The monitoring of charge heterogeneities of protein-based drugs is an integral part of any quality and product lifecycle management plan. Biologics are susceptible to various enzymatic and chemical post-translational modifications (PTMs) during their production process. These PTMs can significantly change the charge pattern and consequently lead to an alteration of the physical and chemical properties of a protein, such a solubility, stability, and binding affinity. To guarantee the efficacy and safety of biologics or biosimilars, it is inevitably to characterize the product-related impurities arising during the manufacturing process.
As regulatory agencies like FDA or EMA expect charge variants to be thoroughly characterized, a detailed analysis of deamidation, amidation, sialylation or pyroglutamate and lysin variants is of upmost importance during the development and commercialization of biologics.
The insights gained from these studies not only provide necessary knowledge about the product quality and safety, but also guides the development of process control strategies to avoid or reduce undesired charge variants.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), its individual formulation matrix and your distinct analytical question.
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