Product Quality in Focus

This webcast features: Tim Kelly, CEO, Oxford Biomedica Solutions.

It is now fully apparent that product quality is critical to the performance of gene therapy products. In turn, regulatory expectations have risen dramatically for the quality of the viral vectors that are used to deliver such therapies. That said, yields from viral-vector production processes tend to be much lower than those for conventional protein products. The ability to address all aspects of product quality while still achieving high vector output requires deep expertise, abundant experience, and a wide breadth of technical capabilities.

This presentation will highlight quality attributes that are particularly important for AAV gene therapy products and describe how Oxford Biomedica ensures that its platform capability has delivered gene therapy products that meet the highest quality standards.

Key Takeaways:

  1. Leveraging expertise and experience is the fastest and safest path forward for gene therapy manufacturing.
  2. Addressing the wide and varying technical and product-quality challenges of viral-vector manufacturing requires a full scope of capabilities and a comprehensive planning program.
  3. Learning what is critical from a product-quality perspective will help to determine the success of a gene therapy manufacturing program.

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