Samsung Biologics

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Samsung Biologics is a South Korean biotechnology company specializing in biopharmaceutical manufacturing and development services. Founded in 2011 as a subsidiary of the Samsung Group, Samsung Biologics has rapidly grown to become one of the world's leading contract development and manufacturing organizations (CDMOs). The company's headquarters and manufacturing facilities are located in Incheon, South Korea, within the Songdo International Business District, a hub for the biotech industry.

Overview[edit | edit source]

Samsung Biologics provides a full range of services from cell line development, process development, and clinical trials material manufacturing to commercial-scale production and aseptic fill/finish. The company operates with the mission to enhance the accessibility of biopharmaceuticals globally by offering high-quality, efficient, and scalable manufacturing solutions.

Facilities[edit | edit source]

Samsung Biologics operates three state-of-the-art manufacturing facilities in South Korea, with a fourth under construction, making it one of the largest CDMOs in terms of production capacity. These facilities are equipped with cutting-edge technologies for the production of monoclonal antibodies (mAbs), fusion proteins, and other recombinant proteins. The company's facilities are designed to comply with international regulatory standards, including those set by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS).

Services[edit | edit source]

Samsung Biologics offers a wide range of services across the biopharmaceutical development and manufacturing spectrum, including:

  • Cell Line Development: Utilizing proprietary and third-party cell lines for the efficient production of high-quality biologics.
  • Process Development: Optimizing bioprocessing conditions to scale up production while ensuring product quality and consistency.
  • Clinical Trials Material Manufacturing: Producing small-scale batches for use in clinical trials.
  • Commercial Manufacturing: Offering large-scale production capabilities for global supply of approved biopharmaceutical products.
  • Aseptic Fill/Finish: Providing final formulation and packaging services in a sterile environment.

Partnerships and Collaborations[edit | edit source]

Samsung Biologics has established numerous partnerships and collaborations with global pharmaceutical and biotech companies to accelerate the development and manufacturing of biologics. These collaborations range from early-stage development projects to full-scale commercial manufacturing agreements, underscoring the company's role as a critical partner in the biopharmaceutical supply chain.

Sustainability and Corporate Social Responsibility[edit | edit source]

Samsung Biologics is committed to sustainability and corporate social responsibility (CSR) practices. The company focuses on reducing its environmental impact through energy-efficient operations, waste reduction, and sustainable resource management. Additionally, Samsung Biologics engages in various CSR activities, including community outreach and support for healthcare initiatives.

Future Directions[edit | edit source]

As the demand for biopharmaceuticals continues to grow, Samsung Biologics is expanding its capabilities and capacity to meet the needs of the global healthcare market. The company's ongoing investments in technology, infrastructure, and human resources aim to solidify its position as a leading CDMO in the biopharmaceutical industry.

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Contributors: Prab R. Tumpati, MD