FDA comparability guidance: The impact of cell and gene therapy products

By , , and 2025-07-11T10:26:00

FDAMANU licensed

Abstract

This article compares the 2023 US Food and Drug Administration (FDA) draft guidance on ‘Manufacturing Changes and Comparability of Human Cellular and Gene Therapy Products’ against several FDA guidance documents on the comparability of biologics.

It aims to highlight several significant concerns that have resulted from the complex and unique nature of cell and gene therapy products and their manufacturing processes. 

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