Innovative Use of LC-MS/MS for Simultaneous Quantitation of Neutralizing Antibody, Residual Drug, and Human Immunoglobulin G in Immunogenicity Assay Development-Reference-Cited by-同舟云学术

Innovative Use of LC-MS/MS for Simultaneous Quantitation of Neutralizing Antibody, Residual Drug, and Human Immunoglobulin G in Immunogenicity Assay Development

Published:2014-02-17 Issue:5 Volume:86 Page:2673-2680
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Jiang Hao¹,Xu Weifeng¹,Titsch Craig A.¹,Furlong Michael T.¹,Dodge Robert¹,Voronin Kimberly¹,Allentoff Alban¹,Zeng Jianing¹,Aubry Anne-Françoise¹,DeSilva Binodh S.¹,Arnold Mark E.¹

Affiliation:

1. Analytical and Bioanalytical Development and ‡ Discovery Chemistry Synthesis, Bristol-Myers Squibb, Princeton, New Jersey 08540, United States

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/ac5001465

Reference16 articles.

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2. The effect of neutralizing antibodies on the sustainable efficacy of biologic therapies: what’s in it for African and Middle Eastern rheumatologists

3. Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (Draft).U.S. Food and Drug Administration, February 2013.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf(accessed September 21, 2013) .

4. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (Draft).U.S. Food and Drug Administration, December 2009.http://www.fda.gov/downloads/Drugs/./Guidances/UCM192750.pdf(accessed September 21, 2013) .

5. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

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