In this free webinar, gain insights into the complexity, comprehensive strategy and regulatory considerations for bioanalysis in support of the development of drug-conjugated antibody (ADC). A case example will be presented for developing and validating a panel of liquid chromatography-mass spectrometry (LC-MS) pharmacokinetics (PK) assays: free drugs (payloads), drug-conjugated antibody (intact ADC) and total antibody. Attendees will learn bioanalytical strategies for ADC drug development and how to apply the PK assay results to inform on ADC stability and dose selection.
TORONTO, Oct. 24, 2023 /PRNewswire-PRWeb/ — Discover a groundbreaking webinar delving into bioanalytical complexity, strategy and regulatory considerations when developing ADC therapeutics with a focus on developing and validating liquid chromatography-mass spectrometry (LC-MS) pharmacokinetics (PK) assays.
Antibody-drug conjugates are a new and fast-growing class of targeted drugs consisting of “antibodies, cytotoxic drugs and linkers”. The antibody-drug conjugates are designed to increase the specificity and reduce the toxicity of cytotoxic drugs by utilizing antibodies to deliver the drug specifically to target cells (e.g., tumor cells) while avoiding toxicity in healthy cells. Design of a comprehensive bioanalytical strategy is critical to enable successful regulatory approval.
Understanding the PK profile of antibody-drug conjugates in pre-clinical and clinical studies is a regulatory expectation. Due to the complexity of ADC molecules, there are several analytes that need to be quantified to characterize ADC PK profiles, including free drugs (payloads), drug-conjugated antibodies (intact ADC) and total antibody. Amador Biosciences will share a case study demonstrating the successful development and validation of LC-MS methods for all three analytes.
Join this webinar to gain insights into bioanalytical considerations for ADC development and to learn how to develop and validate LC-MS PK assays which are used to generate data to inform stability and dose selection.
Join experts from Amador Bioscience, Meina Liang, Chief Technology Officer (CTO), President of Bioanalysis & Biomarkers; and Andrea Ngai, Associate Director, Bioanalysis & Biomarkers, for the live webinar on Wednesday, November 8, 2023, at 12pm EST (9am PST).
For more information, or to register for this event, visit Quantitative Bioanalysis of Antibody-Drug Conjugates by Mass Spectrometry.
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