DARPA Antibody Technology Program Standardized Test Bed for Antibody Characterization: Characterization of an MS2 sdAb Produced by U.S. Naval Research Laboratory

Abstract : The selection of antibodies for inclusion in a final assay format has primarily relied on an antibody's performance in an enzyme-linked immunosorbent assay, with little regard for quantification of the full spectrum of variables that affect antibody-antigen interactions. The Joint Product Management Office for Biosurveillance (JPMO BSV), Critical Reagents Program instituted a quality program for the standardization of test methods to support more-comprehensive characterization and comparison of the physical and functional properties of antibody reagents within its repository. The development and standardization of antibody testing provides JPMO BSV with an invaluable platform for providing consistent, high-quality assays and reagents for current biodetection platforms and for developing and validating future systems. This platform will be used to characterize and evaluate the MS2 recombinant antibody produced and supplied by the Defense Advanced Research Projects Agency (DARPA; Arlington, VA)-funded U.S. Naval Research Laboratory (Bethesda, MD) for affinity and stability enhancements. The study provides standardized parametric data on antibody properties and performance and contributes to the development of a decisional analysis tool used to expand the confidence level for selection of antibody-based reagents that will optimize field operational and performance metrics for future detection and diagnostic platforms.