White Paper

Leveraging Post-Translational Modifications & Biofunctional Assays For The Characterization Of Charged Variants

Source: Catalent
GettyImages-1397698830 Female scientist working on antiviral drug in laboratory

The production of protein-based drugs is complex and relies on using biological host systems. This inherent complexity can introduce slight variations within the protein structure, leading to the formation of protein variants. These variants, characterized by differences in size, charge, or folding, can significantly affect the drug's functionality. Such heterogeneity has the potential to compromise the safety and efficacy of the final therapeutic product. A critical aspect of biotherapeutic development involves the thorough characterization of charged variant profiles. Post-translational modifications (PTMs) can drastically alter protein charge, consequently impacting stability, pharmacokinetics (drug movement within the body), and pharmacodynamics (drug effects on the body). This article delves into protein variants, with a specific focus on charged variants, by elucidating their influence on protein-based drugs. We will explore how dedicated characterization techniques can be employed to ensure the safety and efficacy of these biotherapeutics.

Strategic collaboration with a Critical Quality Attribute (CQA) monitoring expert can facilitate protein variant characterization, quantification of their safety and efficacy impact, and address challenges associated with an increasing number of product variants. Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

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