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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 Biologics Executive Com
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
Research and 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 c
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 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 inc
research on the harmful factors of musculoskeletal disorders and deliver a program for the prevention of musculoskeletal disorders to achieve a better working environment. Operation of Mental Health ClinicWe operate a variety of programs for mental health to prevent any mental health issues and mental health related accidents occurring for our valued employees. Industrial Hygiene Management Work Environment AssessmentWe continue to make the essential efforts to create healthy workplaces by measuring the exposure levels of harmful factors in the work environment in order to prevent any health problems and create a safe and pleasant working environment. Chemical Risk AssessmentWe assess the hazards of handling chemical substances and establish the relevant safety management measures to ensure that all our employees remain “chemically safe.” Hands-on Safety TrainingWe run hands-on training programs to enhance the safety and emergency response capabilities of all our employees.
research and consulting firm Roots Analysis, the global bispecific antibody market is expected to grow at an annual rate of 34% to top $9 billion by 2030. The market is considered a blue ocean, with only two bispecific antibodies approved by both the FDA and European Medicine Agency for the treatment of cancer patients. Attractive treatment modality Bispecific antibodies are capable of targeting two distinct antigens simultaneously, improving treatment potential compared to the conventional monoclonal antibodies that only target one type of antigen. Many complex diseases are driven by a variety of factors, which can circumvent the impact of a drug. Bispecific antibodies can improve the specificity and effectiveness, such as in the case of cancer immunotherapy. One arm binds to an antigen on a cancer cell, while the other binds to T-cells, bringing both cell types together to activate T-cells to eliminate the cancer cells. However, there have been challenges in development of bispecific antibodies, especially regarding immunogenicity and chain mispairing, while issues in respect to the quality and stability have hampered their wider clinical application. S-DUALTM boasts safety and optimal manufacturabilitySamsung Biologics launched a new proprietary development technology platform, S-DUAL™ in September, boosting its strength in the CDO service. Having a unique asymmetric design, S-DUAL™ has high purity, yield and productivity. In the production of bispecific antibodies, only one of eight possible combinations is bispecific – requiring advanced technology to differentiate it. With a unique asymmetric design, S-DUAL™ can effectively separate and analyze the bispecific antibody as impurities from the improper pairings form different sizes. It also applies ‘knob-in-hole’ technique to avoid mispairing between two heavy chains and light chains. This strategy provides high yield and maximum purity of 99%. S-DUAL™ also has low immunogenicity due to human immunoglobulin gamma (lgG)-like structure. Samsung Biologics can design tailored antibody structures depending on clients’ needs. Biopharma’s new drug development partnerAs Samsung Biologics provides end-to-end services, from contract development to contract manufacturing, it has a competitive edge in new drug development, where speed is crucial. Samsung Biologics has received over 160 regulatory approvals as of October 2022. The company has also strengthened its foothold as a new drug development partner by establishing a one-stop service from cell line development to commercial manufacturing, and opened an CDO R&D Center in San Francisco to provide services in close proximity to clients. To meet fast-changing industry trends, Samsung also launched DEVELOPICK™, a developability assessment platform that screens molecules at an early stage to identify candidates with the best potential for advancement to Investigational New Drug, alongside the S-DUAL™. Samsung Biologics will continue to invest and take action to lead in the next-generation of biopharmaceuticals. Related ContentWhitepapers Fundamental Considerations for Bispecific Antibody-based Cell Line DevelopmentSamsung BIO Insight BioProcess International 2022 | Samsung Biologics unveils new development platforms to offer differentiated services
