Charge variants of proposed biosimilar to Omalizumab: Isolation, purification and analysis by HPLC methods.

This study investigates charge variants of proposed biosimilar to omalizumab: isolation, purification and analysis by hplc methods.. The research utilizes high-performance liquid chromatography (HPLC) as the primary analytical technique to address specific challenges in pharmaceutical analysis. Omalizumab (Xolair) is a humanized monoclonal antibody derived by recombinant DNA technology. It binds specifically to immunoglobulin E (IgE) which plays a major role in allergic reaction by releasing histamine and other inflammatory factors from mast cells. Omalizumab binds circulatory IgE with high affinity and prevents from its binding to... Research Background and Significance Monoclonal antibodies (mAbs) such as omalizumab have revolutionized therapeutic interventions for allergic diseases by targeting immunoglobulin E (IgE) and preventing its interaction with effector cells. Omalizumab, a recombinant humanized mAb marketed as Xolair, is widely used to treat moderate to severe allergic asthma and chronic idiopathic urticaria. Biosimilars to such complex biologics are increasingly important for improving patient access and reducing healthcare costs. However, due to their intrinsic structural complexity, biosimilars often exhibit heterogeneity in post-translational modifications, including charge variants arising from deamidation, glycosylation, or other chemical modifications. These charge variants can influence efficacy, stability, and immunogenicity. Thus, robust analytical techniques are required for their characterization. This study focuses on isolating and analyzing charge variants of a proposed biosimilar to omalizumab using high-performance liquid chromatography (HPLC), a gold standard in biopharmaceutical quality control. The investigation provides essential insight