Lot Release Testing
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.