Manufacturing of CAR-T cells using in-house vectors and the CliniMACS Prodigy

Objectives: This article provides a practical, regulatory-focused guide for the clinical-grade manufacturing of autologous CAR-T cells using in-house lentiviral vectors and the CliniMACS Prodigy system. Methods: A narrative review and technical synthesis of the scientific literature, institutional manufacturing workflows, platform-specific protocols, and Brazilian and international regulatory documents were performed. Results: The detailed process includes leukapheresis, receipt of the material, chain-of-identity and chain-of-custody controls, and initial testing of the starting material, including total nucleated cell count, CD3+ cell content, viability, and microbiological screening. The Prodigy system utilizes automated modules for magnetic T-cell enrichment, CD3/CD28 activation, lentiviral transduction, cell expansion, harvesting, formulation, and cryopreservation. Operational conduct can affect reproducibility, starting material quality, transduction efficiency, and the cell culture process. Final product release is conditional on comprehensive quality control, and coordination among the laboratories is essential. Accordingly, quality assurance procedures, deviation and corrective and preventive action management, process validation, and traceability constitute essential components in a manufacturing center. Conclusion: Integrating manufacturing and quality procedures within a structured workflow facilitates platform standardization and automation, hence promoting consistent CAR-T-cell production.