Current Analytical Strategies for Antibody-Drug Conjugates in Biomatrices

Antibody-drug conjugates (ADCs) are a new class of biotherapeutics, consisting of a cytotoxic payload covalently bound to an antibody by a linker. Ligand-binding assay (LBA) and liquid chromatography-mass spectrometry (LC-MS) are the favored techniques for the analysis of ADCs in biomatrices. The go...

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Bibliographic Details
Published in:Molecules (Basel, Switzerland) Switzerland), 2022-09, Vol.27 (19), p.6299
Main Authors: Qin, Qiuping, Gong, Likun
Format: Article
Language:English
Subjects:
ADC
Antibodies
antibody
Antigens
Assaying
bioanalysis
Biopharmaceutics
Cancer therapies
Chromatography, Liquid - methods
Comparative analysis
Conjugates
Cytotoxicity
Immunoconjugates
Immunogenicity
LBA
LC–MS
Ligands
Liquid chromatography
Liu, Timothy
Mass spectrometry
Mass Spectrometry - methods
Mass spectroscopy
Monoclonal antibodies
payload
Payloads
Pharmacokinetics
Proteins
Reagents
Review
Viral antibodies
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Summary:Antibody-drug conjugates (ADCs) are a new class of biotherapeutics, consisting of a cytotoxic payload covalently bound to an antibody by a linker. Ligand-binding assay (LBA) and liquid chromatography-mass spectrometry (LC-MS) are the favored techniques for the analysis of ADCs in biomatrices. The goal of our review is to provide current strategies related to a series of bioanalytical assays for pharmacokinetics (PK) and anti-drug antibody (ADA) assessments. Furthermore, the strengths and limitations of LBA and LC-MS platforms are compared. Finally, potential factors that affect the performance of the developed assays are also provided. It is hoped that the review can provide valuable insights to bioanalytical scientists on the use of an integrated analytical strategy involving LBA and LC-MS for the bioanalysis of ADCs and related immunogenicity evaluation.
ISSN:1420-3049
1420-3049
DOI:10.3390/molecules27196299