Carge Variant Analysis & Charge Heterogeneity Services
Charge heterogeneity is a key critical quality attribute (CQA) of protein-based drugs and an integral part of any quality and product lifecycle management plan. Biologics are susceptible to various enzymatic and chemical post-translational modifications (PTMs) during production and storage. These PTMs can change the overall charge pattern of the molecule and, as a result, alter important physicochemical properties such as solubility, stability and binding affinity. To ensure the efficacy and safety of biologics and biosimilars, it is essential to characterize product-related charge variants and impurities arising during the manufacturing process.
Regulatory agencies like FDA and EMA expect charge variants to be thoroughly characterized and controlled. A detailed analysis of acidic and basic variants arising from deamidation, sialylation, C-terminal lysine variants, N-terminal pyroglutamate formation, amidation and other PTMs is therefore crucial throughout the development, commercialization and lifecycle management of biologics. The insights gained from these studies not only provide critical information on product quality and safety, but also guide the development of process control strategies to avoid or reduce undesired charge variants.
At Biofidus, we design fit-for-purpose charge variant and charge heterogeneity studies using state-of-the-art capillary electrophoresis and chromatography methods. In accordance with your needs, we adapt and, where required, qualify (according to ICH guidelines) our platform methods, tailoring them to your drug substance (DS), its formulation matrix and your specific analytical questions , from early development and comparability to release and stability testing.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
