The Cygnus Technologies EndonucleaseGTP® ELISA Kit is a sensitive and specific assay to detect and quantify residual endonuclease impurity in recombinant viral vector and vaccine preparations. The expression of vaccines and recombinant viral vectors in mammalian cell culture is a cost-effective method for the production of commercial quantities of vaccines and gene therapy. The manufacturing and purification process of these products leaves the possibility of contamination by the enzyme endonuclease which is often used to remove endogenous DNA and RNA from the host cell, as well as unincorporated plasmid DNA from viral vector production. It is desirable to reduce endonuclease contamination to the lowest practical levels.
The Cygnus EndonucleaseGTP® ELISA Kit is based on antibodies generated and affinity-purified against a genetically modified endonuclease from Serratia marcescens. With a detection limit of ~60 pg/mL, it is a sensitive and specific method to aid in purification process development, process control, routine quality control, and product release testing. The kit utilizes a simple simultaneous protocol where endonuclease-containing samples are simultaneously reacted with an HRP-labeled anti-endonuclease detection antibody on microtiter strips coated with an affinity-purified capture anti-endonuclease antibody.
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Assay format: 96-well plate
Time to result: ~1 hr. 50 minutes
LLOQ: ~0.31 ng/mL
Recommended thinner: I600
The EndonucleaseGTP® ELISA Kit contains all components to test for the presence of endonuclease impurities in 96 samples, including a set of calibrated endonuclease standards. It is suitable for the detection of genetically modified endonucleases such as Benzonase Nuclease and DENARASE. Use Sample Diluent, Item # I600, with these kits; available separately.