Drug Substance Manufacturing

Safe, Efficient, High Quality, and Compliant

Our service offerings:

Clinical phase I, II, III pilot and commercial production of drug substances (including ADCs, RDCs, PDCs, AOCs, and other drug conjugates)

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Service scope:
Service advantages:
Service Advantages:
  •  · Facilities equipped with bioreactors scaling up to 500L adapt to various conjugation processes

     · Disposable materials and consumables are product specific, preventing cross-contamination

     · High-potency materials up to OEB 5 and photosensitive drug conjugates could be handled in GMP facilities

     · Efficient delivery: Capable of completing project production in 3-10 days on average

  •  · Over 10 years of production experience in conjugation, purification, drug substance preparation, and filling.

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Key Equipment:
  • OEB5 Negative pressure isolator
  • AKTA Process chromatography skids
  • TFF filter holder
  • Single-use reactors