Integral Molecular Secures $2.7 Million Grant for Membrane Array
Integral Molecular, recognized as a frontrunner in antibody discovery, has secured a significant $2.7 million grant from the NIH Commercialization Readiness Pilot (CRP) Program. This vital funding aims to propel the FDA-qualification of the Membrane Proteome Array™ (MPA), a cutting-edge technology that plays a crucial role in providing essential safety data necessary for Investigational New Drug (IND) applications for biologic drugs.
Understanding the Membrane Proteome Array™ Technology
The MPA is an innovative cell-based protein array specifically designed for testing the specificity of antibody-based therapeutics. Unlike traditional methods, this platform utilizes native protein conformations to ensure that the screening is as accurate as possible. Integral Molecular’s data highlights a critical concern in the industry: nearly one-third of antibody drugs exhibit non-specific binding. This issue poses a serious risk, contributing to drug failures that affect patient outcomes.
The Shift Towards Enhanced Safety Protocols
Research conducted by Integral Molecular indicates that off-target binding is a significant factor behind drug failure. Notably, even existing drugs currently on the market demonstrate non-specific binding when assessed with outdated technologies like tissue cross-reactivity (TCR). The NIH funding will enable Integral Molecular to establish the MPA as a more reliable alternative to TCR, thereby setting a new standard for safety evaluations.
Industry Impact and Future Directions
The Membrane Proteome Array™ represents a leap forward in drug safety technology. As the company continuously strives for excellence, MPA processes are ISO 9001 certified, and the technology is currently under FDA review for qualification as a Drug Development Tool (DDT). Achieving DDT status would allow the MPA to be utilized in IND, NDA, or BLA applications, streamlining the drug development process and mitigating risks associated with non-specific binding.
Support from Key Industry Stakeholders
Integral Molecular’s CEO, Benjamin Doranz, expressed gratitude towards the NIH for their unwavering dedication to advancing drug safety tools. He noted that the NIH's support, ranging from initial grants to significant CRP awards, has been key in establishing the Membrane Proteome Array as the standard for in vitro specificity testing of biologics.
About Integral Molecular
Integral Molecular is an industry leader committed to developing transformative technologies that enhance the discovery of therapeutics targeting challenging protein structures. With over two decades of focused experience in membrane proteins, viruses, and antibodies, Integral Molecular’s innovations are integrated into the drug discovery processes of more than 600 biotech and pharmaceutical firms. Their advancements contribute to the development of therapies for critical health challenges, including cancer, diabetes, autoimmune diseases, and viral threats such as SARS-CoV-2.
Frequently Asked Questions
What is the Membrane Proteome Array?
The Membrane Proteome Array is a state-of-the-art technology developed by Integral Molecular for evaluating the specificity of antibody-based therapeutics.
What is the significance of the $2.7 million grant?
This funding will facilitate the FDA qualification of the Membrane Proteome Array, enhancing its role as a drug development tool in the industry.
How does the MPA improve drug safety assessments?
The MPA provides a more accurate method of examining non-specific binding, thus reducing the risk of drug failure due to off-target interactions.
What certifications does Integral Molecular hold?
Integral Molecular’s MPA processes are ISO 9001 certified, ensuring a commitment to quality and industry standards.
How does Integral Molecular contribute to the biotech industry?
Integral Molecular's innovations are utilized by numerous biotech and pharmaceutical companies, aiding in the discovery of novel therapies for various diseases.
