacturing service within cutting-edge production facilities that comply with strict cGMP standard- All processes are conducted in compliance with cGMP standard and high standards required by authorities. Manufacturing Support More Close - SBL provides an end-to-end service for clients who want CMO or CDO services- Our manufacturing process starts from equipment validation to process development. EPCV More Close - We support entire teams so that SBL becomes the largest biopharmaceutical manufacturing facility in the world. SCM More Close - We make sure important raw materials for drug manufacturing are stably supplied and manufactured products are well delivered to clients. Business Administration More Close - We support our teams from back office. Our roles include HR, finance, legal and etc. with which we help to deliver value to clients based on outstanding cGMP expertise and quality assurance system. Please select your interests. Please select your interests.Sales & Marketing, R&D, Quality, Manufacturing Support, EPCV, Supply Chain, Business Administration Sales & Marketing PR Sales Support Project Management R&D CDO Quality Quality Control Quality Assurance Manufacturing Cell Culture Purification Fill & Finish Manufacturing Support Process Development Manufacturing Technology Validation EPCV Equipment Technology Engineering Technology Engineering Project Management Supply Chain Procurement Material Management Business Administration Business Strategy Information Security Legal & Compliance IR Finance IT Human Resources Safety Health Environment Management
Driven. For a Sustainable Life. Samsung Biologics aspires to lead the industry in protecting our planet for the health of future generations. In our mission to enrich human life while creating enduring and sustainable value, we are investing in practices and technologies to mitigate the risks of climate change in the greater areas we impact. As a global CDMO partner, we recognize the greater impact we can have by working together, and essential to our decarbonization is the cooperation and engagement with our suppliers to accelerate the net zero transition across our supply chains. A blossom of hope We are on a journey to help create a healthier adn sustainable future. Our path to changing the world is never ending. It touches everyone and everything. Together we are Driven. For a Sustainable Life. Driven. For Life. Samsung Biologics ESG Report We're committed to sharing oursustainable progress and goals.Learn more about our sustainability initiatives. Find out more Our InvolvementsWe are committed to global carbon neutrality SMI Sustainable Markets Initiative(SMI) A low-carbon transition engagement led by the British royal family,Samsung Biologics participated as a representative of the global CDMO industryto seek a net-zero supply chain plan Find out more on the SMI website The SMI was launched by HRH The Prince of Wales at the World Economic Forum in 2020. It aims to lead the transition to a sustainable future by convening leaders to bring economic value into alignment with social and environmental sustainability. In 2021, the SMI Health Systems Taskforce was formally launched at COP26 in Glasgow including 13 leaders from across the healthcare system with CEOs/equivalents from: AstraZeneca, GSK, Merck, Roche, Samsung Biologics, Sanofi, Novo Nordisk, the World Health Organization, UNICEF, NHS England, the Sustainable Healthcare Coalition, the Karolinska Institute and the University of Pavia. With its shared ambition to accelerate the delivery of net zero, sustainable healthcare to improve individual, societal and planetary health, the SMI Health Systems Taskforce is committed to delivering action in three priority areas through the establishment of Working Groups: Supply Chains (championed by John Rim, CEO Samsung Biologics). The Supply Chains Working Group is focused on accelerating the net zero transition across health systems supply chains. More specifically, the group aims to work with suppliers to decarbonize upstream product supply chains, with a focus on renewable energy, clean heat, green logistics and common supplier standards. Patient Care Pathways (championed by Paul Hudson, CEO Sanofi). The Patient Care Pathways Working Group focuses on identifying opportunities to deliver net zero patient care while improving health and societal outcomes. The group aims to demonstrate how interventions across the care pathway can drive emissions reductions by decarbonizing care settings, preventing and managing disease progression, and delivering lower-CO2 solutions. Digital Healthcare (championed by Belén Garijo, CEO Merck). The Digital Healthcare Working Group focuses on leveraging digital innovation and technology in order to drive the transition to net zero across health systems. The initial focus of the group is on demonstrating how digital solutions can support reducing emissions across clinical trials while improving patient outcomes and the patient experience. Frontier 1.5D The Frontier 1.5D project is a global collaborative effort to limit temperature rise to 1.5°C above pre-industrial levels.Business leaders from Korea have joined with the British Embassy, Ewha Woman’s University, Financial Supervisory Service, to analyze the financial impact of climate response policies in the effort to address uncertainties associated with climate change and collectively thrive for a net-zero future. As a business sector representative, Samsung Biologics wi
