Cell therapy's yada yada yada

The novel science and dramatic clinical results behind chimeric antigen receptor (CAR) T cells and other cell therapies have the technology labeled by many as one of the most promising advances in biotech. But away from the limelight, companies and researchers are working to address the less glamorous steps in between discovery and the clinic, in particular the manufacturing challenges several stakeholders believe represent make-it or break-it factors for cell therapy products.

Last month's announcement by Kite Pharma Inc. of problems for one of its products at an NIH manufacturing facility was one example of the CMC issues that have concerned the field from the start. On April 16, Kite issued a press release stating it is pausing enrollment of patients in a joint clinical trial with NIH's National Cancer Institute (NCI) pending a voluntary review of the institute's cell therapy manufacturing facilities. ...