Development of a Cell-based Neutralizing Antibody Assay for Zinpentraxin Alfa: Challenges and Mitigation Strategies
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
https://link.springer.com/content/pdf/10.1208/s12248-023-00841-2.pdf
Reference51 articles.
1. Boehncke WH, Brembilla NC. Immunogenicity of biologic therapies: causes and consequences. Expert Rev Clin Immunol. 2018;14(6):513–23. https://doi.org/10.1080/1744666X.2018.1468753.
2. Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction. Curr Pharm Biotechnol. 2002;3(4):349–60. https://doi.org/10.2174/1389201023378175.
3. Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol. 2007;25(5):555–61. https://doi.org/10.1038/nbt1303.
4. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48(5):1267–81. https://doi.org/10.1016/j.jpba.2008.09.020.
5. Gunn GR 3rd, Sealey DC, Jamali F, Meibohm B, Ghosh S, Shankar G. From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals. Clin Exp Immunol. 2016;184(2):137–46. https://doi.org/10.1111/cei.12742.
Cited by 1 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. Highly drug/target-tolerant neutralizing antibody (NAb) assay development through target-based drug depletion and drug-based NAb extraction for an anti-EGFR therapeutic monoclonal antibody;Journal of Pharmaceutical and Biomedical Analysis;2024-04
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