Breaking Barriers in Titer and Impurities Analytics with an Automated Microfluidic Immunoassay Platform
Titer and process-related impurities levels are critical quality attributes (CQA) in biotherapeutic manufacturing of therapeutic drugs, viral vectors and vaccines. Executing accurate and precise bioassays of different types for large sample sets in downstream analytics can cause workflow bottlenecks. Gyrolab® systems perform automated immunoassays within nanoliter-scale microfluidic structures in a Compact Disk (CD) format, increasing speed while reducing sample and reagent consumption as compared to plate-based ELISA. We present case studies from antibody and viral vector bioproduction runs, showing how titer and multiple types of impurities are being assessed in a walk-away format, reducing hands-on time and increasing productivity in bioprocess analytics.