WuXi AppTec offers comprehensive GMP-compliant testing for protein therapeutics including recombinant proteins and monoclonal antibodies. U.S.-based services include IND-enabling GMP cell banking and cell line characterization programs and toxicology programs through to the development, validation and execution of GMP lot release and stability assays for clinical and commercial production lots.
- In-Life & Toxicology Studies
- Product / Reference Standard Characterization
- Raw Materials Testing & Supply Chain Assessment
- Assay Development & Validation
- GMP Cell Banking & Cell Line Characterization
- Detection of Process-Related Impurities
- Viral Clearance / Inactivation Studies
- Lot Release Testing
- Product Stability Studies
- Established, open-access technology platforms to expedite global regulatory submissions.
- Global access to the world’s largest and growing healthcare markets.
- Intimate knowledge of U.S., China and other worldwide regulatory environments, including product development and approval pathways.
- Strong track record of supporting IND, BLA and market approvals by regulatory agencies worldwide.
- Expert advice/consulting on U.S. and international regulatory requirements.
- Dedicated project management team and on-line sample tracking and ordering.
- Comprehensive quality systems to conduct GMP programs that meet global regulatory acceptance.
- Thousands of commercial product lots and raw material lots released under GMP guidelines or undergoing stability assessment.
- Over 3,000 custom viral clearance studies performed for IND, BLA, and market approvals.