Peer Reviewed Article:
Validating Protein Concentration of Antibody-Drug Conjugates
RESEARCH BRIEF | AUGUST 31 2022
Validating Protein Concentration of Antibody-Drug Conjugates with the CTechTM SoloVPE® System
Nigel Herbert
Sr. Bioanalytics Applications Specialist -
Repligen Corporation
Joshua Das
Scientist I, Analytical Research and Development, Global NBE Analytical R&D -
AbbVie
Priya Patel
Scientist I, Analytical Research and Development, Global NBE Analytical R&D -
AbbVie
Abstract
Antibody-drug conjugates (ADCs) are complex molecules designed to target and kill tumor cells. ADCs consist of a monoclonal antibody, drug linker, and drug (payload), where the antibody generally targets the protein on the tumor cell. UV-Vis spectroscopy is the simplest and most common method to determine protein concentration of ADCs; however, traditional fixed-pathlength spectrophotometers have issues analyzing these complex molecules. The CTechTM SoloVPE® System variable pathlength method, also known as the Slope Spectroscopy® method, offers a more accurate solution. This publication demonstrates how an assay by the SoloVPE method was validated to determine the protein concentration of an ADC. The method was validated by assessing the precision, accuracy, and linearity of the sample. The SoloVPE passed all acceptance criteria seamlessly, proving the technology to be the superior method for this application.
Keywords:
ADC; antibody–drug conjugate; cytotoxic payload; linker; monoclonal antibody; UV-Vis spectroscopy; protein concentration.
How to cite:
Herbert N, Das J, Patel P. Validating Protein Concentration of Antibody-Drug Conjugates with the CTechTM SoloVPE® System – J. ADC. August 31, 2022 . DOI: https://doi.org/10.14229/jadc.2022.08.31.001.
Article History:
Original Manuscript Received: August 1, 2022
Review results received: August 25, 2022
Last Editorial Review: August 29, 2022
Manuscript accepted for publication: August 29, 2020
Conflict of interest statement
The authors declare no conflict of interest.
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© 2022 ADC Review | Journal of Antibody-drug Conjugates
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