Mammalian-Derived Protein Therapeutics

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WuXi AppTec offers GLP- and GMP-compliant testing programs for recombinant proteins and monoclonal antibodies derived from mammalian cell culture production systems. Services include IND-enabling cell line and product/reference standard characterization and toxicology programs through to the development, validation and execution of GMP lot release and stability assays for clinical and commercial production lots.

The PDF available for download at right contains an informative graphic with details about our comprehensive services for mammalian-derived therapeutics - from discovery to commercialization - including these critical areas:

  • In-Life & Toxicology Studies
  • Raw Materials Testing & Supply Chain Assessment
  • Product / Reference Standard Characterization
  • Assay Development & Validation
  • Cell Line Characterization & GMP Cell Banking
  • Detection of Process-Related Impurities
  • Viral Clearance / Inactivation Studies
  • Lot Release Testing
  • Product Stability Studies

Experience

  • Thousands of commercial product lots or raw material lots released under GMP guidelines.
  • Over 2000 custom viral clearance studies performed for IND, BLA, and market approvals.
  • 70-80 cell banks manufactured or characterized each year.
  • Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination.
  • Over 40 product stability programs conducted annually.
  • Rapid response to and custom assays developed for new threats or specific environmental isolates of concern.
  • Performance and writing of risk assessments for raw materials and process step control programs.

Program Features

  • Senior staff members serve on industry task forces to be involved with and remain current on regulatory policies.
  • Access to industry-leading regulatory, quality and CMC consultants.
  • Custom assay program available for unique products.
  • Dedicated project management team and on-line sample tracking and ordering.
  • Comprehensive quality systems that meet global regulatory acceptance.
  • Dedicated microbiology, virology, molecular biology, cell biology, and analytical labs.
  • Extensive in-life facilities in both the U.S. and China.
  • Commitment to Continuous Improvement and LEAN initiatives to ensure consistency in meeting Sponsor's service expectations.