推动拉丁美洲 CAR-T 细胞生产：现状、未来方向与挑战

Chimeric antigen receptor T cell therapy has transformed outcomes in hematologic malignancies, yet access in Latin America remains limited by high costs, fragmented regulation, constrained manufacturing capacity, and uneven clinical readiness. This review synthesizes the regional landscape and distills practical strategies to advance sustainable manufacturing and delivery.

We map the full value chain from discovery to routine care, highlighting instructive examples. India's talicabtagene autoleucel program built domestic vector and cell production to lower cost and shorten timelines, Brazil coupled a mature regulatory pathway with accredited centers and an emerging national platform for vectors and plasmids, Mexico demonstrated feasibility of hospital based closed system production under national oversight; Colombia and Chile are developing academic pipelines and locally relevant targets.

From these experiences we propose a staged roadmap for Latin America that prioritizes domestic capability in vectors and cell processing, regulatory alignment to trusted standards, and workforce development anchored in manufacturing standards and consensus. Network models that combine reference centers with point of care manufacture can reduce logistics burden.

Enabling systems are essential, reliable cold chain, precleared customs lanes for critical inputs, pharmacovigilance, and shared minimum datasets for outcomes and safety. Emerging technologies, including non viral nanoparticle transfection and artificial intelligence for construct selection and process control, can reduce costs and improve consistency if advanced through careful, stepwise evaluation.

Finally, coordinated alliances among hospitals, professional societies, patient groups, academia, and industry are needed to secure policy support and public investment.

Together, these measures provide with a realistic path to safe, equitable, and affordable access to CAR T therapy in Latin America.