Development of a fully automated formulation and fill process
(A) Filling accuracy in product, retain, and QC bags filled in buffer runs (expressed as percentage of expected value); n = 66 for product bags, six for retain bags, 17 for QC bags; solid/dotted lines indicate target, 5% and 15% variability. (B) DMSO concentration measured by osmolality against a standard curve with known DMSO concentrations in product, retain, and QC bags filled in buffer runs; n = 30 for product bags, 10 for retain bags, six for QC bags; dotted line indicates target of 5%. (C) Cell concentration in product bags from runs expressed as the percentage of expected concentration (solid/dotted lines indicate target, 5% and 15% variability), n = 15 bags across four runs, graph shows mean + SD, one-way ANOVA with multiple comparisons (Dunnett’s multiple comparisons test). (D) Viability in product bags from runs (dotted line shows acceptance criterion of ≥70%), n = 15 bags across four runs, one-way ANOVA with multiple comparisons (Dunnett’s multiple comparisons test). Graphs show individual data points with mean + SD.