manufacturing partner to ensure a stable supply of life-saving drugs, especially in light of the current pandemic. ISO22301 is especially meaningful given our critical mission to the biopharma industry to providing patients with a stable supply of life-saving therapies under any circumstances OverviewOperating system Content Tab OverviewOperating system Overview Business Continuity Management System (BCMS, ISO22301) Samsung Biologics’ holistic management process that identifies potential threats to an organization and the impacts to business operations from such threats; and provides a framework for building organizational resilience with the capability of an effective response that safeguards the interests of its key stakeholders, reputation, brand and value-creating activities. Purpose of BCMS Samsung Biologics is operating Business Continuity Management System (BCMS) to protect the assets of our company and clients from risks and to stably deliver key products and services to patients. Leadership for BCMS Operation Samsung Biologics hereby pledges to protect the assets of our company and clients from risk and to stably deliver key products and services to patients to comply with our Business Continuity Management policy. We strive to identify and evaluate the risk of disruption to Samsung Biologics' activities in order to be a global leading company by implementing processes to prevent and mitigate the impact of disruption through continuous improvement. We establish a dedicated organization to routinely manage and continually improve suitability, adequacy, and effectiveness throughout the entire whole business continuity management process. We pledge to be a reliable company for our clients and shareholders by actively participating in BCM activities to stably deliver key products and services. Samsung Biologics President & CEOJohn Rim ISO22301 ISO22301 is a comprehensive standard published by the International Organization for Standardization (ISO) that represents the highest level of commitment to business continuity and disaster preparedness. Samsung Biologics became the first Korean pharmaceutical company to achieve ISO22301 certificate in 2018, and has continuously expanded the scope of certification for ensuring systemic BCMS management. Operating system BCMS Steering Group Samsung Biologics has three levels of teams in the response structure. The strategic, tactical, and operational teams in a response structure undertake different activities as follows: Crisis Management Committee Emergency Response - Evacuation- Initial Site response- First aid- Restoration- And others Business Support - Supply Chain- HR- Finance- Quality- And others Manufacturing - Drug Substance- Drug Product- Research- Development- And others Communication Communicate to - Client- Staff- Regulatory Agency- Audit committee- Others BCMO The strategic teams,which focuses on strategic issues that impact the organization's core objectives, products and services, are 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 teams,which manage and coordinate the continuity of the processes required to deliver the impacted products and services and ensure that the resources are allocated appropriately, are led by a team leader. Tactical level plans provide a framework to coordinate strategic goals and decisions with the operational response teams. The operational teams,which focus on the continuity of the activities that contribute to the processes that deliver the prioritized products and services, is led by each functional site matter expert. An operational response establishes the necessary capability required to continue delivering priotised products and services. The strategic teams,which focuses on strateg
Manufacturing operations shall be in compliance with the legal requirements of the Safety, Health, and Environment policy. All domestic legal requirements shall be satisfied while the international rules and regulations shall be adhered to as applicable. John RimPresident & CEOSamsung Biologics
manufacturing expertise and R&D capabilities : Fully-integrated CDMO=Integrated Bio-pharmaceutical Company Company Reputation Continuously improved Reputation Release of "2022 ESG Report*, (Jul 11th) Corporate Rating Upgraded by one-grade (A+ → AA-) CMO Leadership award for 9 consecutive years 삼성바이오로직스는 반기 별도 기준 최초로 매출 1조원을 달성했습니다. 오늘 삼성바이오로직스는 2분기 실적을 발표했습니다. 지난 1분기에는 2공장 Slowdown이 있었지만, 2분기에는 전 공장이 안정적으로 가동됨에 따라 생산 및 매출증가로 이어져 상반기 매출 1조원이라는 성과를 이뤄낼 수 있었습니다. 당사는 지난 4월, 유상증자를 성공적으로 마무리한 데 이어 삼성바이오에피스 지분을 인수해 100% 자회사로 편입한 바 있습니다. 이번 실적 발표에는 바이오에피스의 실적도 반영되었으며, 2분기 연결기준 매출 6,514억원, 영업이익 1,697억원을 기록했습니다. 삼성바이오에피스는 우수한 바이오 제약 개발 역량을 기반으로, 더욱 신속하고 유연한 성장 전략을 추진해 포트폴리오 리더십을 지속적으로 확대해나갈 계획입니다. 바이오로직스의 제조 역량과 바이오에피스의 개발 역량이 더해져 더욱 시너지를 낼 수 있을 것으로 기대하고 있습니다. I am very proud to announce that Samsung Biologics, independent of Bioepis, achieved revenues exceeding 1 trillion won for the first time on a half-year basis. This is mainly attributable to the stable manufacturing operations of all plants leading to increased revenue in spite of the scheduled slow-down for regular maintenance in Plant 2 in the 1st quarter. Furthermore, as a result of the acquisition of remaining stakes in Samsung Bioepis completed in April, Samsung Biologics benefitted from the effect from the consolidation of Samsung Bioepis' P/L as a wholly owned subsidiary. Accordingly, we posted a record 2nd quarter revenue of 651.4 billion won and operating profit of 169.7 billion won on a consolidated basis. Driven by our operational excellence and flawless quality and regulatory track record, we have been maintaining solid sales momentum with a robust cumulative backlog. We had already secured contract agreements for 7 products with 5 global biopharmaceutical companies for Plant 4, which is currently under construction and will come on line in October (to