Commentary: New perspectives on protein aggregation during Biopharmaceutical development

Abstract

The occurrence of protein aggregation during bioprocessing steps such as purification, formulation and fill-finish, impacts yield and production costs, and must be controlled throughout the manufacturing process. Understanding aggregation mechanisms and developing mitigating strategies are imperative to ensure the clinical efficacy of the protein drug product and to reduce costs. This commentary reflects on recent progress made in the field of monoclonal antibody (mAb) aggregation with considerations on current and emerging measurement techniques, the use of novel excipients for preventing aggregation, interfacial phenomena and prediction of aggregation rates. The future direction of research is discussed based on academic and industrial perspectives.

Keywords: Characterisation; Excipients; Interface; Monoclonal antibody; Particle; Protein aggregation; Technologies.