Gene Therapy: Meeting and Exceeding Regulatory Testing Requirements for AAV Vectors

Adeno-associated virus (AAV) vectors are valuable gene delivery tools for gene therapies. However, the use of AAV vectors requires comprehensive testing, of the drug substance and product, to ensure potency, stability, identity, and purity. Multiple safety assays are required in order to meet regulatory requirements, such as testing for replication-competent AAV. In addition, the testing requirements for gene therapies evolve as regulators, testing organizations, and drug developers apply recent learnings to guide future strategies. It can be advantageous to work with a testing organization that can provide a comprehensive service from the early stages of drug development through to clinical trials, supporting research, clinical, and commercial GMP material.

In this GEN webinar, our distinguished presenters, Dr. Heather Malicki and Dr. Andreas Solomos will discuss the regulatory requirements and challenges involved with bringing new AAV-based gene therapies to market. Additionally, we will learn about a unique AAV testing panel that supports customers through their therapeutic development journey, as well as the benefits of working with a single service for the manufacturing and testing process.

A live Q&A followed the presentation, offering a chance to pose questions to our expert panelists.