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
- 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
- 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.
- 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.