The US Pharmacopeia (USP) has launched new resources aimed at supporting developers and manufacturers of AAV-based gene therapies.

This initiative seeks to standardize quality assessment and control throughout the production lifecycle of AAV therapies, ultimately expediting their development and commercialization.

A key component of this effort is the proposed General Chapter <1067>, which outlines best practices for the manufacture and quality control of recombinant Adeno-Associated Virus (rAAV) gene therapy products.

USP's resources include a comprehensive guide detailing quality and safety standards, along with common analytical methods tailored for AAV developers.

The initiative was developed in response to feedback from AAV manufacturers who highlighted the unique challenges they encounter in the regulatory and technical landscape.

In a related development, three pharmaceutical organizations formed a partnership in 2024 to enhance AAV gene therapy manufacturing processes and reduce costs for healthcare systems.

This partnership specifically focuses on improving perfusion processes to significantly increase the production volume of AAV therapies.