EndonucleaseGTP® ELISA Kit

The Cygnus Technologies EndonucleaseGTP ELISA Kit is a sensitive and specific assay for the detection and quantification of residual endonuclease impurity in recombinant viral vector and vaccine preparations.

Expression of recombinant viral vectors and vaccines in mammalian cell culture is a cost-effective method for producing commercial quantities of gene therapy and vaccine biologics. The processes used to manufacture and purify these products, however, often use an endonuclease to remove endogenous host cell DNA and RNA, as well as unincorporated plasmid DNA from viral vector production. During purification, the endonuclease contamination must be reduced to the lowest levels practical.

The EndonucleaseGTP ELISA Kit is based on an antibody generated and affinity-purified against a genetically engineered endonuclease from Serratia marcescens. With a detection limit of ~0.06 ng/mL, it is a sensitive and specific method for residual endonuclease detection in purification process development, process control, routine quality control and product release testing.