ADCs
Expert bioanalytical testing for antibody-drug conjugates (ADCs)
Within bioanalytical testing, ADCs present unique challenges due to their complex structure, which includes multiple components: antibody, linker, and payload. Assessing the stability, efficacy, and safety of ADCs requires specialised analytical strategies that can evaluate each component individually and the ADC as a whole.
Bioanalytical testing for ADCs typically involves ligand-binding assays (LBAs) and liquid chromatography-mass spectrometry (LC-MS) to measure critical parameters such as drug-to-antibody ratio (DAR), free payload levels, and total antibody concentration. Immunogenicity assessments are also crucial, as anti-ADC antibodies may impact drug efficacy and patient safety. These comprehensive bioanalytical approaches are essential for regulatory approval and optimizing ADC therapeutic performance.
ICON’s bioanalytical laboratories have significant experience with ADC bioanalysis. We have been doing this type of bioanalysis since 2013 and have supported many different drug development programs for multiple sponsors. With an integrated approach we streamline the assays between the different technologies and departments that are typically involved.
Finding your way in ADC bioanalytics
In this paper we highlight some of the challenges of typical bioanalytical ADC assays and provide insights into possible approaches for designing a bioanalytical strategy to support ADC drug development.
Challenges and advances in payload analysis for antibody drug conjugates: A CRO perspective
By 2024, 15 ADCs had received approval, with over 100 more in clinical trials. As this growing interest permeates through the pharmaceutical sector, CROs are increasingly involved in the clinical trials of new ADCs.
Strategies for ADC bioanalysis
During this webinar hosted by Bioanalysis Zone, ICON's experts discussed the complexities of ADC assays and how they can be best optimised.
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