Integral Molecular announced that the FDA has accepted their Membrane Proteome Array™ (MPA) Qualification Plan for advancement as a Drug Development Tool (DDT) to assess antibody binding specificity. Antibody drug developers already routinely include MPA data in regulatory packages, and qualification as a DDT will allow them to further rely on the MPA in the approval process.
Non-specific drug binding is a significant cause of adverse events in patients that can lead to severe complications or even death, and early specificity testing can de-risk drug development and enhance patient safety. Recent research has demonstrated that up to one-third of antibody drugs exhibit non-specific binding to unintended targets.
The MPA assesses binding across ~6,000 structurally intact membrane proteins and is the only platform of its kind that screens membrane proteins in their native conformation. The MPA has been used to screen over 2,000 preclinical antibody therapeutics for customers worldwide, and MPA specificity data has been accepted by regulatory bodies globally, including the FDA, EMA, and NMPA.
"This milestone towards MPA qualification reflects the continued dedication of our team to set a new standard in testing antibody drug specificity. Our continued improvements to the MPA—including statistical analyses, bioinformatic comparisons, and enhanced quality systems—have been critical to our qualification plan and have supported ISO 9001 certification of our processes. We thank the FDA for their confidence in our approach and commitment to advancing the safety of biologics."Benjamin Doranz, CEO, Integral Molecular
The MPA is progressing toward DDT qualification under the FDA's ISTAND Pilot Program, which promotes Innovative Science and Technology Approaches for New Drugs. As part of this process, Integral Molecular has been invited to submit a Full Qualification Plan (FQP) for the MPA, which is the final step in achieving DDT status.
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