Cognate's Cobra teams can provide cell banking and viral seed stock production to support customers’ projects from all phases of clinical development and up to commercial-scale supply.
Working within cGMP manufacturing regulations, we can develop and maintain both Master & Working Cell Banks (MCB & WCB) and Viral Seed Stocks (VSS).
We also provide GMP cell bank storage and can support secondary site storage in the US, UK and the EU for added security, as requested.
Cobra has been manufacturing cGMP viral vector products for gene therapies and viral vaccines since 2002 and more recently a number of different immuno-oncology plasmid DNA and Viral-vector-based therapies, including two separate COVID vaccines in various stages of clinical and commercial development.
In close concert with our GMP manufacturing team, our testing for all viral manufacturing programs to ensure quality products for our customers’ preclinical and clinical trials through to commercial supply.
Processes are clearly defined, controlled and can be qualified to ensure compliance, clear records are made, and any deviations are investigated and documented. We are able to provide a certificate of GMP compliance and, if required, a GMP campaign summary report plus QA review of completed documentation.
All viral vector products undergo genetic stability testing and are assessed according to ICH guidelines for Drug Substance & Drug Product, and through forced degradation and pre-formulation studies.
As part of the Quality Assurance process, viral vector products are tested according to ICH guidelines for Drug Substance & Drug Product. These studies help to determine the effect of external factors on the active component within a customer’s product.
The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined. Forced degradation studies, to accelerate the natural degradation process, are also undertaken to determine the effect on the product.