Accelerating Bioprocess Workflows with Microfluidic Immunoassay-based Impurity Analysis

Contributing Authors: Chris Fox, Ann-Charlott Steffen and Hannah Litwin While scaled-down models and high-throughput testing methods in bioprocess development generate large numbers of samples for analysis, immunoassays for host cell proteins (HCPs) often remain manual in many companies. This manual approach often results in high assay variability and low productivity. However, the use of the automated Gyrolab® immunoassay platform, coupled with ready-to-use kits tailored for impurity detection, is improving analytical productivity at many biopharmaceutical companies. Here, we present data illustrating how the broad dynamic range and low matrix interference provided by Gyrolab technology improves the time required for analytical testing of HCPs impurities, including PLBL2, in Chinese hamster ovary (CHO) cell-derived monoclonal antibody samples by enabling the elimination of dilution steps. The automated platform provides additional data robustness and assay reproducibility between runs and requires >4 times less manual labor compared to traditional immunoassay methods such as ELISA.