A rapid lateral flow immunoassay for identity testing of biotherapeutics.

Identity testing of biopharmaceutical products is conducted at multiple steps in the manufacturing process, for drug product lot release, and often for product importation. Because of the chemical and structural similarities of antibody-based products, they present a unique challenge for the development of a QC friendly identity assay where specificity is the critical attribute. Here we report on the development of a novel, rapid and highly specific assay designed to simplify identity testing of antibody-based biopharmaceutical products.