Development of a Novel Immunoassy for Detection of Anti-Drug Antibodies to a Gene Therapy Drug CR2-CR1 in Non-Human Primates using MSD bridging format

Abstract

Biopharmaceuticals are becoming a leading method of treatment for many diseases, but the trigger of unwanted immune responses that result from many of these manufactured therapeutic drugs prevent most from reaching the market. Immunogenicity is a driving factor for the importance of therapeutic protein drug development because of possible life-threatening complications. Fortunately, there is an FDA multi-tiered testing approach to measure immunogenicity response though assessment of anti-drug antibodies. One therapeutic protein, CR2-CR1 drug, is the focus of this method development for the design of an immunoassay that can accurately detect ADA to CR2-CR1 in preclinical studies in non-human primates. The assay shows specificity for ADA and a drug tolerance assessment determined the relative concentration of circulating drug that can circulate in non-human primate serum without negatively affecting ADA detection. The development of this assay provides the groundwork that will lead to the next phase of clinical drug testing in humans.