Measure Twice, Treat Once: Navigating the regulatory landscape of assay development to ensure high-quality CGT products
Research and development of new cellular and gene therapy (CGT) products to treat different therapeutic indications is growing rapidly, and many candidates are progressing in clinical development.
CGTs must be manufactured using processes that ensure a predefined quality of products. Careful monitoring of critical quality attributes and other product characteristics is needed in process development and in manufacturing to ensure product safety and efficacy. Product intermediaries and drug products are assayed using analytical assays that must be validated before regulatory approval.
In this article from BioProcess International, the authors discuss the use of analytical assays in process development and manufacturing, how tests are developed and validated, and current gaps in the analytical tool kit.