Leveraging Post-Translational Modifications And Bio-Functional Assays For Characterization Of Charged Variants

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 post-translational modifications (PTMs) impart or alter the charge of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Additionally, 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.

In this webinar, Catalent experts discuss challenges associated with charged variants of biotherapeutic products, including monoclonal antibodies and fusion proteins.