c-LEcta, a leading international supplier of enzymes for the biopharmaceutical industry announces the launch of DENARASE® High Salt, an engineered version of its top-selling product DENARASE. DENARASE is a recombinantly produced Serratia marcescens endonuclease that is used for removal of DNA/RNA impurities during the production of biopharmaceuticals. DENARASE is well established in the biopharma industry and is used in various commercial and clinical stage vaccine and gene therapy manufacturing processes.
The newest addition to the DENARASE portfolio has been especially designed to retain activity at higher salt concentrations and a broad pH spectrum. These features provide customers with greater process flexibility and increased cost efficiency in viral vector manufacturing processes that benefit from elevated salt levels.
Revolutionary Engineering for High-Performance Results
DENARASE High Salt was developed using c-LEcta’s proprietary enzyme technology platform ENESYZ®. Compared to the wild-type enzyme, a combination of amino acid substitutions were introduced to provide its increased salt tolerance. Thanks to the great similarity with the wild-type enzyme, customers can use existing ELISA Kits for the detection of Serratia marcescens endonucleases to monitor residual DENARASE High Salt. In addition, customers also benefit from a well-established manufacturing process.
A Strategic Advantage for Various Industries
DENARASE High Salt is a perfect addition to the existing DENARASE portfolio. Customers can now rely on DENARASE products independent of the application. DENARASE High Salt enables optimal and cost-effective removal of nucleic acids in all biomanufacturing process steps that benefit from higher salt concentrations. Key applications include:
Viral Vectors for Cell & Gene Therapies
Viral Vaccines
Viscosity reduction in Lysates
Sample preparation in Electrophoresis and Chromatography
This strategic innovation aligns with c-LEcta’s products for efficient DNA/RNA removal, which currently consist of DENARASE in different qualities and packaging sizes and an ELISA Kit. The extended toolkit enables customers to streamline their workflows in a wide range of R&D and manufacturing processes and to consistently achieve the highest quality standards. DENARASE High Salt is now available in R&D-grade quality; a GMP-grade version is expected to be launched in the second quarter of 2025.