Quantitation Kit for Human IgG
For use in quantitation of human IgG in rat serum on Gyrolab™ xP Workstations.
Vital to the drug development workflow is an understanding of pharmacokinetic (PK) properties of a biotherapeutic. A better understanding of PK properties will allow optimized design of treatment regimens to maximize clinical benefit of a therapeutic. In addition, the risk of side effects of the treatments can be reduced and efficiency of the treatment improved by finding the ideal dosage and schedule of treatments to maintain the desired concentration of therapeutic in the blood. Using Gyrolab technology, analytes can be measured in samples on the nanoliter scale, making it possible to obtain vastly more data from a single animal than with other, higher-volume platforms.
The goal of this assay is to provide analytical measurements for clients that need to evaluate the pharmacokinetics of their antibody-based biotherapeutics in a low-volume sample on the Gyrolab instrument. This kit has been developed under Fit-for-Purpose standards and the core principles of the 21st Century Bioanalytical Lab Initiative. Kit performance criteria include precision, accuracy, dilutional linearity, and specificity determinations. To facilitate lab to lab harmonization, the standards and controls are prediluted in matrix in automation compliant single use vials. The QC’s consist of a Low, a Medium, a High, and a Dilutional QC. The kit also provides an optimized method stored on a USB hard drive which can be imported directly into the Gyrolab software.
- Ready to Use Assay Components — enhance inter-lab harmonization of results
- Pre-Diluted Reagents
- Pre-Diluted Standards
- Four QC’s — Ready to Use LQC, MQC, HQC, and a Dilutional QC
- Automation Compliant Reagents (packaged in SBS standardized vials)
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