Protein aggregation, degradation products, and charge variant heterogeneity are key factors that influence the stability, biological activity, and immunogenicity of therapeutic monoclonal antibodies. These characteristics can provide valuable insights into the clonal cell line, manufacturing processes, and the overall stability of the product is critical throughout the biological development lifecycle.
Size Exclusion Chromatography (SEC) is vital for assessing the purity, aggregation, size distribution, and stability of therapeutic monoclonal antibodies. By detecting aggregates, degradation products, and molecular heterogeneity, SEC plays a crucial role in ensuring that therapeutic mAbs meet the stringent regulatory requirements for approval and clinical use.Aragen can provide Quick, robust and high-throughput method which can monitor the higher molecular species across the product development.
Ion-Exchange Chromatography (IEX) is a powerful technique to evaluate charge variants of proteins. Assessing charge heterogeneity is crucial in the development, quality control, and stability testing of therapeutic mAbs, as it can influence the safety, efficacy, and immunogenicity of the drug.Charge heterogeneity refers to the presence of protein species with different net charges, which can arise from various factors such as post-translational modifications (PTMs) (e.g., glycosylation, deamidation, oxidation), or differences in the manufacturing process.
Aragen can provide seamless support to monitor the charge heterogeneity across the product development to ensure the desired product quality in the finished product.
Reversed phase (RP) chromatography supports the characterization of monoclonal antibodies by revealing important information about product purity. Separation is based on hydrophobicity. It is particularly relevant for IgG2s, which can have structurally distinct forms caused by different disulfide bond structures.
Disulfide scrambling by RP-LC is a crucial tool for assessing the structural integrity and stability of IgG2 monoclonal antibodies. By monitoring the hydrophobicity changes resulting from disulfide bond alterations, RP-LC helps detect scrambled species, aggregates, and degradation products. This provides valuable insights into the quality of the therapeutic protein.
Schematic of IgG2 disulfide isoforms mediated by different configurations of the inter-chain disulfide bonds. The inter-chain disulfide bonds are represented by red lines.