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# Improve Cell, Gene Manufacturing Guidance: ISCT
- URL: https://www.fdaweb.com/improve-cell-gene-manufacturing-guidance-isct/
- Published: 2023-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:15:25.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155737

The International Society for Cell & Gene Therapy (ISCT) says an FDA draft guidance on manufacturing changes and comparability for human cellular and gene therapy products “could benefit from more detailed information as it covers a very broad range of therapeutic products.” The ISCT comment [letter](ttps://downloads.regulations.gov/FDA-2023-D-2436-0019/attachment%5F1.pdf) says the analytical approach might be very different when dealing with some products that are precisely targeted and some that are more about general manipulation of a system.

“The more broadly acting categories may benefit from allowing a matrix of assays focused on the type of activity, the specific mechanisms being potentially less important whereas the more targeted products may require only one, or a relatively small number, to demonstrate consistent identity and potency,” the society says.

ISCT also submits line-by-line specific comments.