Regulatory considerations for analytical method development in gene therapy

Gene therapy is one of the fastest-moving sectors in the pharmaceutical industry, so the use of analytical methods, to ensure the safety and potency of therapeutics, is paramount.

Strengthen gene therapy development with advanced analytical method strategies

What This Report Reveals

The vital role of analytical methods in developing effective gene therapies.
Key analytical assay types, including characterization, in-process, and release methods.
How ICH Q14 and ICH Q2(R2) guide risk-based analytical method development.
Ways to reduce regulatory risk through early collaboration with FDA experts.

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