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Cell therapy's yada yada yada

Challenges and solutions for GMP manufacturing of cell therapies

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.

The company noted that the pause will not affect its lead compound KTE-C19, a CAR T cell therapy targeting CD19 that is in pivotal Phase I/II and Phase II trials for hematologic malignancies. In January, Kite reported that in a trial in 41 patients with hematologic malignancies, KTE-C19 led to an overall response rate (ORR) of 78%, including 22 complete responses.

Other cell therapy companies have produced positive clinical data as well, including Novartis AG, whose CTL019 CD19-targeted cell therapy is in Phase II for several hematological malignancies; Juno Therapeutics Inc., whose JCAR015 CAR T cell therapy targeting CD19 is in Phase II for acute lymphoblastic leukemia (ALL); and Cellectis S.A., whose UCART19 CD19-targeting CAR T cell therapy caused remission in a single patient treated on a compassionate use basis. UCART19 is scheduled to enter Phase I this year.

Most of these companies have chosen to invest directly in manufacturing facilities, rather than relying

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