Rapid results from early preclinical PK, ADA, and affinity screening can move biotherapeutic candidates forward into development faster. With run times of about an hour for Gyrolab® immunoassays, delays in bioanalysis data supporting preclinical toxicology and safety studies can be avoided and deadlines met. Assay development using Gyrolab immunoassays can be completed in days, not weeks, keeping bioanalysis on track for preclinical toxicology and safety studies for biologics in development. Gyrolab microfluidic, flow-through affinity column assay format of the Gyrolab Bioaffy CD minimizes matrix interference, reducing the need for dilutions and sample re-runs, saving analyst time.
The low sample volume requirement of <10 µL has opened the door to utilization of serial sampling from one mouse to produce a complete PK profile. Microsampling approaches are in line with the principles of the 3Rs (Replacement, Reduction and Refinement) for animal research, reducing the number of animals needed for preclinical PK analysis of biotherapeutics.