Protein aggregation – Mechanisms, detection, and control

Abstract

Protein aggregation has been recognized as one of the major challenges in the development and commercialization of successful protein-based drug products because of the inherent and high aggregation tendency during various manufacturing processes, storage, and administration. Protein aggregates may impact significantly the product quality, safety and/or efficacy. This review is intended to summarize four major aspects of protein aggregation – (1) aggregation mechanisms, (2) aggregation-influencing factors, (3) detection of protein aggregates, and (4) control of protein aggregation based on recent literature in this area.