ID–MAM: A Validated Identity and Multi-Attribute Monitoring Method for Commercial Release and Stability Testing of a Bispecific Antibody
Author:
Affiliation:
1. BioTherapeutics Development & Supply—Analytical Development, Janssen Research and Development, LLC, Malvern, Pennsylvania 19355, United States
Publisher
American Chemical Society (ACS)
Subject
Analytical Chemistry
Link
https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.1c01029
Reference32 articles.
1. Resolving the micro-heterogeneity and structural integrity of monoclonal antibodies by hybrid mass spectrometric approaches
2. Comprehensive Discovery and Quantitation of Protein Heterogeneity via LC-MS/MS Peptide Mapping for Clone Selection of a Therapeutic Protein
3. Protein heterogeneity and the immunogenicity of biotherapeutics
4. Biosimilar, Biobetter, and Next Generation Antibody Characterization by Mass Spectrometry
5. ICH Harmonised Tripartite. Quality Risk Management Q9. Guidance for Industry; FDA US Food and Drugs, 2005.
Cited by 24 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Multi-attribute monitoring applications in biopharmaceutical analysis;Journal of Chromatography Open;2024-11
2. Comprehensive Stress Stability Studies Reveal the Prominent Stability of the Liquid-Formulated Biotherapeutic Asymmetric Monovalent Bispecific IgG1 Monoclonal Antibody Format;Journal of Pharmaceutical Sciences;2024-08
3. Possibility of using the imaged capillary isoelectric method as a multi‐attribute method for bispecific antibodies;ELECTROPHORESIS;2024-07-08
4. Targeted CQA analytical control strategy for commercial antibody products: Replacing ion-exchange chromatography methods for charge heterogeneity with multi-attribute monitoring;mAbs;2024-04-23
5. Leveraging mass detection to simultaneously quantify surfactant content and degradation mode for highly concentrated biopharmaceuticals;Journal of Pharmaceutical and Biomedical Analysis;2023-11
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3