Integral Molecular proudly announces the achievement of IS0 9001 certification for the quality systems and processes used in its Membrane Proteome Array™ specificity testing services.
ISO 9001 certification validates Integral Molecular’s quality processes for its Membrane Proteome Array, reflecting the company’s commitment to quality.
PHILADELPHIA, March 27, 2024 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery and characterization, proudly announces the achievement of IS0 9001 certification for the quality systems and processes used in its Membrane Proteome Array™ (MPA) specificity testing services. This platform is a vital tool for biotechnology and pharmaceutical companies to assess the safety and off-target reactivity of therapeutic antibodies and other biologics.
Despite their reputation for ‘exquisite specificity’, antibodies and antibody-based therapies, such as CAR-T cells, frequently demonstrate unexpected off-target binding. The MPA utilizes its collection of over 6,000 native-conformation membrane proteins that encompass nearly the entire human membrane proteome to de-risk therapeutics and reveal unintended off-target liabilities early in drug development.
Learn more about the Membrane Proteome Array™
ISO 9001 is a globally recognized standard for quality management systems (QMS) that encompass process controls, comprehensive documentation, plans for corrective action, and continuous improvement.
“Integral Molecular has maintained a culture of commitment to delivering exceptional quality products and services for over 20 years. As the industry increasingly relies on MPA specificity profiling to support drug safety, we are delighted to receive ISO 9001 Certification to reinforce our commitment to quality for our customers.”
-Rachel Fong, Director of Sales and Alliances, Integral Molecular
With the ability to pinpoint the identity of unanticipated protein interactions that could pose safety consequences, the MPA was accepted by the FDA to participate in the agency’s ISTAND program to qualify new drug development tools for IND, NDA, or BLA applications. The MPA qualification plan was submitted to the FDA in 2023 and is currently under review.
About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing 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, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com
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SOURCE Integral Molecular
