Commentary: New perspectives on protein aggregation during Biopharmaceutical development.

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