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本文引用的文献

1
Forced degradation of recombinant monoclonal antibodies: A practical guide.重组单克隆抗体的强制降解：实用指南。
MAbs. 2017 Nov/Dec;9(8):1217-1230. doi: 10.1080/19420862.2017.1368602. Epub 2017 Aug 30.
2
A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins.基于四极杆质量数的多属性方法用于治疗性蛋白的产品表征、工艺开发和质量控制。
MAbs. 2017 Oct;9(7):1186-1196. doi: 10.1080/19420862.2017.1364326. Epub 2017 Aug 14.
3
Comparison of SEC and CE-SDS methods for monitoring hinge fragmentation in IgG1 monoclonal antibodies.用于监测IgG1单克隆抗体铰链区片段化的尺寸排阻色谱法（SEC）和毛细管电泳-十二烷基硫酸钠聚丙烯酰胺凝胶电泳法（CE-SDS）的比较
J Pharm Biomed Anal. 2017 Oct 25;145:91-97. doi: 10.1016/j.jpba.2017.06.006. Epub 2017 Jun 17.
4
Discovery and Characterization of Histidine Oxidation Initiated Cross-links in an IgG1 Monoclonal Antibody.组氨酸氧化引发的 IgG1 单克隆抗体中交联的发现和表征。
Anal Chem. 2017 Aug 1;89(15):7915-7923. doi: 10.1021/acs.analchem.7b00860. Epub 2017 Jul 10.
5
N-terminal or signal peptide sequence engineering prevents truncation of human monoclonal antibody light chains.N端或信号肽序列工程可防止人单克隆抗体轻链的截短。
Biotechnol Bioeng. 2017 Sep;114(9):1970-1977. doi: 10.1002/bit.26301. Epub 2017 May 8.
6
A Multidimensional Analytical Comparison of Remicade and the Biosimilar Remsima.类克与雷莫西尤单抗生物类似药的多维分析比较。
Anal Chem. 2017 May 2;89(9):4838-4846. doi: 10.1021/acs.analchem.6b04436. Epub 2017 Apr 17.
7
Identification and characterization of monoclonal antibody fragments cleaved at the complementarity determining region using orthogonal analytical methods.使用正交分析方法鉴定和表征在互补决定区裂解的单克隆抗体片段。
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Mar 24;1048:121-129. doi: 10.1016/j.jchromb.2017.02.019. Epub 2017 Feb 21.
8
Establishment and validation of a microfluidic capillary gel electrophoresis platform method for purity analysis of therapeutic monoclonal antibodies.用于治疗性单克隆抗体纯度分析的微流控毛细管凝胶电泳平台方法的建立与验证
Electrophoresis. 2017 May;38(9-10):1353-1365. doi: 10.1002/elps.201600519. Epub 2017 Apr 6.
9
Characterization and QC of biopharmaceuticals by MS-based 'multi-attribute method': advantages and challenges.基于质谱的“多属性方法”对生物制药的表征与质量控制：优势与挑战
Bioanalysis. 2017 Mar;9(6):499-502. doi: 10.4155/bio-2017-0004. Epub 2017 Feb 16.
10
Evaluation of heavy chain C-terminal deletions on productivity and product quality of monoclonal antibodies in Chinese hamster ovary (CHO) cells.中国仓鼠卵巢（CHO）细胞中重链C末端缺失对单克隆抗体生产力和产品质量的评估。
Biotechnol Prog. 2017 May;33(3):786-794. doi: 10.1002/btpr.2444. Epub 2017 Mar 24.

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.

DOI:10.1080/19420862.2018.1438797
PMID:29513619
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5973765/
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。