Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

WuXi Biologics’ lot release program offers a high-quality comprehensive selection of assays and methodologies for determination of product potency, purity, identity, concentration/titer and biosafety (GLP or GMP).  WuXi’s in-house QC lot release program covers all stages of product manufacturing including:

  • Unprocessed Bulk Product / Cell Harvest Material
  • Purified Bulk Product (Drug Substance)
  • Final Drug Product

Client developed lot release assays could be tranferred to WuXi and verified, further developed/optimized and validated or WuXi’s large analytical and biosafety teams could develop and validate the appropriate tests to meet worldwide regulatory scrutiny.

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