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Specificity Testing of Antibody and CAR-T Cell Therapies for IND Using the Membrane Proteome Array


Rigorous specificity analysis is critical for successful drug development and a safety requirement for antibody-based therapies, such as CAR-T, entering IND. Tissue cross-reactivity (TCR) studies have been traditionally used to screen for off-target binding; however, their predictive value for in vivo safety and toxicity is poor. Integral Molecular has developed the Membrane Proteome Array (MPA) platform to de-risk antibody-based therapeutics by testing specificity across the full human membrane proteome expressed in live cells. Using sensitive high-throughput flow cytometry to identify binding interactions on a protein level, this technology has emerged as the leading solution for antibody specificity profiling. 

In this GEN webinar, the panelists discuss their experiences using the MPA to rapidly identify potential off-target interactions, resulting in successful IND filings for CAR-T cell therapies where conventional approaches did not suffice. They also describe the newest additions to this 6,000-protein cell array and the status of its consideration by the FDA as a qualified Drug Development Tool.

Video contents

Jonathan Grinstein, PhD, Senior Editor; Genetic Engineering & Biotechnology News

Rachel Fong, Director of Sales and Alliances, Integral Molecular

Rachel introduces the MPA and describes how this industry-leading tool can be used for specificity testing across various applications, with a focus on lead selection and IND submissions.

Darshil Patel, PhD, Associate Director, Preclinical Research; Cabaletta Bio

Dr. Patel describes his team’s experience using the MPA to de-risk multiple therapeutic candidates. He highlights two CAAR T product candidates, targeting DSG3 and MuSK, designed to selectively and specifically eliminate pathogenic B cells.

Donald Siegel, PhD, MD, Professor of Pathology & Laboratory Medicine; Director, Division of Transfusion Medicine & Therapeutic Pathology; Director, Center for Advanced Cellular Therapies; Perelman School of Medicine, University of Pennsylvania

Dr. Siegel shares the story that inspired his team to develop a CAR T-cell therapy targeting GFR𝛼4, a specific marker for medullary thyroid cancer, now in clinical trials. He describes the critical role MPA data played in both lead selection and IND filing.

Related publications

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