Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
SPECIAL REPORT #22 (continuation)
Samsung Biologics; A World Leader in Biopharmaceutical Manufacturing
Sponsored by Samsung BioLogics
A few days after Celltrion Press Conference by Chairman Seo Jung-jin, Samsung Biologics has issued the following report.
Biopharmaceutical outsourcing for research and development is expected to exceed revenues of $43 billion USD by 2026, as a growing number of pharmaceutical companies turn to independent contract development and manufacturing organizations (CDMOs) to bring new products and technology to market more quickly and efficiently than ever before. In this rapidly expanding marketplace, outsourcing research, development, and product manufacturing to full-service CDMOs can allow these companies to access specialized expertise and sophisticated technologies to remain agile and competitive. With end-to-end services including research, development, manufacturing, and approvals from regulatory entities across the globe, Samsung BioLogics is uniquely positioned as a global leader in the biopharmaceutical manufacturing industry.
CMOs, CROs, and CDMOs: The evolution of an industry
The current trend toward building partnerships between pharmaceutical companies and outsourcing companies has its roots in the emergence of separate entities for handling the manufacturing aspect of product development. These contract manufacturing organizations (CMOs) were created to meet large-scale manufacturing needs for products that had already completed all development stages of the process. In the same vein, contract research organizations were designed to manage the research phases of development.
Today’s full-service CDMOs combine product development with aspects of research and manufacturing to provide “one-stop shopping” for client pharmaceutical companies. By partnering with a CDMO, pharmaceutical companies can concentrate their resources on their own core capabilities while leaving other aspects of a product development to the dedicated facilities of an independent organization—a move that offers an economical and efficient solution for getting products to the marketplace.
Samsung BioLogics: Uniquely positioned for the future
Since its launch in 2011, Samsung BioLogics has built itself into the world’s largest contract development and manufacturing organization. Since then, the South Korea-based company has evolved from a CMO to a full-featured CDMO with capabilities to support client needs at all stages of product development and production. As therapies become more complex and research demands become more intensive, clients in the pharmaceutical industry need innovative solutions that encompass advanced processes, highly specialized expertise and the ability to scale technology to meet constantly changing demands. Samsung BioLogics has the broad capabilities, resources and scheduling flexibility to support every aspect of the research and development process from preclinical to commercial manufacturing.
Multiple facilities provide flexibility, scalability, and quality
Samsung BioLogics has three state-of-the-art facilities with a total capacity of 362,000 liters, which makes it the largest company of its kind in the world. With the support of three megaplants, projects can scale easily to help clients with needs ranging from cell line development, quality control and stability studies to commercial manufacturing, as well as many other drug substance and drug product-related tasks throughout the process. In line with what Samsung BioLogics accomplished in the beginning to establish itself as a contract manufacturer, today’s expanded Samsung BioLogics has invested each of its new service areas with highly qualified staff and cutting-edge equipment; this investment will provide a shorter time to market while meeting the highest standards of excellence. These investments have also allowed Samsung BioLogics to expand into new service areas in order to meet the needs of new and established pharmaceutical clients.
Commitment to quality prioritizes client satisfaction
To get the development and support needed to bring quality products to market quickly and safely, biopharmaceutical companies typically have to work with multiple providers. But that creates challenges in areas including communication, coordinating facilities and projects, and managing multiple aspects of a project with different teams. Because its expanded organization encompasses all stages of product research, development and manufacture, Samsung BioLogics offers these companies a solution that can minimize these challenges or eliminate them altogether. With a fully realized end-to-end service model, Samsung BioLogics eliminates the need to coordinate among different companies in order to complete all stages of a project. Thanks to a flawless regulatory record, Samsung BioLogics has 24 approvals including drug product clearances from global regulatory bodies such as the FDA, EMA, and PMDA. With increasingly stringent regulatory oversight, a number of other companies have failed to receive these approvals; Samsung BioLogics, meanwhile, has received its approvals without a single critical observation. Samsung BioLogics is uniquely able to support the development and delivery of new drugs and other products at every stage of the process while meeting the evolving needs of pharmaceutical companies worldwide.
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