摘要
原液储存是抗体药物生产过程中的关键步骤。储存过程中影响抗体质量的因素较多,包括抗体分子自身性质、环境应力和储存方式等。冷冻保存是很多抗体分子长期储存的方式,不同冷冻保存方式对药物有不同影响,其中容器是容易被忽视但对药物质量有重要影响的因素。本文通过对比容器的材质如塑料、不锈钢和一次性袋子,可浸出物和可提取物,灭菌方式,及受控速率冷冻和非受控速率冷冻等不同储存方式,旨在为选择高效、低成本、保证质量稳定的抗体原液储存方法提供新思路。
Drug substance storage is a critical step in the production of antibody drugs.There are several factors affecting the quality of antibody in the storage process,including the character of antibody molecule itself,environmental stresses,and storage conditions.One of the common storage conditions for the antibody long⁃term storage is under the freeze condition.However,storage container is easily overlooked although it has major impacts on the quality of drug.This article compares different type of storage containers such as plastic,stainless steel and disposable bags,and their extractable and extractable materials,sterilization methods,and freezing under controlled rate or not for the choice.It also provides an idea of choosing proper condition for the drug substance storage with low cost,efficiency as well as the stable drug quality.
作者
郭欢欢
丁毅
韩玉全
张雅婷
熊菲
纪仁智
GUO Huanhuan;DING Yi;HAN Yuquan;ZHANG Yating;XIONG Fei;JI Renzhi(The Process Development Department of BeiGene(Guangzhou)Biologics Manufacturing Company,Guangzhou,Guangdong 510555,China;Qingdao Huangdao District People’s Hospital,Qingdao,Shandong 266400,China)
出处
《今日药学》
CAS
2023年第4期262-267,共6页
Pharmacy Today
关键词
抗体药物
原液
储存容器
冻融
antibody drug product
drug substance
storage container
freeze thawing
