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.

在重组单克隆抗体疗法的生命周期中，工艺变化是不可避免的。使用变更前和变更后工艺生产的产品需要具有可比性，如可比性研究所证明的那样，才有资格进行持续开发和商业供应。可比性的建立是基于对产品质量属性及其对安全性和有效性的影响之间关系的科学理解和临床经验来收集和评估数据的系统过程。本综述总结了目前对重组单克隆抗体各种修饰的理解。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流程变更。