Where Programs Fail: Bridging Assay Development and Manufacturing for Lateral Flow

Your lateral flow assay performs at the bench. Will that performance hold on the manufacturing line? Manufacturing introduces conditions the assay may not have faced at the bench. Reagent delivery must remain consistent throughout longer runs, while materials move under tension on production equipment. Changes in dispensing and drying can expose signal variation, nonspecific binding, material failures, or yield loss. For immunoassay developers, finding those problems after the assay design is locked can send the program back into development. The better time to address them is during development, while the chemistry, materials, and process can still be evaluated together. In this episode of Expert Insights, DCN Dx Chief Operating Officer Pat Vaughan, Ph.D., who leads assay development, engineering, and manufacturing operations, joins host Trevor Brown, M.Sc., Chief Revenue Officer, to explain what changes between the bench and the manufacturing line. They discuss what immunoassay developers should evaluate before the design is locked and how assay scientists and manufacturing engineers can work together from the start.