FDA receives letter of interest (LOI) to test specificity of molecular membrane antibodies as part of ISTAND drug development tool pilot program
PHILADELPHIA , September 7, 2022 /PRNewswire/ — Integral Molecular, the leader in membrane protein antibody discovery, has joined the US Food and Drug Administration (FDA) ISTAND trial program ). This program supports me
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Despite their reputation for “excellent specificity,” antibody-based therapies such as antibodies and CAR-T cells often exhibit unexpected target binding. Integrated Molecular Membrane Proteome Array (MPA) for antibody specificity and safety analysis in vitro designed to address ICH-FDA issues
MPA is one of the largest collections of membrane proteins for the specific analysis of antibody-based therapies. More than 6,000 naturally occurring membrane proteins make up nearly the entire human membrane protein system. The technology is believed to be compatible with a number of biological therapies, including monoclonal antibodies, dual-specific therapies, and CAR-T.
“We are excited to be working with the FDA’s ISTAND program,” said Benjamin Dorantz, CEO of Integral Molecular. “We are showing FDA interest in developing it in vitro
The FDA released a statement regarding this LOI estimate for the ISTAND trial program: https://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements#statements
About the integral molecule
Integral Molecular (integralmolecular.com) is an industry leader in the development and application of innovative technologies to advance therapeutic discoveries against complex protein targets. With 20 years of experience in membrane proteins and antibodies, Integral Molecular Technology has been integrated into the drug discovery systems of more than 400 biotech and pharmaceutical companies to help uncover targets against pathogens. threats from viruses such as cancer, diabetes, autoimmune diseases and the new SARS. to treat. CoV-2, Ebola virus, Zika virus, and dengue virus.