One of the biggest hurdles in commercializing cell therapies is not the regulatory process, nor is it marketing a brand new, first-in-class product. Instead, many feel that the biggest challenge facing companies developing cell and gene therapies is proving to be the manufacturing process.
Manufacturing CAR-T therapies presents multiple unique challenges. First, developing a personalized cancer medication requires genetically coding a patient’s own T-cells to attack and kill cancer cells, a complex process that must be accomplished in a timely manner, as the resulting therapies must be delivered as quickly as possible, before a patient’s cancer cells can further mutate.
Second, as the The New York Times and several other industry news sources reported at the end of 2017, another unique problem is vexing cell and gene therapy companies – a shortage of the disabled viruses that are used as vectors for delivering normal cells for a patient’s benefit.
While news of manufacturing shortages has become more visible with the recent approvals of the first CAR-T therapies, this is not a new issue, and one that companies developing cell therapies have been attempting to mitigate for several years, primarily by taking the manufacturing process into their own hands. Both Kite and Novartis, for instance, opened their own CAR-T manufacturing plants. Kite opened its plant next door to an airport, to make it simpler to rapidly transport its product to patients waiting for treatments.
We are now seeing companies in earlier stages of development take a similar approach. Late in 2017, Bluebird Bio made a splash when it announced it had purchased a facility to be used for manufacturing the viral vectors used in the production of its therapies. In Europe, the British cellular immunotherapy company Cell Medica made a similar announcement, striking a deal to acquire Catapult Therapy TCR, and in the process gaining access to an existing manufacturing site in the UK. We anticipate seeing more such deals in the year to come.