Description: Biotherapeutics heterogeneity has implications for the efficacy and stability of the final Biotherapeutic or Biosimilar Products. Charged Variant profiles are of particular utility since many important Post-translational Modifications (PTMs) impart or alter the charge (pI) on the molecule. The determination of some level of structure-function assessment supports product lifecycle critical quality attributes which are considered with respect to product release and stability specifications.
Learning Objectives:
Charged variant analysis is an important tool to understand bio-functionality of biotherapeutics.
Understanding the biological activity of components through a stability-indicating assay proactively provides the necessary information to address product stability.
Several approaches may be applied to overcome challenges with isolation, purification, and characterization of charged variants of biotherapeutics products.
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