Scalable CAR-T production in a 2-litre perfusion stirred-tank bioreactor with automated harvesting and scale-down model characterisation.

ABSTRACT: The emergence of allogeneic, universal chimeric antigen receptor (CAR) T cell therapies requires intensified and scalable manufacturing workflows supported by representative scale-down models (SDMs) to enable efficient process development and future large-scale production of off-the-shelf therapies. Here, we present a 7-day CAR-T cell expansion process intensified via perfusion of serum-free medium in a 2 L Univessel® Single-Use stirred-tank bioreactor (STR), consistently achieving 30 × 10⁶ cells/mL, corresponding to 113 ± 7 anti-CD19 CAR-T doses per batch. Parallel runs in 250 mL Ambr® 250 STRs conducted at equivalent volumetric power input (P/V) of ∼8.78 W/m³ demonstrated comparable process performance and final product quality, with univariate and multivaria

SUBMITTER: Springuel P 

PROVIDER: S-EPMC12833271 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature