Supplementary Figure 9: Production of G-CSF using multiple InSCyT systems.
From: On-demand manufacturing of clinical-quality biopharmaceuticals

Dose size was 300 μg24. Center points and error bars represent the mean and range, respectively, of technical triplicates unless otherwise noted. Fermentograms and UV profiles from chromatography operations on three InSCyT systems during G-CSF production. DO, dissolved oxygen; SLPM, standard liters per minute. Timeline and yields for production of G-CSF using three InSCyT systems. Wet cell weight (WCW) (black circles) and cumulative unpurified (orange) and formulated (blue) doses of G-CSF are shown. Grey circles show individual data points. Analysis of the tertiary structures of InSCyT G-CSF and a de-identified marketed product using circular dichroism (CD). Analysis of additional product-related variants. Black boxes represent the range of InSCyT G-CSF samples (Batches 1-6) with an additional line at the mean. SDS-PAGE (12% tris-glycine) analysis of samples from the USP during biomass accumulation (Perfusate Sample #0) and production (Perfusate Sample #1,2), and a final, formulated InSCyT sample (Formulated Sample #1,2) alongside a G-CSF marketed drug product (Std). M, molecular mass marker. Analysis of product purity by isoelectric focusing (IEF) for a formulated sample from each system. M, IEF protein marker. Example RPLC and SEC chromatograms used to quantify purity of G-CSF (representative of all six batches).