be fully GMP ready by mid-2023). At the same time, we are continuously negotiating with global big-pharmaceutical companies for additional pre-sales. Moreover, we signed a land purchase agreement with the Incheon Free Economic Zone (IFEZ) on July 18th to build out our second biocampus, dubbed “Bio Campus II”, to preemptively respond to the changes and needs of the market. Bio Campus II is designed to support Samsung Biologics' plans to establish a foundation for our future growth engine with large-scale manufacturing capacity for monoclonal antibodies, portfolio expansion, and an open innovation facility. We are also pleased to inform you that we successfully completed the purchase of Biogen's stake in Samsung Bioepis and the rights issue in April. With excellence in biosimilars development capabilities, we expect to have our portfolio leadership expanded continuously by pursuing a more flexible and accelerated growth strategy. As an extension of our efforts for sustainable management that began in earnest in 2021, we published our second annual ESG report on July 11th to address a wide range of environmental, social, and governance (ESG) activities that had been carried out in the past year in addition to outlining our plans for the upcoming year. Under our mission of ‘Driven. For a Sustainable Life.', we are continuously improving and committing our resources to create a more sustainable environment, build a healthier society, and implement responsible business activities. We will be steadfastly committed to a wide range of socially and environmentally equitable practices to contribute to society with sustainable growth and development. With our pre-emptive and bold investments backed by solid business execution, Samsung Biologics will continue our path forward from the world's best contract development and manufacturing organization (CDMO) to a fully integrated global bio-pharmaceutical company. I would like to express my deepest gr
manufacturing efficiency across all plants while preparing for the pre-sales and partial operation of Plant 4 in October. In January, to secure future growth engines we announced a capital raise by issuing new shares to existing shareholders and employees. Thanks to our shareholders' strong support, we successfully raised 3.2 trillion won (USD 2.6B), at 639,000 won per share, with a subscription rate of more than 100%. Once again, we would like to sincerely thank our shareholders for supporting us in investing in our sustainable growth. Of the capital raised, we will invest 1.2 trillion won in purchasing Biogen's (50%-1 share) stake in the Samsung Bioepis joint venture, and the remainder will be spent on expanding additi CDMO capabilities, including Plant 4 construction and securing additional land for Bio Campus II, etc. As a wholly owned subsidiary, Samsung Bioepis will have improved agility and autonomy in decision making to accelerate its biosimilar development capabilities and its future growth plans, including novel drug development, etc. SUC CE Thanks to the strong support and interest from shareholders and investors, Samsung Biologics successfully completed the rights offering. In return, we will continue our efforts to take a great leap forward to diversify our business portfolio for sustainable growth and ultimately become a global biopharmaceutical company with great responsibilities to better serve our clients, shareholders, and ultimately society. We greatly appreciate your continued support and interest in Samsung Biologics. Thank you Sincerely, John Rim President and CEO, Samsung Biologics
manufacturing capacity since 2019 and is advancing forward through active investment with unparalleled innovation. We are currently building Plant 4 and will begin construction of Plant 5 this year, which will offer multi-modal product services, venturing into expanding business portfolio for cell and gene therapies and next-gen vaccines utilizing mRNA, PDNA and viral vectors, all at a single site, in addition to mRNA DP and DS manufacturing. We are also in the process of securing additional land of 350,000m2 for Bio Campus II, which will be 30% larger than the size of the current site. At a time of great momentum for change and advancement, your continued support is indispensable. We ask for your continued trust and support for the success of Samsung Biologics. Thank you. Sincerely, 2022.1.28 CEO and President of Samsung Biologics John Rim
manufacturing equipment and process optimization play a significant role in increasing speed to market of critical biologic drugs. In this article, Youlim Kim, our Lead Scientist in Cell Line Development, explores the challenges associated with CLD and offers an expert look into the tactics CDMOs can employ to shorten commercial timelines while preserving quality and yield. Learn more (See page 44-45)
Manufacturing Companies (CDMO)• Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product Boston and Incheon, S. Korea, August 1, 2022—GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA production partnership. Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung’s commercial facility was completed in seven months, demonstrating platform adaptability and scalability. GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA. The company’s RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight’s Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale. “This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and President at Samsung Biologics. Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients. “One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.” To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale.
