Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer.

ABSTRACT: There is a growing demand for chimeric antigen receptor (CAR) -T cells for clinical trials. Consequently, new centers capable of manufacturing advanced therapy medicinal products (ATMPs) are needed. In this study, we established a good manufacturing practice -compliant manufacturing process and phase-appropriate analytics for a novel autologous CD19-targeted CAR T-cell product, 19-FiCART. We evaluated the stability of fresh, healthy donor-derived leukapheresis products (LPs), produced 19-FiCART using a 12-day semi-automated process with CD4/CD8-positive cell enrichment and lentiviral transduction, and evaluated the in vivo efficacy of 19-FiCART in a xenograft mouse lymphoma model. The optimal hold time and temperature to maintain LP stability were up to 73 h at 2-8 °C. The 19-FiCART manufa

SUBMITTER: Luostarinen A 

PROVIDER: S-EPMC11890757 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature