Samsung Biologics is a contract manufacturing organization that provides cGMP biologics manufacturing services from clinical to commercial scale — covering drug substance manufacturing, drug product, and aseptic fill-finish. With 845 kL of total capacity and 455+ regulatory approvals across FDA, EMA, and PMDA, it supports production of mAbs, bispecific antibodies, ADCs, recombinant proteins, and mRNAs.
Key Advantages of Samsung Biologics Manufacturing Services
Samsung Biologics offers industry-leading biologics manufacturing services, combining quality, capacity, and operational efficiency to support your development and commercialization goals.
Seamless CGMP Manufacturing & Fill-Finish
Samsung Biologics is a trusted partner for seamless CGMP manufacturing services, including tech transfers, clinical and commercial biologics manufacturing, and aseptic fill-finish. In a rapidly evolving biopharmaceutical landscape, identifying a partner that can adapt to the unique needs of each portfolio is essential for success. Samsung Biologics is committed to supporting clients with a wide range of benefits, including unparalleled quality, scalable capacity, process agility, partnership flexibility, operational efficiency, industry-leading sustainability, and continuous innovation.
Samsung Biologics Manufacturing Summary
- Samsung Biologics provides cGMP biologics manufacturing services for clinical and commercial supply, including drug substance and aseptic fill-finish.
- Total biomanufacturing capacity is 845 kL across BIO Campus I (605 kL), Plant 5 (180 kL), and Rockville, Maryland (60 kL).
- Samsung Biologics holds 455+ regulatory approvals across FDA, EMA, and PMDA, recognized by CDMO Leadership Awards for 12 consecutive years.
- Supported modalities include monoclonal antibodies, bispecific antibodies, ADCs, recombinant proteins, mRNAs, and Fc fusion proteins.
Samsung Biologics offers advanced CGMP facilities, providing safe and reliable clinical and commercial biologics. All processes are CGMP-compliant and meet the standards defined by regulatory authorities.
Dedicated Project Management for Complex Molecules
Our dedicated project management team supports every stage of biopharma manufacturing, guiding production of complex modalities - mAbs, bsAbs/multispecifics, ADCs, recombinant proteins, mRNAs, and Fc fusion proteins - with precision and regulatory alignment.
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Drug Substance Manufacturing
- Leveraging economies of scale and fast turnaround, our drug substance manufacturing ensures consistent, high-quality biologics at both clinical and commercial scales.
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Drug Product & Aseptic Fill-Finish Services
- Our drug product manufacturing includes aseptic fill-finish services designed to ensure patient safety, product integrity, and regulatory compliance across clinical and commercial stages.
Why Choose Samsung Biologics as Your CDMO Partner
Powered by digitalization and AI, we continuously expand capacity and innovate to meet advanced biologics needs. Partner with Samsung Biologics for reliable CDMO services that scale with your next-generation molecules.
- Total capacity
- 845 kL
-
BIO Campus I
605 kL
+
-
Plant 5
180 kL
+
-
U.S. Facility (Rockville, MD)
60 kL
BIO Campus I
- Total Capacity
- 605,000 L
- Plant 1
- 30,000 L
- Plant 2
- 155,000 L
- Plant 3
- 180,000 L
- Plant 4
- 240,000 L
- Plant 5
- 180,000 L
- Plant 6-8
- 540,000 L*
*Total capacity by 2032
BIO Campus II
- Plant 5-8
- 720,000 L*
*Total capacity by 2032
-
-
Consecutive years
to be recognized by the
CDMO Leadership Awards
-
- 0
-
Regulatory approvals
(FDA, EMA, PMDA, etc.)
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