Consultants Submit Draft AAV Guidance to FDA

Dark Horse Consulting Group has submitted to FDA a proposed draft guidance, Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture. The company says the development of the draft guidance was led by former CBER CMC reviewer Donald Fink, who has joined Dark Horse as a regulatory practice expert, and Dark Horse consultant Christina Fuentes.

Dark Horse says the proposal aims to offer a benchmarking goal in making a recommendation to establish a release criterion for empty AAV vector capsid impurity. “If FDA moves forward with a guidance informed by this recommendation,” the consulting firm says, “the result will be a reasonable, achievable impurity limit that will maximize efficiency while minimizing adverse side effects. It is important to note that the guidance retains the option for a data-driven demonstration of acceptable patient safety when the benchmark goal cannot be achieved.”