research and consulting firm Roots Analysis, the global bispecific antibody market is expected to grow at an annual rate of 34% to reach 9.6 billion USD by 2030. DEVELOPICK™ is a rapid developability assessment platform that systematically screens molecules at an early stage to identify candidates with the best potential for advancement to Investigational New Drug. The assessment platform enables clients to conduct a robust risk assessment for unsorted drug candidates within a month. By utilizing DEVELOPICK™, Samsung Biologics can provide early insight and selection guidance to save time and cost, and ultimately maximize efficiency. Promoting Strengths of Differentiated CDO Services and Bolstering Networking On September 30, Wonjun Yang, Lead Scientist for Antibody-Based Research at Samsung Biologics, shared his insights and new approaches in bispecific antibody development. Samsung Biologics also held a total of four poster sessions to promote DEVELOPICK™ and its MSAT (Manufacturing Science and Technology) capabilities during the three-day event to showcase the company’s competency in the contract development business. Solidifying Global Foothold as a Partner for Successful Development of New Drugs Samsung Biologics has won over 100 projects since it first launched its CDO business in 2018. It offers end-to-end, one-stop services, from cell line development to integrated manufacturing from clinical to commercial, enabling cost and time reduction for development. Samsung Biologics continues to strengthen its foothold in the global contract development market, by opening an R&D Center in San Francisco in 2020, launching its proprietary cell line, S-CHOice® in 2021, and the ‘S-DUALTM’ and ‘DEVELOPICKTM’ this year. Samsung Biologics will continue innovating for the successful development of new drugs and the production of high-quality biopharmaceuticals for clients. Related Contents Press Release Samsung Biologics introduces new development platforms S-DUAL™ and DEVELOPICK™ at BPI Boston 2022 Samsung BIO Insight The Value of Reducing Your Drug Development TimelineSamsung BIO Insight The Journey to Your Success | Explore Samsung Biologics' CDO Strengths
As one of the most critical steps in biomanufacturing, the drug product process requires scrupulous control and maintenance, attention to quality and extensive expertise for a successful clinical or commercial launch. Companies that do not have a reliable process in place could face challenges, costing time and money. At Samsung Biologics, we employ state-of-the-art technologies to make and deliver flawless drug products to our clients. Below is an in-depth look at how we manufacture these products at our headquarters in Songdo, South Korea. What is a Drug Product? Biomedicine is categorized into two elements: Drug Substance (DS) and Drug Product (DP). Drug substance, an ingredient used for producing DPs, is a material generated via either synthesis, fermentation or extraction, or a combination of these three methods. For instance, extracted antibodies through cell culture and purification processes are considered drug substances. These substances then get transformed into a dosage form called drug product — which, after being aseptically filled into either a vial, cartridge or syringe, gets safely injected into a patient’s body. How is a Drug Product Manufactured? Samsung Biologics manufactures drug products by using drug substances manufactured at its own site or delivered from clients. Drug Product Manufacturing Stages > Formulation: First, scientists will integrate the characterization of client molecule with the final product format, developing a formulation that will ensure the delivery of a stable product. Depending on characteristics of substances, buffers are utilized in this stage to maintain safety.> Aseptic Filling: Once formulated, substances – in either a liquid or lyophilized form – get filled into a container such as a vial, pre-filled syringe or cartridge. If needed, a filling conducted in a lyophilized form adds maximum stability to biomedicines as lyophilization eliminates any remaining liquid or moisture inside the container.> Inspection: After being filled, biomedicines undergo a series of inspections to confirm they meet compliance and thus are safe for bodily injection.> Labeling and Packaging: And finally, drug products get labeled and packaged for shipment. Client-Optimized, End-to-End Solution Samsung Biologics provides a one-stop, end-to-end solution that consists of aseptic filling, visual inspection, labeling and packaging, release testing and regulatory support. To ensure flawless quality of drug products manufactured and delivered to clients across continents, Samsung Biologics may utilize stainless steel or a single-use system not only to accommodate distinctive manufacturing preferences from clients but also to ensure the quality of the drug product. Samsung Biologics’ Fill-Finish manufacturing capabilities The company has for years managed to meet the needs of its biopharma clients, both big and small, as it not only operates batches sized from 5L to 2,500L but also employs a small-scale clinical Flexible Filling Line (FFL). With the world’s largest CMO capacity, Samsung Biologics’ fully integrated drug substance and drug product manufacturing can help clients save operational time and cost. Additionally, the company employs a dedicated, expert MSAT team to efficiently execute optimization of process technology from the tech transfer stage. Furthermore, a thorough maintenance at the manufacturing stage is conducted to produce high-quality biomedicines as well as regulatory support in the subsequent stages for the sake of clients. Drug products must be rigorously inspected for their safety and effectiveness as they get directly injected into patients. Samsung Biologics has earned more than 63 drug product manufacturing approvals from global regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicine Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency. Preparing for a Healthier Future with Samsung Biologics Drug substances an
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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