Immunoassays and other types of ligand-binding assays are widely used in the development of monoclonal antibody (mAb) therapeutics to measure antibody titers and support downstream purification processes by tracking impurities such as host cell proteins (HCPs) and leakage of protein A from affinity chromatography columns. While scaled down bioprocess development models and high-throughput testing generate large numbers of samples for analysis, immunoassays remain largely manual in many companies, resulting in high assay variability and low productivity. In contrast, automated immunoassays performed in nanoliter-scale microfluidic structures in the compact disk (CD) format of Gyrolab® systems deliver high quality data quickly and with a high pass rate to drive faster decision making. With over three logs of dynamic range, up to 960 data points can be generated in a working day. These miniaturized immunoassays are also adapted for bioprocess workflows to accelerate Quality-by-Design (QbD) strategy initiatives.
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