Viral Clearance Studies

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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 and Cryopreservation
  • 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.