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Advanced Therapy Manufacturing

Cell and gene therapies represent an emerging paradigm, and the future of advanced therapies. As of early 2022, the U.S. Food and Drug Administration (FDA) has approved four gene therapies1 and six cell-based treatments.2 Two additional gene therapies are approved in the EU.

Approvals only tell part of the story, however. More than 1600 gene therapies3 are currently in clinical trials, and the FDA has to date received more than 900 applications to initiate gene-based treatments.4 The agency expects that by 2025 it will issue upwards of 200 investigational new drug (IND) applications for advanced therapies per year, with approval of up to 20 such treatments. This unprecedented growth comes with unique challenges for advanced therapy developers and manufacturers, which often center around the three essentials of quality, speed and innovation.

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May 2, 2022