<p>Chimeric antigen receptor T (CAR-T) cell therapy has redefined the therapeutic landscape for refractory hematological malignancies and is increasingly explored for solid tumors. Despite its transformative potential, global deployment remains restricted due to prohibitive manufacturing costs, technical complexity, and infrastructure limitations challenges that disproportionately affect low- and middle-income countries (LMICs). India, however, with its confluence of biomedical innovation, scalable infrastructure, and a high cancer burden, offers a unique opportunity to reimagine CAR-T cell therapy through frugal yet high-quality innovation. It is hypothesized that India can emerge as a global leader in precision oncology by integrating indigenous scientific advancement, academic–industrial collaborations, and decentralized bio manufacturing platforms to create cost-effective and clinically potent CAR-T therapies. This review critically examines India’s current CAR-T research ecosystem, including early clinical trials, government-backed translational programs, regulatory evolution, and innovations aimed at addressing both disease-specific and population-scale needs. The discussion emphasizes next-generation strategies such as allogeneic “off-the-shelf” CAR-T platforms, tandem antigen targeting, AI-driven analytics, and point-of-care cell processing all of which contribute to lowering costs and increasing reach without compromising safety or efficacy. Additionally, ethical considerations, reimbursement models, and policy interventions are analyzed to highlight what is required for widespread adoption within India’s diverse healthcare system. India’s leadership in developing scalable, affordable CAR-T therapies not only addresses domestic unmet needs but also sets a precedent for LMICs globally. This approach offers a replicable and sustainable framework to democratize access to curative cellular immunotherapies in the emerging era of precision oncology.</p> Graphical abstract <p><b>India’s Global Collaborations and CAR-T Cell Manufacturing Workflow.- Panel A</b>. India’s global collaborations in cell and gene therapy are depicted according to the type and direction of partnership. <b>Blue</b> indicates strategic and technological alliances, <b>red</b> represents clinical and regulatory collaborations, <b>green</b> denotes manufacturing or technology-transfer hubs, <b>yellow</b> highlights academic and knowledge-exchange initiatives, and <b>black</b> marks commercial or market-launch operations. Unidirectional arrows illustrate the flow of expertise, regulatory knowledge, and technology from partner regions to Indian institutions engaged in CAR-T and gene-therapy development. <b>Panel B. Schematic representation of the CAR-T cell manufacturing process</b>. The workflow begins with <b>leukocyte apheresis</b>, in which peripheral blood mononuclear cells (PBMCs) are collected from the patient as the source material. T cells are subsequently activated and genetically engineered to express a chimeric antigen receptor (CAR), ensuring antigen specificity. These modified T cells undergo rigorous ex vivo expansion under controlled culture conditions, followed by comprehensive quality control testing for viability, transduction efficiency, and functional potency. The final CAR-T product is cryopreserved until patient administration. Following <b>lymphodepletion</b>, infusion of the CAR-T cells mediates targeted tumor recognition, immune synapse formation, and cytolytic activity, establishing a durable, antigen-specific anti-tumor immune response.</p>

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Revolutionizing cancer care in India: pioneering low-cost, next-generation CAR-T cell therapies to position India as a global leader in precision oncology

  • Arpita Mukherjee

摘要

Chimeric antigen receptor T (CAR-T) cell therapy has redefined the therapeutic landscape for refractory hematological malignancies and is increasingly explored for solid tumors. Despite its transformative potential, global deployment remains restricted due to prohibitive manufacturing costs, technical complexity, and infrastructure limitations challenges that disproportionately affect low- and middle-income countries (LMICs). India, however, with its confluence of biomedical innovation, scalable infrastructure, and a high cancer burden, offers a unique opportunity to reimagine CAR-T cell therapy through frugal yet high-quality innovation. It is hypothesized that India can emerge as a global leader in precision oncology by integrating indigenous scientific advancement, academic–industrial collaborations, and decentralized bio manufacturing platforms to create cost-effective and clinically potent CAR-T therapies. This review critically examines India’s current CAR-T research ecosystem, including early clinical trials, government-backed translational programs, regulatory evolution, and innovations aimed at addressing both disease-specific and population-scale needs. The discussion emphasizes next-generation strategies such as allogeneic “off-the-shelf” CAR-T platforms, tandem antigen targeting, AI-driven analytics, and point-of-care cell processing all of which contribute to lowering costs and increasing reach without compromising safety or efficacy. Additionally, ethical considerations, reimbursement models, and policy interventions are analyzed to highlight what is required for widespread adoption within India’s diverse healthcare system. India’s leadership in developing scalable, affordable CAR-T therapies not only addresses domestic unmet needs but also sets a precedent for LMICs globally. This approach offers a replicable and sustainable framework to democratize access to curative cellular immunotherapies in the emerging era of precision oncology.

Graphical abstract

India’s Global Collaborations and CAR-T Cell Manufacturing Workflow.- Panel A. India’s global collaborations in cell and gene therapy are depicted according to the type and direction of partnership. Blue indicates strategic and technological alliances, red represents clinical and regulatory collaborations, green denotes manufacturing or technology-transfer hubs, yellow highlights academic and knowledge-exchange initiatives, and black marks commercial or market-launch operations. Unidirectional arrows illustrate the flow of expertise, regulatory knowledge, and technology from partner regions to Indian institutions engaged in CAR-T and gene-therapy development. Panel B. Schematic representation of the CAR-T cell manufacturing process. The workflow begins with leukocyte apheresis, in which peripheral blood mononuclear cells (PBMCs) are collected from the patient as the source material. T cells are subsequently activated and genetically engineered to express a chimeric antigen receptor (CAR), ensuring antigen specificity. These modified T cells undergo rigorous ex vivo expansion under controlled culture conditions, followed by comprehensive quality control testing for viability, transduction efficiency, and functional potency. The final CAR-T product is cryopreserved until patient administration. Following lymphodepletion, infusion of the CAR-T cells mediates targeted tumor recognition, immune synapse formation, and cytolytic activity, establishing a durable, antigen-specific anti-tumor immune response.