SERACH RESULTS FOR" Development "
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 firstname.lastname@example.org 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 / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes.Analytical Testing CapabilitiesAcross the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release, and stability.Our QC team is capable of performing analytical test method transfers from client laboratories, method validation, qualification, and verification in accordance to ICH Q2 (R1) guidelines, FDA, EMA, and PMDA requirements.Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of:Chemical Testing1. Impurity / Purity by HPLC2. Identification by FT-IR3. Water content4. Osmolality, Protein Content (A280), Appearance, pHBiochemical Testing1. Polymerase Chain Reaction (PCR)2. Enzyme-Linked Immunosorbent Assay (ELISA)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based AssaysMicrobiological Testing1. Sterility2. Microbial Limit (Bioburden)3. Microbial Identification4. EndotoxinStability Program CapabilitiesWe maintain controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and accelerated conditions (with temperature and/or light).Environmental and Clean Utility MonitoringThrough our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that our controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable air particles and surfaces. Clean Utilities Monitoring includes the testing of water, compress gases, and clean steam for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
development stage to DS products for lot release tests of Mycoplasma & Virus detection. Our service is expanding to Cell bank manufacturing, Cell line characterization and Viral clearance study. Overview imageSamsung Biologics CRO?Lot Release TestingMycoplasma & Virus detection, Sterility, Endotoxinand Bioburden testingCell Line CharacterizationIdentity (NGS), In vitro / In vivo virus screen,Adventitious, Retrovirus and mycoplasma testingCell Bank ManufacturingMCB / WCB / EOPC manufacturing andcell storage servicesViral ClearanceVirus inactivation and removal study (GLP)
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 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.※ Download Application Form Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
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. Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
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
Development Procurement, Roche (2014-2018)VP, CFO Global Product Development, Roche (2010-2013) Senior Vice President & Managing DirectorDong Joong Kim Senior Vice President & Managing Director, Business Resources Innovation Center, Samsung Biologics (2014-Present)Head of Planning Support Team, Production Technology Institute, Samsung Electronics(2013-2014) Independent directorSeok Woo Jeong Independent Director, Samsung Biologics (2016-Present)Professor, Department of Business Administration, Korea University Business School (1997-Present)Non-standing Member, Korea Accounting Institute (2016-2019) Independent directorSoon Jo Kwon Independent Director, Samsung Biologics(2016-Present)Professor, Department of BioLogical Engineering, Inha University(2013-Present)Chairman, International Cooperation Committee, Institute of Biological Engineering (IBE)(2011-2013) Independent DirectorKun Nyoung Huh Independent Director, Samsung Biologics(2019-Present)Advisor, Pyeong An Lawfirm(2019-Present)Presiding Judge, Seoul Central District Court (2004-2007) Independent Director Eunice Kyunghee Kim Watch the Interview Independent Director, Samsung Biologics (2020-Present)Professor at Law School of Ewha Women's University (2010-Present)Vice president of International Association of Korean Lawyers (IAKL) (2008-Present)Compliance officer of executive vice president & Head of Legal Affairs at Hana Financial Group, Inc. (2008-2010) Appointment of DirectorsMembers of the board of directors are elected through a resolution of the general meeting of shareholders under the company’s articles of incorporation. Incumbent members may be reelected after the expiration of their terms. Samsung Biologics shall have at least three but no more than ten directors and such directors shall be appointed at the general meeting of shareholders; provided, however, that at least three independent directors shall be appointed and the number of the independent directors shall account for at last a majority of the total number of directors.A resolution for the election of directors shall be adopted by the affirmative votes of a majority of the shareholders present at the meeting, which shall also be at least 1/4 of the total number of issued and outstanding shares.Any vacancy in the office of directors shall be filled at a general meeting of shareholders; provided, however, that if the number of directors does not fall below the number prescribed in Paragraph 1 of Article 29 in the Articles of Incorporation and there is no difficulty in the administration of business, the foregoing shall not be applicable. Term of Office of DirectorThe term of office of directors shall end at the close of the ordinary general meeting of shareholders convened in respect to the last fiscal year within three years from their appointment. ChairpersonThe chairperson of the board of directors shall be appointed among the directors by a resolution of the board of directors. Resolution of the BODThe resolution of the board of directors shall be adopted in the attendance of a majority of the directors in the office and by the affirmative votes of a majority of the directors present at the meeting; provided, however, that a resolution of the board of directors on matters stipulated under Article 397-2 (Prohibition of Use of Corporate Opportunities and Assets) and Article 398 (Self-Dealing between Directors, etc. and the Company) of the Commercial Code shall be adopted by the affirmative votes of at least 2/3 of the directors in office. Independence of Independent DirectorsThe Independent Director Candidate Nomination Committee shall nominate the candidates for the independent directors among persons who meet qualification requirements stipulated in the relevant laws and regulations, including the Commercial Code, etc. An independent director shall be one with professional knowledge or sufficient experience in management, e
