In 2016, Miltenyi Biotec released a tabletop device called the CliniMACS Prodigy that takes in a patient’s cells and automatically moves them through several steps required to produce a CAR-T treatment: separating cells, washing them, culturing them, and even injecting viruses into them to modify specific genes. Experts say automating the manufacture of cell therapies could help, and many researchers are working on doing just that. These highly manual techniques make CAR-T treatments expensive and prevent companies from making a lot of them. “You have really high-skilled technicians who say, ‘I look at the cells and I know when to harvest,’ and, ‘In my hands, it works.’” “ is an art right now,” says Ohad Karnieli, president and cofounder of Atvio Biotech. “We’re still banging into fundamental challenges of manufacturing a living cell–based product,” says Scott Burger, a long-time consultant in the cell-therapy industry.ĬAR-T treatments are produced largely the same way-manually, in specialized clean rooms, in steps that are not easily standardized. CAR-T is one of the most promising fields in medicine and at the end of 2018, there were more than 400 CAR-T trials going around the world.īut for all the promise, the challenges of manufacturing cell therapies are making it hard to deliver the actual treatments. Novartis’s costly manufacturing issues are representative of the state of cell therapy, which includes CAR-T and other treatments where living cells are injected into a patient.
Doses that were outside of those specifications couldn’t legally be sold. The company couldn’t consistently manufacture the drug to meet the specifications spelled out in the FDA’s approval. Novartis set its price at US $400,000 per treatment.īut before long, Novartis was simply giving Kymriah away for free to some patients. Like other CAR-T treatments, though, Kymriah is difficult to make and is produced specially for each patient. Food and Drug Administration in 2017, it signaled the arrival of CAR-T, a much-hyped form of therapy that proved stunningly effective at curing some hard-to-treat forms of cancer in trials. When Novartis’s cancer treatment Kymriah was approved by the U.S.
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