Integral Molecular’s Membrane Proteome Array Progresses Towards FDA Qualification
The MPA is on track to be the first NAM approved by the FDA for specificity testing.
Integral Molecular, recognized as a frontrunner in antibody discovery and characterization, is excited to announce that its Membrane Proteome Array™ (MPA) is nearing the final stages of FDA review to become a Drug Development Tool (DDT). This significant milestone follows the submission of a Full Qualification Package (FQP) to the FDA.
The Membrane Proteome Array is a comprehensive New Approach Methodology (NAM) designed to evaluate therapeutic antibodies within human-relevant, cell-based systems before they enter clinical trials. This aligns with the FDA’s commitment to accelerate the adoption of in vitro assays that enhance drug safety predictions. The MPA platform uniquely measures antibody interactions with human membrane proteins, maintaining their native structural integrity. This meticulous process analyzes roughly 6,000 proteins within the membrane proteome, facilitating the early detection of unintended interactions that could pose safety risks.
Assessing off-target interactions among therapeutic antibodies is paramount, especially in light of findings indicating that approximately one in three monoclonal antibodies may exhibit such unintended binding activities. These assessments are essential for ensuring safety in preclinical testing.
Key Enhancements Through Collaboration with the FDA
Integral Molecular has engaged in fruitful collaboration with the FDA, leading to pivotal advancements within the MPA platform. These enhancements include:
Expanded Protein Library
The MPA now features an expanded library that includes fetal and maternal proteins, heterocomplexes, and secreted proteins, providing a more comprehensive dataset for antibody assessment.
Statistical Analysis Enhancements
Robust statistical analysis techniques have been implemented to meticulously evaluate off-target binding levels. This analytical depth ensures more accurate evaluations of antibody specificity.
Bioinformatic Assessments
New bioinformatic assessment tools are utilized to interpret the biological implications of off-target binding in human tissues. This advancement strengthens the understanding of therapeutic antibodies' interactions within the body.
Quality Management Certifications
Integral Molecular’s quality management system has achieved ISO 9001 certification, with measures in place to comply with enhanced 21 CFR Part 11 record-keeping requirements.
As stated by Benjamin Doranz, CEO of Integral Molecular, "The MPA is indispensable for over 250 biopharmaceutical companies, helping them ensure that therapeutic antibodies specifically target their intended proteins. Although MPA data routinely play a role in regulatory submissions—including over 100 INDs—formal qualification as a DDT will vastly streamline the regulatory review process."
The MPA is advancing towards DDT qualification as a pioneer technology under the FDA’s ISTAND Program, aimed at fostering Innovative Science and Technology Approaches for New Drugs. The submission of the Full Qualification Package signifies a critical step in establishing this NAM-based method for testing antibody specificity as a regulatory standard in the industry.
About Integral Molecular
Integral Molecular (integralmolecular.com) is a leading innovator focused on creating transformative technologies that enhance the discovery of therapeutics against challenging protein targets. With over 20 years of expertise in membrane proteins, viruses, and antibodies, Integral Molecular has integrated its technologies into the drug discovery workflows of more than 600 biotechnology and pharmaceutical firms, advancing the development of therapies for a range of conditions, including cancer, diabetes, autoimmune diseases, as well as viral threats such as SARS-CoV-2, Ebola, Zika, and dengue.
Contact Information
Integral Molecular
Soma Banik, PhD, Director of Public Relations
215-966-6061
Frequently Asked Questions
What is the purpose of the Membrane Proteome Array?
The Membrane Proteome Array is designed to assess the specificity of therapeutic antibodies in a human-relevant cell-based system before clinical trials.
How does the MPA help in drug development?
The MPA enhances drug development by identifying off-target interactions early, which helps to ensure the safety of therapeutic antibodies.
Why is FDA qualification important for the MPA?
FDA qualification as a Drug Development Tool will streamline regulatory reviews, facilitating faster approval processes for new therapies.
What advancements has Integral Molecular made in the MPA?
Integral Molecular has enhanced the MPA through expanded libraries, statistical analyses, bioinformatic assessments, and quality management system certifications.
How many companies utilize the MPA?
Over 250 biopharmaceutical companies currently use the MPA to validate the specificity of their therapeutic antibodies.