manufacturing organization, today announced strong financial results for the second quarter of fiscal year 2022. John Rim, CEO of Samsung Biologics, stated, “Samsung Biologics delivered another strong quarterly performance ahead of our guidance with our revenue exceeding KRW 1 trillion for the first half of the year. Operations are seamless across all our plants, and the partial completion of Plant 4 is just around the corner, scheduled to commence operations in October this year. We completed a deal to fully acquire Samsung Bioepis, expanding and diversifying our revenue base and business portfolio. More recently, we have officially signed an agreement to purchase land for Bio campus II. All these factors signal that we have a strong momentum going, and that we are well on track in our expansion plans to serve the increasing market demands.” SECOND QUARTER 2022 RESULTS Samsung Biologics demonstrated strong operational excellence and business agility in the second quarter with earnings exceeding initial projections. Reporting under the consolidated approach for the first time since the acquisition in April, Samsung Biologics and Samsung Bioepis in the second fiscal quarter recorded a revenue of KRW 651.4 billion, operating profit of KRW 169.7 billion, and net profit of KRW 152 billion with EBITDA margin of 39.7%. On a standalone basis, the second quarter 2022 revenue for Samsung Biologics was KRW 503.7 billion, an increase of 22.2% from KRW 412.2 billion reported for the second quarter in the previous year, due to efficiency in operations despite a scheduled slow-down of Plant 2, and attributable to the expansion of product sales. Samsung Biologics also reported an operating profit of KRW 171.9 billion, 3.18% higher than the prior-year period, and a net profit of KRW 101.8 billion with an operating profit margin of 34.1% for the same quarter. On a standalone basis, Samsung Bioepis earned KRW 232.8 billion in revenue, 24.2% higher than the prior-year period attributable to the increase in sales of its biosimilar products in global markets including the US and Europe. Samsung Bioepis’s operating profit increased significantly by 95.7% compared to the prior-year period, at KRW 58.5 billion. FISCAL YEAR 2022 OUTLOOK The construction of Samsung Biologics Plant 4 is on schedule with 6 X 10KL production capacity expected to commence operations in October. The company has secured a number of large scale manufacturing contracts with active presales activities for Plant 4, and at the close of Q2, in the first half of 2022 alone, the company had secured over USD 7.9 billion in sales backlog including deals with Janssen, Merck, GSK, Lilly, and Novartis to name a few. Earlier this month, Samsung Biologics secured additional land sized at 357,366 ㎡ and approximately 30% larger than its current site, to support the build out of its second campus. At the newly acquired site, the company will host additional large-scale manufacturing facilities as well as an open innovation facility. Samsung Biologics also published its second annual ESG Report this month, reflecting the company’s latest sustainability efforts to address a wide range of environmental, social, and governance (ESG) activities related to its business. The company aims to build an eco-friendly business environment and achieve net zero GHG emissions in its operations, and continue to enhance its social contribution activities that strive to support the health of its local communities. Samsung Bioepis has a total of six biosimilar products approved and commercially available in different markets , and its revenue has steadily grown driven by increases in global product sales and milestone payments. Of the six products, SB4, a biosimilar to Enbrel (etanercept), which was launched in Europe in 2016, has surpassed its originator’s sales in Europe by overtaking the majority of the market share, and the company recently launched SB11, a biosimilar to Lucentis (ranibizumab), in June 20
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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