The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics.

Examples of charged variants include lysine variants and deamidation products, both of which can impact stability by triggering degradation pathways. Aside from chemical characterization, charged variant analysis is an important tool to understand bio-functionality of biotherapeutics. In addition, structure-function assessment of the material supports decisions made related to product lifecycle management, both with regards to regulatory frameworks and by providing evidence of biological activity of all components.

Understanding the biological activity of components through a stability-indicating assay proactively provides the necessary information to address product stability.

During this webinar, a panel of experts from Catalent Biologics will discuss successes and challenges involved with isolation, purification, and characterization of charged variants of biotherapeutics products, including monoclonal antibodies and fusion proteins.