Ambrogelly Alexandre
Pharmaceutical and Biologics Operations, Gilead Sciences, 4010 Ocean Ranch Blvd, Oceanside, CA 92056, USA.
Antibodies (Basel). 2021 May 24;10(2):21. doi: 10.3390/antib10020021.
The color of a therapeutic monoclonal antibody solution is a critical quality attribute. Consistency of color is typically assessed at time of release and during stability studies against preset criteria for late stage clinical and commercial products. A therapeutic protein solution's color may be determined by visual inspection or by more quantitative methods as per the different geographical area compendia. The nature and intensity of the color of a therapeutic protein solution is typically determined relative to calibrated standards. This review covers the analytical methodologies used for determining the color of a protein solution and presents an overview of protein variants and impurities known to contribute to colored recombinant therapeutic protein solutions.
治疗性单克隆抗体溶液的颜色是一项关键的质量属性。对于晚期临床和商业产品，通常在放行时以及稳定性研究期间对照预设标准评估颜色的一致性。治疗性蛋白质溶液的颜色可通过目视检查或根据不同地理区域的药典采用更定量的方法来确定。治疗性蛋白质溶液颜色的性质和强度通常相对于校准标准来确定。本综述涵盖了用于测定蛋白质溶液颜色的分析方法，并概述了已知会导致重组治疗性蛋白质溶液产生颜色的蛋白质变体和杂质。
