#USA #Philadelphia #Drug Development #Integral Molecular #Membrane Proteome Array

Integral Molecular's Breakthrough in FDA Qualification

Integral Molecular, a prominent name in antibody discovery technologies, has achieved a significant milestone as the FDA has accepted their Membrane Proteome Array™ (MPA) Qualification Plan. This acceptance allows their innovative technology to advance as a Drug Development Tool (DDT) to precisely evaluate antibody binding specificity, a critical factor in drug safety.

Importance of Antibody Specificity

Antibody drugs have become indispensable in modern medical therapeutics. However, a pressing issue is non-specific binding, which can lead to serious adverse effects, including complications or even mortality. Notably, recent studies indicate that as much as one-third of antibody drugs demonstrate non-specific interactions with unintended targets. This highlights the necessity for early specificity testing during drug development phases, which is precisely what Integral Molecular’s MPA aims to address.

Integral Molecular's MPA stands out by assessing binding interactions across approximately 6,000 structurally complete membrane proteins, and it uniquely screens these proteins in their native forms. This has enabled the MPA to assist in screening over 2,000 preclinical antibody therapeutics worldwide. Additionally, the data obtained from the MPA has met acceptance criteria from various global regulatory bodies, including the FDA, EMA, and NMPA.

A Commitment to Safety and Quality

Benjamin Doranz, CEO of Integral Molecular, expressed pride in this achievement, emphasizing the company's continuous efforts to establish a new benchmark in testing the specificity of antibody drugs. The qualification of the MPA aligns with the FDA’s ISTAND Pilot Program, which promotes innovative scientific approaches toward new drug development.

The pathway to DDT qualification could further enhance the reliability of the MPA, allowing developers to integrate this technology into their regulatory submissions with increased assurance. Integral Molecular has been invited to provide a Full Qualification Plan (FQP) for the MPA, which is a crucial step towards securing DDT status.

An Innovative Future

Integral Molecular has long been at the forefront of creating transformative technologies that simplify the discovery of therapeutics aimed at challenging protein targets. With over 20 years of focused experience on membrane proteins, viruses, and antibodies, they have equipped more than 600 biotech and pharmaceutical entities with the necessary tools to develop therapies for diseases ranging from cancer and diabetes to viral threats, including SARS-CoV-2 and Ebola.

The company’s innovative advances, illustrated through rigorous statistical analyses and enhanced quality systems, have not only aided in securing this important FDA recognition but have also supported their processes' ISO 9001 certification.

As Integral Molecular progresses towards full qualification of their Membrane Proteome Array, the industry anticipates a stronger framework for drug safety and efficacy evaluations that could pave the way for more successful therapeutic developments in the future.

About Integral Molecular

Integral Molecular is a leader in biotechnological innovation focused on the discovery and development of antibody therapies. They have dedicated their efforts to refining the methodologies used for studying membrane proteins and their interactions, striving to ensure that therapies developed are both safe and effective for patients globally. To learn more, visit Integral Molecular.