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[ed note, 5/17/2022: The opportunity to offer proposed draft guidance is open to anyone. We at DHC utilized a public platform of our own accord, not at the request of the FDA. Find further details in the first Q/A here. If you wish to reach out to us with comments or questions regarding this guidance, please write directly to firstname.lastname@example.org]
Walnut Creek, CA—Dark Horse Consulting Group (DHC), the market-leading global consultancy specializing exclusively in cell and gene therapies, has today submitted their proposed draft guidance on Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture to the United States Food and Drug administration via the agency’s online submission platform.
This effort was spearheaded by Donald Fink, Ph.D. (FDA expert and DHC Master Practice Expert, Regulatory) and Christina Fuentes, Ph.D. (DHC Consultant). During this work, they collaborated with several gene therapy experts, including Nicole K. Paulk, Ph.D., AAV Gene Therapy Professor at UCSF.
Dark Horse CEO Anthony Davies lauded the opportunity, saying, “The FDA’s willingness to entertain draft guidance recommendations has been an underutilized opportunity to assist in furthering the guidance necessary for advancing this field. While discussing our collective response to last fall’s AdComm around high-dose AAV toxicity, we recognized that our expertise could be invaluable in moving this discussion forward.”
The proposed draft guidance, which can be found in its entirety here, aims to offer a benchmarking goal in making a recommendation to establish a release criterion for empty AAV vector capsid impurity. If the FDA moves forward with guidance informed by this recommendation, the result will be a reasonable, achievable impurity limit that will maximize efficacy while minimizing adverse side effects. It is also important to note that DHC’s guidance retains the option for a data-driven demonstration of acceptable patient safety when the benchmark goal cannot be achieved.
To quote Dr. Fink, “Because we’ve worked with hundreds of C> clients, our Dark Horse consulting team has a unique vantage point from which to view the development process. This gives us a sense of what sort of guidance is needed to provide adequate guiderails.”
About Dark Horse Consulting Group
Dark Horse Consulting—a global company with offices in both California and London—specializes in the development of Cell and Gene Therapy products. DHC’s collective knowledge spans manufacturing support, process development and comparability, analytical development, quantitative modeling, quality systems, device development, regulatory support, project and program management, market research, and financing and diligence. Dark Horse offers an unmatched understanding of the challenges faced by cell and gene therapy developers and is able to apply best practices from this and other industries to address a diverse range of client needs.