MPA on track to become the first NAM approved by the FDA for specificity testing
PHILADELPHIA, Oct. 28, 2025 /PRNewswire/ — Integral Molecular, a leader in antibody discovery and characterization, announces that its Membrane Proteome Array™ (MPA) used to assess antibody specificity is entering its final stage of FDA review to become a Drug Development Tool (DDT). This follows Integral Molecular’s submission of a Full Qualification Package (FQP) to the FDA.
The MPA is a fully validated New Approach Methodology (NAM) that assesses therapeutic antibodies in a human-relevant, cell-based system prior to clinical studies, aligning with the FDA’s vision to accelerate the use of in vitro assays that better predict drug safety. This cell-based protein array (CBPA) is the only platform that measures antibody binding to human membrane proteins in their structurally intact, native conformation in a quantitative and comprehensive manner across ~6,000 proteins in the membrane proteome, enabling early identification of off-target interactions that can impact safety. Off-target assessment of therapeutic antibodies is a critical preclinical safety requirement, especially with evidence showing that 1 in 3 monoclonal antibodies exhibit off-target binding.1
Learn more about the Membrane Proteome Array™
, a fully validated New Approach Methodology (NAM) to test antibody specificity.
Collaboration With FDA Drives Key Improvements
Working closely with the FDA, Integral Molecular is making key enhancements to the MPA platform that include:
- Expanded MPA library encompassing fetal and maternal proteins, heterocomplexes, and secreted proteins
- Statistical analysis of protein interactions to rigorously evaluate levels of off-target binding
- Bioinformatic assessment to interpret the biological ramifications of off-target binding in tissues
- ISO 9001 certification of the company’s quality management system, with enhanced 21 CFR Part 11-compliant record-keeping
“The MPA is used by over 250 biopharmaceutical companies to test the specificity of therapeutic antibodies, helping ensure they target only their intended proteins,” said Benjamin Doranz, CEO of Integral Molecular. “While MPA data are already routinely included in regulatory submissions, including over 100 INDs, formal qualification as a DDT will streamline regulatory review.”
The MPA is progressing toward DDT qualification as the first technology reviewed under the FDA’s ISTAND Program (Innovative Science and Technology Approaches for New Drugs). Submission of the Full Qualification Package marks the final step in the process and represents an important milestone towards establishing this NAM-based antibody specificity testing method as a regulatory standard.
1 Norden et al. mAbs. 2024. doi:10.1080/19420862.2024.2393785.
About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 600 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.
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Press Contact
Integral Molecular
Soma Banik, PhD, Director of Public Relations
215-966-6061
[email protected]
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SOURCE Integral Molecular
