Antibody-drug conjugate bioanalysis using LB-LC-MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays.

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Abstract

Antibody-drug conjugates (ADCs) are complex drug constructs with multiple species in the heterogeneous mixture that contribute to their efficacy and toxicity. The bioanalysis of ADCs involves multiple assays and analytical platforms.

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Journal

Journal ID (iso-abbrev): Bioanalysis

Title: Bioanalysis

Publisher: Future Science, LTD

ISSN (Electronic): 1757-6199

ISSN (Print): 1757-6180

Publication date (Electronic): Jul 2016

Volume: 8

Issue: 13

Affiliations

[1 ] Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

[2 ] Biologics Discovery California, Bristol-Myers Squibb, Redwood City, CA 95035, USA.

[3 ] Preclinical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

[4 ] Drug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, NJ 08903, USA.

[5 ] Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

Article

DOI: 10.4155/bio-2016-0017

PubMed ID: 27277879

SO-VID: 5f059625-d383-4cc4-8319-54d760f23f92

History

Keywords: DAR-bias,immunocapture LC–MS/MS hybrid assay,ligand binding-LC–MS/MS hybrid assay,soluble target,antibody conjugated-payload,drug antibody ratio,fit-for-purpose bioanalysis,generic reagents,antibody–drug conjugate,DAR-sensitive ADC assay

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Keywords: DAR-bias, immunocapture LC–MS/MS hybrid assay, ligand binding-LC–MS/MS hybrid assay, soluble target, antibody conjugated-payload, drug antibody ratio, fit-for-purpose bioanalysis, generic reagents, antibody–drug conjugate, DAR-sensitive ADC assay

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