Decentralized manufacturing: from stem cell transplants to the next generation of cellular immunotherapies

Cell and gene therapies are emerging as pillars of modern medicine. Yet, there remain significant challenges related to drug product manufacturing scale out, accessibility, and overall pricing of these potentially curative therapies. To date, drug developers have pursued more traditional models of centralized manufacturing to enable for the commercial scale out of approved cell and gene therapies. These traditional manufacturing models enable process and product control. The pursuit of a centralized manufacturing model for autologous personalized cell and gene therapies, however, could lead to significant complexity with respect to overall logistics and manufacturing costs. A more distributed model of manufacturing can potentially provide patients with faster access to drug product and lead to greater overall cost savings. A decentralized model, could however, also lead to significantly less process and product control for the drug developer. This brief article will examine the potential path that drug developers can pursue to enable decentralized manufacturing for commercial cell and gene therapies. Specifically, we discuss the existing stem cell transplant center infrastructure in the USA and how it may be leveraged to enable for a more decentralized model of manufacturing.

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