Challenges in Analytical Development and Testing for Gene Therapies

Given the rapid emergence of gene therapies based on recombinant adeno-associated virus (rAAV), there is a great need for appropriate analytical tools to support every lifecycle stage of these products.

Note that in this article “rAAV” refers to generic therapeutic constructs involving recombinant adeno-associated virus, regardless of serotype.

The FDA’s 2004 Process Analytic Technology (PAT) guidance outlined the agency’s vision for analytics as key indicators of product quality and safety. PAT emphasized the importance of in-process monitoring, thus exceeding the standard at the time of relying mostly on end-product testing.

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