Storage stability evaluation was performed on RM 8671 lot 14HB-D-001 and extrapolated for all other RM 8671 lots. Samples reserved for thaw/freeze stability and accelerated stability analyses were reserved as indicated in the ESM (see Table S15 and Table S16). T/F samples were tested using the qualified physicochemical assays or optimized informational value assays (at a minimum) described above after undergoing an additional one to five T/F cycles with freeze temperature at −80 °C or −20 °C. Accelerated stability samples were analyzed using the qualified physicochemical assays or optimized informational value assays described above at the (0, 7, and 28) day time points described in the ESM (see Table S16). The one day time points were also analyzed with SEC to provide more fine-detail in excursions from the control limits at elevated temperatures. Control charts for alternative storage stability evaluations displaying measurement results for the various stability conditions, with control range taken as the mean value of the unstressed material (±2uc for UV and ±3uc for physicochemical assays), are depicted in Fig. 8. A larger control range of ±3uc was utilized for physicochemical assays compared to the concentration measurement because of the fewer degrees of freedom and increased measurement variability observed during value assignment. In addition, the UV concentration measurement is expected to be less sensitive to degradation, yet deviations in concentration may have significant impact on other physicochemical measurements.Fig. 8Physicochemical method results for 14HB-D-001 under accelerated stablity (left) and thaw/freeze conditions using (a) UV-Vis, (b) CZE, (c) SEC, and (d) nrCE-SDS. The black lines indicate a control range taken as the mean value of unstressed 14HB-D-001 ± 2uc for UV-Vis and ±3uc for physicochemical assays