# Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/manufacturing-changes-and-comparability-for-human-cellular-and-gene-therapy-products/b4919edd-67a6-490a-ab51-aa1a3c93944e

> FDA guidance document: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products. Issue date: July 13, 2023. Get complete insights and analysis.

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## Details

- Title: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2023-07-13
- Comment Close Date: 2023-11-13
- Last Changed: 2023-08-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-2436">FDA-2023-D-2436</a>

## Related Documents

- [Potency Assurance for Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/potency-assurance-for-cellular-and-gene-therapy-products/2a9b0d81-9dd5-43cf-994c-ac0df102c216)
- [Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products/18812f43-d054-46e4-b040-2e02c42fb4a3)
- [Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products](https://www.globalkeysolutions.net/guidances/guidance-document/safety-testing-of-human-allogeneic-cells-expanded-for-use-in-cell-based-medical-products/6a8e9f02-c6de-403a-9762-daffba371531)