USP boosts support for AAV-based gene therapy manufacturers

**Title: USP Introduces New Resources to Aid AAV Gene Therapy Development**

The United States Pharmacopeia (USP) has released new resources aimed at supporting manufacturers of adeno-associated virus (AAV)-based gene therapies. These efforts coincide with the publication of the proposed General Chapter , which is designed to provide guidance for advancing AAV gene therapy production and development.

The initiative seeks to address challenges faced by manufacturers in producing high-quality AAV-based therapies, which are increasingly used in treating genetic disorders. The proposed General Chapter outlines standards and best practices for ensuring consistency, safety, and efficacy in AAV manufacturing processes. USP’s additional resources aim to complement these guidelines by offering tools and frameworks that facilitate compliance and innovation within the field.

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Source: https://www.europeanpharmaceuticalreview.com/news/254703/usp-boosts-support-for-aav-based-gene-therapy-manufacturers/

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後