Manufacturing new modalities

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...