Biopharmaceutical therapies may elicit immune responses generating anti-drug antibodies (ADAs) that can have potentially serious adverse effects, including reduced efficacy and safety.
This has led to the development of a range of analytical methods to measure ADAs that have high sensitivity and are tolerant to high drug levels in the sample to meet regulatory requirements. The need for maximizing scientific productivity is driving a search for assay platforms that support low sample and reagent consumption, and that provide automation to increase reproducibility and throughput.
This White Paper presents case studies describing how Gyrolab platform meets the productivity and sensitivity demands of ADA analysis in biopharmaceutical preclinical and clinical studies. Automated acid pre-incubation with a specialized mixing CD and cut point analysis in ADA software can rapidly deliver reproducible ADA data with low consumption of samples and reagents.