Overcoming Roadblocks Along The Cell Therapy Product Pathway

By Tim Tripp

Cell and gene therapy remains a new therapeutic class with an infrastructure immersed in clinical trials. This is true even with 22 approved cellular and gene therapy products licensed through the FDA’s Office of Tissue and Advanced Therapies in the U.S. as of Oct. 19, 2021.

As more therapies receive commercial approval, biotech executives will face challenges unlike those experienced with traditional pharmaceuticals. These challenges begin with the source material and continue through therapy infusion. However, biotech executives can take steps to minimize some of these challenges throughout the cell therapy product pathway and scale efficiently.