Abstract: This research focused on the high throughout method for developing of antibody concentration detection based on the Bio-layer interferometry (BLI). The method gained the optimum efficiency with a 2 minutes binding on protein A sensor at a temperature of 30℃ and a shake speed of 400 r/min. The validation includes specificity, repeatability, accuracy and durability. The results showed that it fit a good linear relationship within an antibody concentration range of 0.781-400 μg/mL; relative deviations of repeatability including precision, intermediate precision and inter-day precision were below 2.5%. The accuracy ranged from 94.46% to 114.00%, the detection limit was 0.781 μg/mL and the limit of quantification was 1 μg/mL. The results certified the reliability of the method. The method can be used for detection of samples with a large scale benefitt from its high speed and throughout.

Key words: bio-film interferometry(BLI), monoclonal antibody, high throughput