LAUSR

Background Post-translational modifications in bioprocessing and storage of recombinant mAbs are the main sources of charge variants. While the profile of these kinds of variants is considered an important quality attribute of therapeutic mAbs, there is controversy about their direct role on safety and efficacy. In this study, the physicochemical and PK properties of separated charge variants belonging to a trastuzumab potential biosimilar were examined. Methods The APs, BPs, and main variants of trastuzumab were separated and enriched by semi-preparative WCX. A panel of analytical techniques was utilized to characterize the physicochemical properties of these variants. The binding affinity to HER2 and FcγRs and the PK parameters were evaluated for each variant. Results Based on the results, the charge variants of the proposed biosimilar had no significant influence on the examined efficacy and PK parameters. Conclusion During the development and production of biosimilar mAbs, studying the effects of their charge variants on efficacy and PK parameters is needed.