A Robust Purity Method for Biotherapeutics Using New Peak Detection in an LC–MS-Based Multi-Attribute Method
Author:
Affiliation:
1. Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, California 94080, United States
Publisher
American Chemical Society (ACS)
Subject
Spectroscopy,Structural Biology
Link
https://pubs.acs.org/doi/pdf/10.1021/jasms.2c00355
Reference41 articles.
1. Development of therapeutic antibodies for the treatment of diseases
2. Recent advances in LC–MS based characterization of protein-based bio-therapeutics – mastering analytical challenges posed by the increasing format complexity
3. A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy
4. Recent advancements, challenges, and practical considerations in the mass spectrometry-based analytics of protein biotherapeutics: A viewpoint from the biosimilar industry
5. Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product
Cited by 6 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. Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory;European Journal of Pharmaceutics and Biopharmaceutics;2023-10
2. Expanding the Analytical Toolbox: Developing New Lys-C Peptide Mapping Methods with Minimized Assay-Induced Artifacts to Fully Characterize Antibodies;Pharmaceuticals;2023-09-20
3. Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release and cGMP Purity Testing at the Peptide and Intact Protein Level;Critical Reviews in Analytical Chemistry;2023-07-25
4. Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory;European Journal of Pharmaceutics and Biopharmaceutics;2023-07
5. Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control;mAbs;2023-04-14
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