Cell and gene therapies won’t enter the mainstream of medicine until manufacturing processes become far more efficient, according to FDA Commissioner Scott Gottlieb and FDA Center for Biologics Evaluation and Research Director Peter Marks. The agency hopes to play a major role in making manufacturing improvements possible, they told BioCentury.
In the U.S., groups like the Alliance for Regenerative Medicine (ARM) and Friends of Cancer Research are working with FDA, manufacturers and academic investigators on standards and new regulatory approaches to topics like comparability and standards that could lay the groundwork for industrializing the manufacturing of new modalities.
Regulatory authorities in Europe and Japan are also collaborating with industry and academic investigators to streamline manufacturing. There are concerns in Europe, however, that a fractured regulatory structure is holding back regenerative medicine (see “Regulating Regeneration in Europe”).
Creating regulations that both enable progress and ensure safety raises unique challenges in cell and gene therapies because the products often reach the market with limited clinical testing, and can be incorporated into patients’ bodies in ways that