Cygnus Technologies, the leading assay and services provider for the detection and characterization of impurities in biopharmaceuticals, introduces the EndonucleaseGTP™ ELISA Kit for the detection and quantitation of residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy. Endonucleases such as Benzonase* and Denarase* are often used to cleave host cell DNA and RNA during the production of these biologics and must subsequently be removed. The new Cygnus ELISA kit, with a detection limit of ~ 0.06 ng/ml, is three times more sensitive than the only other commercially available assay for detection and quantitation of these endonuclease impurities.

“The development and production of safe gene therapy and vaccine biologics requires unwavering attention to detection and removal of impurities,” commented Ken Hoffman, founder and president of Cygnus. “We’ve long been the pioneers and leaders in impurity analysis in biotherapeutics. Now we are extending that expertise to vaccines and gene therapy biologics.”

The EndonucleaseGTP ELISA Kit contains all the necessary ready-to-use reagents for 96 analyses in microplate format, including a set of calibrated endonuclease standards. The assay is easy to use and can be easily integrated into desired workflow points, from process development to QC to lot release testing.