Microbial-Derived Protein Therapeutics

Download PDF

Download PDF

Download PDF

Download PDF

WuXi AppTec offers comprehensive GLP- and GMP-compliant testing programs for recombinant proteins derived from prokaryotic (microbial) 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 is a four-page brochure that contains an informative graphic with details about the various testing services, including:

  • In-Life & Toxicology Studies
  • Raw Materials Testing & Supply Chain Assessment
  • Product Analytical Characterization
  • Assay Development & Validation
  • Cell Line Characterization & Cell Line Storage
  • Detection of Process-Related Impurities
  • Lot Release Testing
  • Stability Studies

Program Features

  • Strong track record of supporting IND, BLA and market approvals by regulatory agencies worldwide.
  • Senior staff members serve on industry task forces to be involved with and remain current on regulatory policies.
  • Expert advice/consulting on U.S. and inter-national regulatory requirements.
  • Custom assay program available for unique microbial cell lines and products.
  • Dedicated project management team and on-line sample tracking and ordering.
  • Comprehensive quality systems that meet global regulatory acceptance.
  • Commitment to Continuous Improvement and LEAN initiatives to ensure consistency in meeting Sponsor's service expectations.