Overcoming challenges to CAR-T cell therapies in India

Chimeric antigen receptor (CAR)-T cell therapies are promising treatments for previously untreatable cancers. However, many hurdles still need to be cleared before these products become widely accessible, especially to patients in low- and middle-income countries. One significant challenge that prospective cell therapy manufacturers face in emerging markets is access to raw materials, such as donor cells and viral vectors. This problem is not simply a lack of domestic sources for raw materials but, more importantly, the inability to consistently validate their quality. To address how best to approach these issues, USP-India organized a panel discussion on challenges faced by Indian CAR-T cell therapy developers at Global Bio-India 2021. Topics discussed include local manufacturing capacity, access to critical raw materials, requirements for analytical methods, release assays, and control procedures. This article summarizes some of the critical issues and recommendations raised by experts from academia, industry, and government.

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