Integral Molecular's Membrane Proteome Array Advances Toward FDA Qualification
Integral Molecular, a prominent figure in antibody discovery and characterization, is making significant strides with its Membrane Proteome Array™ (MPA). Following the submission of a Full Qualification Package (FQP) to the FDA, the MPA is currently undergoing its final review stage to become a Drug Development Tool (DDT). This development represents a major milestone for Integral Molecular, as the MPA aims to become the first New Approach Methodology (NAM) approved by the FDA specifically for assessing the specificity of therapeutic antibodies.
The Membrane Proteome Array™ is a pioneering tool used to evaluate therapeutic antibodies within a human-relevant, cell-based system. This approach aligns with the FDA's emphasis on accelerating the adoption of in vitro assays that effectively predict drug safety outcomes. The MPA stands out as the only platform capable of quantitatively and comprehensively measuring antibody interactions with human membrane proteins in their native conformations. This unique capability allows researchers to analyze approximately 6,000 proteins within the membrane proteome, providing valuable insights into early identification of off-target interactions that could have safety implications.
Recent data reveals that about one in three monoclonal antibodies display off-target binding behavior, thus underscoring the importance of off-target assessments as a critical safety requirement during the preclinical phase of drug development. Integral Molecular's MPA technology has already been adopted by over 250 biopharmaceutical companies, proving its effectiveness in ensuring therapeutic antibodies accurately target intended proteins. Furthermore, data generated from the MPA have been routinely integrated into regulatory submissions, including over 100 Investigational New Drug (IND) applications.
In collaboration with the FDA, Integral Molecular is enhancing the MPA platform through several key improvements. These updates include an expanded MPA library that incorporates fetal and maternal proteins, heterocomplexes, and secreted proteins, allowing for a more extensive evaluation of off-target binding. Additionally, statistical analyses of protein interactions will provide a rigorous assessment of binding levels, while bioinformatics and advanced analytical techniques will help interpret the biological implications of off-target interactions in various tissues.
Another pivotal upgrade involves achieving ISO 9001 certification of the company's quality management system, which now incorporates enhanced record-keeping practices compliant with 21 CFR Part 11 regulations. These enhancements reflect Integral Molecular’s commitment to maintaining a robust and compliant research environment.
Benjamin Doranz, CEO of Integral Molecular, highlighted the significance of the MPA technology: "The MPA is essential for testing the specificity of therapeutic antibodies, which ensures they engage with their target proteins effectively. While data generated from MPAs has been routinely included in regulatory submissions, achieving formal qualification as a DDT will significantly streamline the review process by regulatory bodies."
The current trajectory of the MPA is particularly notable as it is set to be one of the first technologies assessed under the FDA's ISTAND Program (Innovative Science and Technology Approaches for New Drugs). The submission of the Full Qualification Package marks the final stage in the qualification process. It showcases Integral Molecular's commitment to establishing its NAM-based antibody specificity testing method as a regulatory standard.
Integral Molecular has been recognized for over two decades as a leader in creating transformative technologies that facilitate therapeutic discoveries against challenging protein targets. Their innovative approaches have been instrumental in the drug discovery efforts of more than 600 biotech and pharmaceutical companies, helping to develop therapies for various health conditions, including cancer, diabetes, autoimmune disorders, and viral infections such as SARS-CoV-2, Ebola, Zika, and dengue viruses. As the MPA progresses towards FDA qualification, it signifies a significant advancement in the methodology of antibody specificity testing, paving the way for more effective therapeutic interventions in the future.
The Membrane Proteome Array™ is a pioneering tool used to evaluate therapeutic antibodies within a human-relevant, cell-based system. This approach aligns with the FDA's emphasis on accelerating the adoption of in vitro assays that effectively predict drug safety outcomes. The MPA stands out as the only platform capable of quantitatively and comprehensively measuring antibody interactions with human membrane proteins in their native conformations. This unique capability allows researchers to analyze approximately 6,000 proteins within the membrane proteome, providing valuable insights into early identification of off-target interactions that could have safety implications.
Recent data reveals that about one in three monoclonal antibodies display off-target binding behavior, thus underscoring the importance of off-target assessments as a critical safety requirement during the preclinical phase of drug development. Integral Molecular's MPA technology has already been adopted by over 250 biopharmaceutical companies, proving its effectiveness in ensuring therapeutic antibodies accurately target intended proteins. Furthermore, data generated from the MPA have been routinely integrated into regulatory submissions, including over 100 Investigational New Drug (IND) applications.
In collaboration with the FDA, Integral Molecular is enhancing the MPA platform through several key improvements. These updates include an expanded MPA library that incorporates fetal and maternal proteins, heterocomplexes, and secreted proteins, allowing for a more extensive evaluation of off-target binding. Additionally, statistical analyses of protein interactions will provide a rigorous assessment of binding levels, while bioinformatics and advanced analytical techniques will help interpret the biological implications of off-target interactions in various tissues.
Another pivotal upgrade involves achieving ISO 9001 certification of the company's quality management system, which now incorporates enhanced record-keeping practices compliant with 21 CFR Part 11 regulations. These enhancements reflect Integral Molecular’s commitment to maintaining a robust and compliant research environment.
Benjamin Doranz, CEO of Integral Molecular, highlighted the significance of the MPA technology: "The MPA is essential for testing the specificity of therapeutic antibodies, which ensures they engage with their target proteins effectively. While data generated from MPAs has been routinely included in regulatory submissions, achieving formal qualification as a DDT will significantly streamline the review process by regulatory bodies."
The current trajectory of the MPA is particularly notable as it is set to be one of the first technologies assessed under the FDA's ISTAND Program (Innovative Science and Technology Approaches for New Drugs). The submission of the Full Qualification Package marks the final stage in the qualification process. It showcases Integral Molecular's commitment to establishing its NAM-based antibody specificity testing method as a regulatory standard.
Integral Molecular has been recognized for over two decades as a leader in creating transformative technologies that facilitate therapeutic discoveries against challenging protein targets. Their innovative approaches have been instrumental in the drug discovery efforts of more than 600 biotech and pharmaceutical companies, helping to develop therapies for various health conditions, including cancer, diabetes, autoimmune disorders, and viral infections such as SARS-CoV-2, Ebola, Zika, and dengue viruses. As the MPA progresses towards FDA qualification, it signifies a significant advancement in the methodology of antibody specificity testing, paving the way for more effective therapeutic interventions in the future.
Topics Health）
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