ArticleJournal of translational medicine2026
Bridging preclinical development and clinical manufacturing: a translational GMP-Platform for lentiviral vector production in academic CAR T-Cell therapy.
Article in Journal of translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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13 authors.
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Abstract
backgroundThe manufacturing of lentiviral vectors (LV) under Good Manufacturing Practices (GMP) remains a critical bottleneck limiting the clinical translation of academic CAR T-cell therapies. To address this challenge, we established and validated an integrated GMP facility (ViPro-IBiS-UPRC) for aseptic LV production within a public healthcare setting.
methodsA stepwise optimization strategy was implemented to bridge preclinical development and GMP manufacturing, including refinement of transfection conditions, vector harvest timing, and scale-up surface transition. GMP-compliant production processes and quality control (QC) frameworks were subsequently developed and validated for HEK293T Lenti-X master and working cell banks (MCB/WCB) and for LV manufacturing.
resultsCell banks demonstrated high viability (≥94%), robust expansion capacity, confirmed identity by DNA fingerprinting, and absence of microbial and viral contaminants, including adventitious and endogenous retroviruses. GMP-produced LV batches achieved functional titers ranging from 9.95 × 10
conclusionsCollectively, this work establishes a GMP-compliant academic platform for scalable LV manufacturing, enabling decentralized, cost-effective, and clinically compliant supply. This point-of-care manufacturing model strengthens the accessibility of academic CAR T-cell therapies within public healthcare systems.
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