Figure 2

Standardized production of SmyleDCpp65 under GMP compliant conditions. a Schematic flow diagram representing the production of a pilot batch of SmyleDCpp65 generation under GMP-like conditions and analyses. CD14⁺ monocyte selections from three independent leukapheresis were performed by CliniMACS. 1.5 × 10⁸ monocytes were transduced in bags with 7.5 × 10⁸ infectious particles (MOI of 5). Transduced monocytes were washed and cryopreserved. Analyses on day 0 after thaw for QC and batch release and on days 5 and/or 7 for identity and pharm-tox are shown. b CD14⁺ cell recovery as viable cell numbers after each step of production process and AT (extrapolated). c Percentage recovery of viable cells AT, days 5 and 7 after culture in medium without exogenous addition of cytokines (3 independent runs; n = 3 for each run).