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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.
View a case study from Medimmune, "One mouse one PK: The magic of capillary microsampling and the Gyrolab assay platform", demonstrating the use of capillary microsampling to reduce the number of mice in each PK group from 20 to 4 and increase throughput in a preclinical PK study.
Assay stability throughout your biotherapeutics clinical study for PK, ADA, and affinity measurement is achievable with Gyrolab® microfluidic, automated immunoassay platform. The nanoliter-scale flow-through affinity column design allows rapid analyte binding and results in about one hour. Assay development can be accomplished in as little as one day, speeding up method validation beyond your expectations based on plate-based methods. As a result, Gyrolab immunoassays provide high throughput bioanalysis for 24/7 data collection with stable assay results throughout the study.
The flow-through column design of the Gyrolab Bioaffy CD minimizes potential matrix interference, reducing the need for dilutions of clinical serum samples or other biological matrices. Assay performance is consistent between instruments, facilitating the transfer of Gyrolab immunoassays to outside CRO partners, and Gyrolab software is designed for 21 CFR Part 11 compliance, with data accepted for regulatory submissions.
In this summary of three case studies, PK and biomarker analysis are demonstrated from preclinical through late-phase clinical studies: "Maximizing productivity in biopharmaceutical research and clinical development."