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
- 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.
- 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.