上游工艺对酸碱变异体的调控策略  

Regulation Strategy of Acid-base Variants by Upstream Processes

作　　者：刘晓静 王攀 王晓飞 徐胜楠 林云飞 毛佳琪 李国柱 秦国宏 LIU Xiaojing;WANG Pan;WANG Xiaofei;XU Shengnan;LIN Yunfei;MAO Jiaqi;LI Guozhu;QIN Guohong(Department of Biology,Fanghua Pharmaceutical Research Institute,Nanjing ChiaTai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]南京正大天晴制药有限公司芳华药物研究院生物所,江苏南京210046

出　　处：《山东化工》2024年第21期119-121,125,共4页Shandong Chemical Industry

摘　　要：酸碱变异体作为抗体的关键质量属性,反映了抗体分子的异质性水平、批间一致性等质量特性,对抗体药物的有效性、安全性和稳定性产生影响,因此需对酸碱变异体进行合理的调控,且控制在一定的可接受范围内。对于上游工艺来说,选择电荷异质性低的细胞系尤为重要,其次还可以通过优化培养参数和微调培养基组分以减少酸碱变异体的产生。本文主要阐述导致酸碱变异体形成原因以及基于上游工艺对酸碱变异体的调控策略。As a critical quality attribute of antibodies,acid-base variants are indicative of the heterogeneity level of antibody molecules,batch consistency,and other quality characteristics.They have a significant impact on the efficacy,safety,and stability of antibody drugs.Therefore,it is essential to regulate and control acid-base variants within an acceptable range.For upstream processes,the selection of cell lines with low charge heterogeneity is particularly crucial.Additionally,optimizing culture parameters and fine-tuning medium components can also help reduce the generation of acid-base variants.This paper discusses the reasons for the formation of acid-base variants and regulatory strategies based on upstream processes.

关 键 词：翻译后修饰 酸碱变异体 上游工艺 培养基组分 

分 类 号：TQ114[化学工程—无机化工] Q813.11[生物学—生物工程]