重组单克隆抗体治疗药物的分析可比性研究。
Analytical comparability study of recombinant monoclonal antibody therapeutics.
机构信息
a Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences , Ocean Ranch Blvd, Oceanside , CA.
b Analytical Research & Development-Biologics, Celgene Corporation , Morris Avenue, Summit , NJ.
出版信息
MAbs. 2018 May/Jun;10(4):513-538. doi: 10.1080/19420862.2018.1438797. Epub 2018 Mar 20.
Abstract
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.
摘要
在重组单克隆抗体治疗药物的生命周期中，工艺变更不可避免。需要通过可比性研究证明使用变更前后工艺生产的产品具有可比性，才有资格进行持续开发和商业供应。可比性的确立是一个系统的过程，基于对产品质量属性与其安全性和疗效之间关系的科学认识和临床经验，收集和评估数据。本文综述了目前对重组单克隆抗体各种修饰的理解，并进一步概述了在产品生命周期的不同阶段设计和执行成功的可比性研究以支持工艺变更的关键步骤。
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