Cygnus Technologies has introduced a new enzyme-linked immunosorbent assay (ELISA) test for use with recombinant vaccines and viral vectors in gene therapy to detect endonuclease impurities.
The company said that its EndonucleaseGTP ELISA kit has reagents for 96 analyses in microplate format and may be used at a range of points in the workflow process. Endonucleases are enzymes that cut DNA and RNA molecules.
"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," Cygnus said in a statement.
The kit has a detection limit of approximately 0.06 ng/mL, which the company said is very sensitive for the detection and quantitation of endonuclease impurities.
Cygnus, which is a division of Maravai LifeSciences, also sees the product as helping it branch out of assays for biotherapeutics and into vaccines and gene therapy biologics.