Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Int J Pharm. 2018 Dec 1;552(1-2):1-6. doi: 10.1016/j.ijpharm.2018.09.049. Epub 2018 Sep 22.
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.
在生物处理步骤（如纯化、制剂和灌装）过程中，蛋白质聚集的发生会影响产量和生产成本，因此必须在整个制造过程中加以控制。了解聚集机制并开发缓解策略对于确保蛋白质药物产品的临床疗效和降低成本至关重要。本文述评了单克隆抗体（mAb）聚集领域的最新进展，考虑了当前和新兴的测量技术、新型赋形剂在防止聚集方面的应用、界面现象和聚集速率的预测。基于学术和工业的角度讨论了未来的研究方向。