development relating to pharmaceutical products, subcontracting, advisory service;6.Education service and business service;7.Research service and investment business;8.Bioengineering and bio-pharmaceutical product research;9.Health and medical research;10.Joint research with domestic or international institutions;11.Technical research service for other domestic or international institutions;12.Plant design, purchasing agency, manufacture, construction, validation and supervision service;13.Real estate sale and purchase and leasing business;14.Transportation business;15.Parking lot business;16.Warehousing business;17.Businesses related to, necessary for, or incidental to any of the foregoing. Article 3 (Location of Head Office and Establishment of Branch, etc.) The Company shall have its head office in Incheon City and, if necessary, may establish branches, representative offices, business offices, sales offices, or local subsidiaries by a resolution of the Board of Directors (BOD) or of such a committee as authorized by the BOD. Article 4 (Method of Public Notices) The Company’s public notices shall be published in the Company’s website (http://samsungbiologics.com); provided, however, that in the event the public notices cannot be posted electronically due to computer system error or other unavoidable circumstances, the public notices shall be published in the JoongAng Ilbo, a daily newspaper of general circulation published in Seoul. Chapter 2.Shares Article 5 (Total Number of Shares Authorized to be Issued) The total number of shares that the Company is authorized to issue shall be Five Hundred Million (500,000,000) shares. Article 6 (Par Value per Share) The par value of each share to be issued by the Company shall be Two Thousand Five Hundred (2,500) won. Article 7 (Total Number of Shares to be Issued upon Incorporation) The total number of shares to be issued at the time of incorporation of the Company shall be One Million Five Hundred Thousand (1,500,000) shares. Article 8 (Classes of Shares and Share Certificates) ①The classes of shares to be issued by the Company shall be common shares and preferred shares, each of which shall be in registered form.②Preferred shares to be issued by the Company shall be preferred shares concerning dividends with non-voting rights, and the number of the preferred shares shall not be more than Fifty Million (50,000,000) shares.③Dividends on the preferred shares shall be first paid in cash at such dividend rate as determined by the BOD or such a committee as authorized by the BOD at the time of issuance based on the par value of the preferred shares.④In the event that the dividend rate of the common shares exceeds that of the preferred shares under Paragraph 3, any excess amount available for distribution after payment of dividends on the preferred shares and the common shares at the same ividend rate as that for the preferred shares shall be equally distributed to both common and preferred shareholders in proportion to their shareholding.⑤In the event that preferred dividends are not fully distributed on the preferred shares for any given fiscal year, any accumulated undistributed dividends shall be preferentially distributed first at the time of distribution of dividends in the immediately following fiscal year.⑥In case of rights issues, bonus issues or stock dividends, common shareholders shall be entitled to common shares, and preferred shareholders shall be entitled to preferred shares, in proportion to their respective shareholding; provided, however, that in case of rights issues, bonus issues or stock dividends, the Company may, if necessary, issue only one class of shares, where all the shareholders shall be entitled to such class of shares to be issued. Article 8-2(Electronic Registration of Rights to be Indicated on Shares and Stock Warrant Certificates) The Company shall electronically register rights to be indicated on shares and stock warrant certificates i
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 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. Annual Operation Embedding BCMS is the ongoing cycle of activities of the business continuity management program, which builds organizational resilience, and is the professional practice that defines how to integrate business continuity awareness and practice into business as usual activities. Embedding BCMS Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Performing Risk and Threat Mitigation Measures Implementation - Implements the solutions agreed in the designed stage · Development of Tactical/Operational Business Continuity Strategy· Establishment of Business Continuity Plans & a response structure Validation - Confirms that the business continuity program meets the objectives set in the policy and the plans and procedures in place are effective. · Exercise Program: performing annual exercises with various types of scenario by each department as well as company-wide· Management Review to ensure it aligns with organizational objectives Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Pe
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 gratitude for your consistent interest and trust in Samsung Biologics, and greatly appreciate your continued faith and encouragement to support the perpetual growth and sustainable development of all of our businesses. As always, thank you for your support. Sincerely, John Rim President & CEO, Samsung Biologics
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
development capabilities and future performance in novel drug development, and the deal will further deliver Samsung Bioepis' sales growth and operating margin improvements with streamlined operational efficiencies, budget surplus, and cash flow generation. We will continue to be in close communication with Biogen to work collaboratively for our future growth together. For the purchase of Bioepsis shares and to fund the company's strategic growth plans, we have decided to raise the capital of KRW 3 trillion by issuing new shares. By expanding our portfolio, we will evolve to become a global biopharmaceutical company as the next growth engine with great responsibilities to better serve our clients, shareholders, and ultimately society. Our company continues to hold the world's largest biomanufacturing 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
Development Strategy Youlim Kim Lead Scientist, Cell Line Development Technological advances in drug 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)
Development and 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.
Subscribe to our newsletter to download.
*If you have already subscribed, enter your email.
Please fill in your details, select one or more areas of interest, and click the subscribe button to receive our newsletter.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.
Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Target Anticancer Drugmore
-Naming Biopharmaceutical Products 1 Monoclonal Antibody Drugsmore
-Naming Biopharmaceutical Products 1 Monoclonal Antibody Drugsmore
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Target Agreement for Novel Targetmore
-Samsung Biologics and STCube Enter into Development and Manufacturing Agreement for Novel Targetmore