Analytical comparability study of recombinant monoclonal antibody therapeutics
Analytical comparability study of recombinant monoclonal antibody therapeutics
复制标题
DOI：
10.1080/19420862.2018.1438797
复制
发表时间：
2018-01-01
期刊：
影响因子：
5.3
通讯作者：
Liu, Hongcheng
中科院分区：
文献类型：
--
作者：
Ambrogelly, Alexandre;Gozo, Stephen;Liu, Hongcheng
在重组单克隆抗体治疗剂的生命周期中，工艺变化是不可避免的。要求采用变更前和变更后工艺生产的产品具有可比性，如可比性研究所证明，以符合持续开发和商业供应的要求。可比性的建立是一个基于对产品质量属性之间关系及其对安全性和有效性影响的科学理解和临床经验收集和评价数据的系统过程。本文综述了目前对重组单克隆抗体的各种修饰。它进一步概述了设计和执行成功的可比性研究的关键步骤，以支持产品生命周期不同阶段的工艺变更。
Process changes are inevitable in the life cycle of recombinant monoclonal antibody therapeutics. Products made using pre- and post-change processes are required to be comparable as demonstrated by comparability studies to qualify for continuous development and commercial supply. Establishment of comparability is a systematic process of gathering and evaluating data based on scientific understanding and clinical experience of the relationship between product quality attributes and their impact on safety and efficacy. This review summarizes the current understanding of various modifications of recombinant monoclonal antibodies. It further outlines the critical steps in designing and executing successful comparability studies to support process changes at different stages of a product's lifecycle.