EndonucleaseGTP® Assay Reagent Set for Gyrolab® is designed for determining the presence of endonuclease impurities in recombinant vaccine and viral vector products. This Reagent Set should be used in conjunction with a Gyrolab® Bioaffy™ 1000 HC Assay Toolbox available from Gyros Protein Technologies.This simple-to-use and high-throughput assay is a method to aid in optimal purification process development, process control, routine quality control, and product release testing. It is derived from the same antibodies and antigen used in the Cygnus EndonucleaseGTP® ELISA kit, Cat# F960. The reagents are intended to monitor the optimal removal of endonuclease impurities that could contaminate the product during the purification process. The antibodies have been generated against affinity purified endonuclease. This highly sensitive Reagent Set, developed with these antibodies, is accurate, sensitive, and precise for detection of genetically engineered endonuclease from Serratia marcescens such as Benzonase® Nuclease and DENARASE® in samples throughout the purification process. The combination of the Reagent Set and Bioaffy 1000 HC Assay Toolbox is optimized for use in Gyrolab automated immunoassay systems enabling generation of 96 data points in 75 minutes without manual intervention. The results are evaluated using Gyrolab Evaluator software.
