FDA seeking more consistency from Cell & Gene Therapy (GCT) developers
Cell and gene therapy is a fast-growing industry with remarkable promise. The FDA supports CGT developers but is pressing for “more consistently measured characteristics of their often complex products.” Issues are presenting themselves in manufacturing and testing of treatments. According to Peter Marks, head of the regulator’s biologic drugs division, consistency is more challenging with CGT because “developers ger very excited about the fact that their product produces an important effect that they don’t worry as much about reproducibly making that product.”
Manufacturing these therapies is not as straight forward as ramping up production of component parts. Biological material like patient cells or viruses are regularly required to create individualized treatments. Clinical trials for “first of their kind” treatments also pose challenges to developers but Marks states, “Pick something. Pick some quality of the cell. Pick something that you think might correlate and measure that. We’ll [the FDA] take any offers that are reasonable.”
The FDA is working to create overview and regulations for the field and is even taking steps by expanding the Centers for Biologics Evaluation and Research (CBER) division. Negotiations for additional funding are in the works. The agency expects to approve 10 to 20 CGT a year by 2025 (in addition to the two treatments currently approved).
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