What is DENARASE®?   >>View DENARASE® Products

The GMP endonuclease for viral vector manufacturing

In the manufacturing of viral vectors for gene/cell therapies and vaccines, removal of residual DNA and RNA from host cells and plasmids is critical to meet regulatory requirements and streamline vector purification. For this purpose, endonucleases are commonly added to enzymatically cleave polynucleotide chains to smaller fragments of around 3-5 base pairs. DENARASE® is a commercial name registered by our German partner, c-LEcta, for recombinantly produced endouclease from Serratia marcescens and is widely applied in the industry for the degradation of undesired DNA and RNA.

Working Principle

DENARASE® specifically hydrolyzes the phosphodiester bonds between nucleotides leaving smaller fragments of around 3-5 base pairs. The enzyme is active on all forms of nucleic acids including single-stranded, double-stranded, linear, circular or supercoiled. Best results are obtained when the enzyme is added before the release of DNA.

Production of DENARASE®

DENARASE® has been developed for use in commercial manufacturing processes of biologicals and complies with EU GMP regulations. The patented production process uses a gram-positive Bacillus sp. production host, which minimizes the risks of endotoxins in the product. No antibiotics, materials with TSE/BSE risk or raw materials of animal origin are employed in the manufacture of the product.


DENARASE® Technical Parameters
 

• One-Stop Complete Toolkit: DENARASE® is not just one prouduct; moreover, it represents a complete toolkit for enzymatic DNA removal in bioprocessing. The DENARASE® endonuclease is available in both R&D and GMP-grade, allowing for a seamless transition from early R&D stage towards biopharmaceutical manufacturing under GMP. Both quality grades are equal and the parameters on the specification are the same. Our partner, c-LEcta, has also developed DENARASE® High Salt, which was engineered for better salt and pH tolerance and can be used at 0-500 mM salt. The toolkit also includes DENARASE® ELISA Kit for the quantification of residual Serratia marcescens endonucleases.  >> Learn More about DENARASE ELISA Kit

• Cost-Effectiveness: DENARASE® offers a more financially viable alternative without compromising quality, making them attractive options for future projects. Click here to visit our website for pricing and order details.

• Molecular Efficacy: Engineered by c-LEcta for high activity (> 250 U/µl​), DENARASE® is exceptional for degrading host-cell DNA during AAV production, cleaving all forms of DNA and RNA to enable a simpler, more efficient downstream process.

• Robust Stability Even Under High Salt:  DENARASE® High Salt is an engineered version of DENARASE® that has been expecially 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.

• Regulatory Compliance: DENARASE® is available in two quality grades: R&D and GMP. DENARASE® GMP-grade is manufactured under EU GMP conditions. DENARASE® R&D-grade is produced in conformity with the ISO 9001 standard, with less strict requirements regarding documentation, storage and distribution. From a technical performance perspective, both quality grades are equal and the parameters on the specification are the same. This allows for a seamless transition from early R&D stage towards biopharmaceutical manufacturing under GMP.
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