It is clear from Fig. 4 that RM 8671 does not conform to the values determined for PS 8670. The relative area of the monomer has decreased from ≈98.7% in PS 8670 to ≈96.7% in RM 8671 and the relative area of the high molecular weight species has increased from ≈1% to ≈3% (ESM Table S7). Despite a small increase in the % HMW versus PS 8670, the three lots of RM 8671 were shown to be consistent with one another in terms of monomeric purity, high molecular weight relative area and low molecular weight relative area. Figure 4 demonstrates that good inter-lot reproducibility was achieved for each of the three 14HB-D lots, and that each material was observed to contain % monomer, % HMW, and % LMW to within ±3uc of one another. Alterations in the homogenization and vial filling process and/or an increased presence of HMW species in one of the constituent batches, versus the PS 8670 material, are thought to have resulted in the increased HMW species. Despite a small increase in the % HMW versus PS 8670, it is the inter-lot homogeneity of the commercial (RM 8671) lots that is important in ensuring a consistent product to stakeholders, which the current data indicate will be true considering the statistical equivalence of all three commercial lots with respect to aggregates based on SEC.