Viral Vector Production Laboratory
The Viral Vector Production Laboratory provides large-scale good manufacturing practice production of viral products.
The Viral Vector Production Laboratory has the facilities and expertise needed for large-scale manufacturing, good manufacturing practice production and characterization of the viral product.
The Viral Vector Production Laboratory:
- Develops and applies viral vector manufacturing processes for new viral vector products to significantly increase the scale of virus production and purity of the viral product
- Develops appropriate quality-control assays to characterize the viral product
- Uses the developed manufacturing process and quality-control assays to produce and characterize large-scale viral vector preparations for advanced efficacy, toxicology and pharmacology studies
- Operates and maintains a good manufacturing practice production facility
- Converts viral vector manufacturing processes to conform to good manufacturing practices
- Provides production and storage of master cell banks, master virus banks and final clinical viral products using good manufacturing practices
- Coordinates all clinical product safety testing required before products are released to the clinic
- Obtains, prepares and archives all required good manufacturing practice documentation related to the product manufacturing process, product safety testing, facility testing and personnel training
- Provides all appropriate descriptions of the manufacturing process, product safety testing, and facility design and operation — and participates in all formal reviews of this information — needed to obtain approvals from all internal and external governing and regulatory bodies