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Overview

SAMSUNG BIOLOGICS Office Photo

Samsung BioLogics was established in April 2011, and is headquartered in Incheon, South Korea. As a joint venture between Samsung affiliate companies and Quintiles Transnational Corp., Samsung BioLogics aims to become a global leader in the biopharmaceutical manufacturing industry.

Samsung has a long, rich history of research and development work. Our biologics business builds on principles of our past achievements and brings our technological leadership to the biologics sector. With Samsung’s quality, technology and innovation, Samsung BioLogics will establish a new global standard for best practices within biopharmaceutical manufacturing and transform global healthcare as we know it.

We are committed to excellence in the development and manufacturing of bio-healthcare products. Our client-oriented business model encourages high-standard, fast-turnaround contract manufacturing partnerships. Furthermore, our state-of-the-art advanced facilities are fully compliant with global healthcare regulations and Current Good Manufacturing Practice (cGMP) standards. To better serve the patients of our partners, we provide the proper infrastructure to develop, refine, and distribute biopharmaceutical products worldwide.

BUSINESS PORTFOLIO

Our Expertise

Samsung BioLogics provides high-quality manufacturing services for mammalian bulk manufacturing through full fill and finish.
Our management and staff offer outstanding manufacturing and quality assurance for clinical and commercial products.

  • A One Stop Provider
    From process development to bulk production and aseptic fill and finish, Samsung BioLogics is a one-stop provider for clients who need total biologics manufacturing. We offer services from pre-clinical quantities all the way through commercial production to best meet our clients’ needs.
  • Unmatched Workforce
    Samsung’s success is determined by our people. They are our foundation, our future, and give us our competitive edge.
    Samsung BioLogics’ teams consist of dedicated and seasoned professionals with outstanding academic qualifications, industry experience, exceptional work ethics, and unparalleled dedication. Our teams work closely with each client to ensure their individual goals are met.
  • A First-Class Facility
    Our facilities are custom designed for mammalian-cell therapeutic monoclonal antibody production with maximum flexibility.
    • Sophisticated clean room operations, industry-leading flexible design, and quick changeover
    • High titer production capability
    • Integrated drug substance & drug product manufacturing in one facility
  • Excellent Quality Systems
    Our independent Quality Assurance and Quality Control Departments employ a systematic and scientific approach for risk management to ensure compliance with all global regulatory requirements. Our teams work closely with internal and external customer project teams to ensure product and employee safety, as well as full regulatory compliance. It is our ultimate responsibility to provide our customers with high quality products that meet the highest safety standards.

Certification

Certification items include division, Plant 1, Plant 2 and so on.
Plant 1 Plant 2
FDA 6 2
EUROPEAN MEDICINES AGENCY 5 2
PMDA 2 -