U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

vaccines

No matter the type of vaccine – virus (live, attenuated, and inactivated), whole cell, peptide or recombinant protein – or how it is produced – in eggs, microbial or mammalian cell culture, or derived from plants – WuXi AppTec will develop a comprehensive biosafety testing plan that will meet regulatory scrutiny.

A full spectrum of services is available to speed vaccines from discovery to commercialization:

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

Vaccine Experience

  • Multiple cell-based potency and identity assays developed and validated for specific virus vaccines.
  • Hundreds of cell banks and viral banks characterized.
  • Thousands of clinical lots tested under GLP and GMP.
  • Over 50 cell lines and 60 viruses available as indicator cell lines or positive controls for potency, identity or biosafety assays.
  • Over 80 PCR assays developed for detection of specific adventitious or contaminating viruses.
  • Thousands of clinical samples assessed to detect viruses.

Program Features

  • Custom assay development for vector potency and identity for use in lot release or clinical trials.
  • Both in-house animal facilities and molecular biology laboratories available for biodistribution and toxicology studies.
  • Established protocols for GMP suite cleaning validations and environmental monitoring.
  • Testing plans and assays available to screen for adventitious agents from animal-derived raw materials or other raw material sources.
  • Development of tumorigenicity and oncogenicity assays to assess producer cell lines and virus stocks.
  • Ph.D.-level virologists with expertise to develop custom assays from novel vectors.
  • Access to industry-leading regulatory, quality or CMC vaccine consultants.