Engineering a Medical Revolution

Manufacturing immunotherapies in machines, instead of by hand, could reduce errors and improve access to these promising cancer drugs

When Novartis’s cancer treatment Kymriah was approved by the U.S. 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. Like other CAR-T treatments, though, Kymriah is difficult to make and is produced specially for each patient. Novartis set its price at US $400,000 per treatment.

But before long, Novartis was simply giving Kymriah away for free to some patients. The company couldn’t consistently manufacture the drug to meet the specifications spelled out in the FDA’s approval. Doses that were outside of those specifications couldn’t legally be sold.

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. 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.

But for all the promise, the challenges of manufacturing cell therapies are making it hard to deliver the actual treatments. “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.

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