Liquid Chromatographic Pattern
Protein aggregation and degradation products as well as heterogeneity in charge variants are fundamental characteristics implicated in the stability, biological activity and immunogenicity of the therapeutic monoclonal antibody. These characteristics can be indicative of the nature of the clonal cell line, the manufacturing process or the stability of the drug, and as such can be used throughout the biological development cycle.
Size Exclusion Chromatography
BioOutsource can offer low dispersion, high resolution chromatographic methods to identify high and low molecular weight variants of your monoclonal antibody product, while also evaluating the consequence on binding and functional activity. This methodology also provides information on chromatographic patterns as required by ICH Q6b providing information on identity, homogeneity and purity.
Ion Exchange Chromatography
BioOutsource also offer Ion Exchange Chromatography (IEX). You can find more information on this method on our charge variant page.
A comparative approach can also be implemented for developers of biosimilar mAb therapeutics. We run side by side analysis of the biosimilar material to a reference material. This can highlight examples whereby issues may arise in proving fingerprint-like similarity.
Performing reversed-phase (RP) chromatography is important in the characterization of monoclonal antibodies because it provides important information about product purity. Separation is based on hydrophobicity and therefore RP chromatography offers orthogonal selectivity to other techniques, such as size-exclusion chromatography and ion exchange chromatography. It is particularly relevant for IgG2s, which can have structurally distinct forms caused by different disulfide bond structures.
Contact our experts today to discuss your liquid chromatography requirements.