Conduct Early-Phase Studies to Improve Manufacturability and Mitigate Risk

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Creating effective, scalable manufacturing strategies for adeno-associated virus (AAV) therapies means sponsors and contract development and manufacturing organizations (CDMOs) must identify creative and collaborative solutions in the early phases of development. In a recent webinar hosted by FUJIFILM Biotechnologies, Ian Goodwin, Director of CMC Program Design, provided his expert insight into the benefits of implementing early-phase studies like candidate screening and feasibility assessments for AAV manufacturing. In the post-webinar Q&A session, Goodwin tackled listener questions on manufacturability vs. clinical efficacy, regulatory support, and more.

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