Identity Testing by NGS as a Means of Risk Mitigation for Viral Gene Therapies

WEBINAR

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 than 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. In this webinar, we will discuss a risk-based testing strategy, in the context of identity, for viral vector manufacturing, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.

In this webinar, we'll 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