Identity Testing By NGS As A Means Of Risk Mitigation For Viral Gene Therapies

Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.

The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approach

In this presentation we explore:

• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy

Speaker Bio:
Bradley Hasson is the Director of Lab Operations for Next Generation Sequencing Services.  Brad leads a team of Scientists, laboratory technicians, and bioinformaticians that perform NGS-based biosafety testing services in support of product characterization and release worldwide.  He has 15 years of experience developing and implementing molecular-based methods for the purposes of lot release and characterization testing in a variety of biologically derived products.