Pfizer Inc., Global Biologics, 700 Chesterfield Parkway West, Chesterfield, MO 63017, United States.
Int J Pharm. 2010 May 10;390(2):89-99. doi: 10.1016/j.ijpharm.2010.02.025. Epub 2010 Feb 24.
Proteins generally will tend to aggregate under a variety of environmental conditions in comparison with small drug molecules. The extent of aggregation is dependent on many factors that can be broadly classified as intrinsic (primary, secondary, tertiary or quaternary structure) or extrinsic (environment in which protein is present, processing conditions, etc). These protein aggregates may exhibit less desirable characteristics like reduced or no biological activity, potential for immunogenicity or other side effects. Protein aggregation remains one of the major challenges in the development and commercialization of biotechnology products. This article is intended to review and discuss the latest understandings in protein aggregation pathways and the possible extrinsic factors that affect or control the protein aggregation process.
与小分子药物相比，蛋白质在各种环境条件下通常更容易聚集。聚集的程度取决于许多因素，可以广义地分为内在因素（一级、二级、三级或四级结构）或外在因素（蛋白质存在的环境、加工条件等）。这些蛋白质聚集体可能表现出不理想的特性，如生物活性降低或丧失、免疫原性或其他副作用的潜力。蛋白质聚集仍然是生物技术产品开发和商业化的主要挑战之一。本文旨在综述和讨论蛋白质聚集途径的最新认识，以及可能影响或控制蛋白质聚集过程的外在因素。
