Highly purified charge variants of a proposed biosimilar to Omalizumab: impact on in vitro potency and stability under thermal stress

In this study, highly purified charge variants cluster (acidic, main peak and basic) of biosimilar product of Xolair were assessed for their impact on in vitro potency and stability at different thermal stress conditions (2-8 °C and - 20 °C). The study data indicating purified charge variants (> 90%) have no impact on in vitro potency and are stable at different thermal stress conditions up to a week.PMID:38156991 | DOI:10.1007/s00449-023-02944-8
Source: Bioprocess and Biosystems Engineering - Category: Biomedical Engineering Authors: Source Type: research