Institutes of Health Central Plains, Xinxiang Medical University, Xinxiang, China.
Henan International Joint Laboratory of Recombinant Pharmaceutical Protein Expression System, Xinxiang Medical University, Xinxiang, China.
Curr Pharm Biotechnol. 2024;25(6):665-675. doi: 10.2174/1389201024666230818112633.
Chinese hamster ovary cells are the main expression system for recombinant therapeutic proteins. During the production of these proteins, certain host cell proteins are secreted, broken down, and released by host cells in the culture along with the proteins of interest. These host cell proteins are often difficult to remove during the downstream purification process, and thus affect the quality, safety, and effectiveness of recombinant protein biopharmaceutical products and increase the production cost of recombinant therapeutic proteins. Therefore, host cell protein production must be reduced as much as possible during the production process and eliminated during purification. This article reviews the harm caused by host cell proteins in the production of recombinant protein drugs using Chinese hamster ovary cell, factors affecting host cell proteins, the monitoring and identification of these proteins, and methods to reduce their type and quantity in the final product.
中国仓鼠卵巢细胞是重组治疗性蛋白的主要表达系统。在这些蛋白的生产过程中，某些宿主细胞蛋白会在培养过程中被宿主细胞分泌、降解并释放出来，与感兴趣的蛋白一起释放。这些宿主细胞蛋白在下游纯化过程中往往难以去除，从而影响重组蛋白生物制药产品的质量、安全性和有效性，并增加重组治疗性蛋白的生产成本。因此，在生产过程中必须尽可能减少宿主细胞蛋白的产生，并在纯化过程中去除。本文综述了中国仓鼠卵巢细胞生产重组蛋白药物时宿主细胞蛋白造成的危害、影响宿主细胞蛋白的因素、这些蛋白的监测和鉴定方法，以及降低最终产品中宿主细胞蛋白种类和数量的方法。
