Companies Clearing Cell And Gene Therapy Manufacturing Hurdles
This article was originally published in Scrip
The promise of cell and gene therapies is great, but there's a lot of work to be done between selecting a clinical candidate and eventually selling an approved product, and companies have learned that commercial scale manufacturing is a challenge that has to be addressed early on in development.
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Tmunity launched in early 2016 with $10m in seed funding for novel T-cell therapies, two of which are now in the clinic. The company reunites former Novartis cell therapy head Oz Azam and CAR-T researchers from the University of Pennsylvania.
Novartis reported positive early results for its lead CAR-T candidate CTL019 in DLBCL that appear to be consistent with Kite's competing therapy in the same indication, but the data show the Swiss big pharma ran into manufacturing issues that weren't resolved until later in the JULIET study.
Novartis's consolidation of its cell and gene therapy division into its corporate R&D operation has other leading CAR-T developers defending their therapeutic candidates against technical and manufacturing doubts.