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. A lateral flow immunoassay platform (LFIA) was optimized and used to develop seven identity-specific tests against therapeutic monoclonal antibodies. The specificity of each assay was verified against 10-40 antibody products. An average linear range of antibody detection from 50 to 10,000 ng/ml was observed, allowing minimal sample dilution to be performed. The optimized LFIA platform consistently produced a strong visual signal and showed no false positive results. Three of the seven LFIA-based identity assays have been successfully validated for product release, in accordance with ICH validation guidelines. Additional tests will be validated as products reach the commercial phase. We demonstrate that a lateral flow-based identity assay is an ideal analytical tool for identity testing of antibody therapeutics. The assay platform can easily be adapted for new antibody products and it can be quickly transferred and validated for product testing.