Advancing CAR-T cell manufacturing in Latin America: Current landscape, future directions, and challenges

Area of Science:

• Oncology
• Biotechnology
• Health Policy

Background:

• Chimeric antigen receptor T cell (CAR T) therapy has revolutionized hematologic malignancy treatment.
• Significant barriers impede CAR T therapy access in Latin America, including high costs, regulatory fragmentation, limited manufacturing, and clinical readiness.
• A comprehensive understanding of the value chain is crucial for developing sustainable solutions.

Purpose of the Study:

• To review the current landscape of CAR T therapy in Latin America.
• To identify and synthesize practical strategies for sustainable manufacturing and delivery of CAR T therapy.
• To propose a staged roadmap for improving equitable and affordable access to CAR T therapy in the region.

Main Methods:

• Systematic review of the CAR T therapy value chain in Latin America.
• Analysis of instructive examples from India, Brazil, Mexico, Colombia, and Chile.
• Synthesis of regional experiences to propose a strategic roadmap.

Main Results:

• Successful domestic programs in India (talicabtagene autoleucel) demonstrate cost reduction and timeline shortening.
• Brazil, Mexico, Colombia, and Chile showcase diverse approaches to regulatory pathways, manufacturing, and research.
• Key enablers include domestic vector/cell processing, regulatory alignment, workforce development, and supportive infrastructure (cold chain, customs).

Conclusions:

• A staged roadmap prioritizing domestic capabilities, regulatory harmonization, and workforce development is proposed for Latin America.
• Network models and enabling systems are essential for efficient logistics and pharmacovigilance.
• Collaborative alliances and public investment are critical for securing policy support and achieving equitable CAR T therapy access.