Impurity / Aggregation Analysis

Given the complex structures of biopharmaceuticals, there is a possibility for the induction of enzymatic and non-enzymatic modifications during production, storage, and transportation. Protein samples may aggregate during production and storage, which is inappropriate because it could result in immunogenicity or issues with medicine administration (large aggregates). On the other hand, subvisible and submicron aggregates and host cell proteins pose particular difficulties among the impurities. Every biopharmaceutical development stage is impacted by product- and process-related contaminants, from discovery to development to manufacturing. Due to the potential link between aggregation and increased immunogenicity of the biotherapeutics, finding, identifying, and characterizing these variants and impurities are of serious regulatory concern. Size Exclusion Chromatography (SEC), SEC-MALS, provides a qualitative and quantitative assessment of monomers and aggregates. Sedimentation velocity analytical ultracentrifuge SV-AUC can assess antibody aggregates with diameters less than 100 nm.