Biotherapeutics comprise a diverse class of protein-based drugs with intricate structural and functional characteristics. They exhibit inherent heterogeneity arising from various sources, including manufacturing processes, formulation conditions, and storage. Comprehensive understanding and characterization of these product-related variants are important to ensure the safety, efficacy, and quality of biotherapeutics, as well as for timely regulatory approval. Characterization typically involves isolating charge, size, and hydrophobicity variants, and identifying and quantifying their relative abundances in the drug product. This is achieved using advanced analytical tools such as semi-preparative chromatography, size- and charge-based HPLCs technologies, mass spectrometry (MS), CE-SDS, among others. Additionally, functional assessments are performed using cell-based assays and binding assays to evaluate the impact of variants on bioactivity. Our work highlights various techniques employed to elucidate the complexity of product-related variants in biotherapeutics, with a primary focus on a pegylated cytokine and monoclonal antibody.

Fill out the form to download the poster >>>