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

gene therapies

Ever since the first gene therapy programs were initiated, WuXi AppTec has been providing the technical testing competencies and regulatory expertise to help navigate novel biologics from early-stage development through to late-stage clinical trials. We will work with you to develop comprehensive biosafety testing programs that meet the highest expectations of regulatory authorities worldwide.

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

  • GMP Cell Banking
  • Cell Line Characterization
  • Viral Bank Safety Testing and Characterization
  • Plasmid Stock Characterization
  • Replication-Competent Viral Vector Testing
  • Biodistribution
  • Lot Release
  • Product Stability
  • Raw Materials Testing and Supply Chain Assessment
  • Assay Development and Validation
  • Vector Purification Process Validation for Viral Clearance

Gene Therapy Experience

WuXi AppTec utilizes over 20 years of experience to guide you safely into clinical trials.

  • Expertise to provide biosafety programs for all types of viral gene therapy vectors (adenovirus, lentivirus, AAV, herpes, etc).
  • 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.

Program Features

  • Extensive knowledge and multiple assay methodologies for the testing of replication competent vectors.
  • Development of custom vector potency and identity assays for 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.
  • Ph.D.-level virologists with industry expertise to develop custom assays from novel vectors.
  • Access to industry-leading gene therapy consultants.

Learn more about our Gene Therapy Manufacturing services.