Applications

Biotherapeutics continues to be a rapidly expanding sector of the biologics market in the race to produce effective and specific therapies for oncology, neuroscience, inflammation, metabolic and eye health disorders. Immunoassays provide information on ligand binding and protein quantitation of key factors in the analytical support of biotherapeutics from discovery to NDA/BLA submission in research and production.

Gyrolab^® systems are open platforms used for rapid development and processing of miniaturized immunoassays in quantitating proteins to advance biotherapeutic programs. Based on a flow-through affinity column format, Gyrolab technology automates assay workflows with minimal matrix interference at nanoliter volumes within a CD consumable under the control of Gyrolab instruments and Gyrolab Control software. Gyrolab systems produce high quality data in under an hour, enabling data driven decisions for critical timelines to support all stages of biotherapeutic development.

Biotherapeutic development is currently challenged by increasing costs, data quality, slow turnaround time and delays due to assay development and validation. Bioanalytical assays for biotherapetics require precise protein quantitation from complex matrices (e.g. serum or cell culture). Gyrolab systems support a wide range of applications requiring performance, productivity, throughput with time constraints for critical workflows throughout the entire drug development process.

Application Areas:

Pharmacokinetics/Toxicokinetics
“Better Science – fewer animals” Nanoliter-scale assays reduce animal usage in preclinical studies 

Pharmacodynamics & Biomarker Monitoring
Extract maximum biomarker/PD information from limited sample volumes

Immunogenicity
Automated sample pretreatment and immunoassay workflow at nanoliter-scale reduces hands-on time

Affinity
Design and evaluate in solution affinity runs using non-modified substances

Product Titer Quantitation
Broad dynamic range ensures high-sensitivity quantification throughout the development process

Impurities for downstream purification
Rapid quantification of contaminants enables data-driven decisions to be made throughout the biotherapeutics workflow