Design and Validation of a Model of a Receptor Occupancy Assay for a New Immunotherapy in Human Whole Blood Specimens

Authors: Angela Pell, Carissa Moore, Lynette Brown and Jennifer J Stewart
Flow Contract Site Laboratory, 18323 Bothell Everett Highway, Suite 110, Bothell, WA 98012

Introduction: Antibody based immunotherapeutics are a growing field of treatment for a variety of disease indications. When conducting safety and efficacy studies, it is important to understand what cells and cell surface receptors your antibody drug is binding to, how long it binds, and the turnover rate of the receptor/drug combination in the patient. Flow cytometry-based receptor occupancy assays on whole blood are the fastest and easiest way to determine this. Developing and validating these assays takes time and knowledge of both immunology and flow cytometry.