By Mark Haydock, biologics CMC consultant, Agile Biologics Consulting LLC
Published in: Cell and Gene Newsletter, Nov 29, 2023
Published on: November 29, 2023
Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency. This requires confirming the vector’s identity, titer, purity, and safety using a variety of analytical methods.