Poster: Development of a Receptor Occupancy Assay for a Therapeutic Bi-Specific Antibody

Authors: Carissa R Moore PhD, Sarah Cocris BA, Dominic French MS, Lynette Brown MS, Jennifer J Stewart PhD; Translational Drug Development (TD2)

poster

Abstract: Therapeutic Bi-Specific Antibodies (BsAb) are increasingly being developed by biopharmaceutical companies for a variety of disease indications.  These drugs are designed to bind to two different antigens to cause a biological response. This response requires that enough of the drug is present in the body to bind to both targets of interest and thus must be measured. The normal method to measure target antigen binding of antibody-based drugs is called a receptor occupancy assay and is suggested by the FDA for this class of drug.  However, measuring receptor occupancy with two sites for the drug to bind to, is not straightforward. 

Download Now

CONTACT US

Get Started.

Have questions about how TD2 can assist with your regulatory needs? Reach out to our expert staff today to get started.