DENARASE®

For enzymatic DNA removal in bioprocessing!

  • Drug Master File for DENARASE approved by FDA

    c-LEcta has reached a major milestone with the successful submission of a Drug Master file at the US FDA for DENARASE®.

    This registration will reduce the regulatory work for DENARASE® customers who are looking for a US-market approval of a therapeutical product, such as vaccines and advanced therapy medicinal products. The Master File demonstrates the suitable quality of DENARASE® for use in pharmaceutical products.

    For more detailed information how to use the DMF File please request the US FDA DMF Support for DENARASE® GMP-grade.

About DENARASE

How it works

DENARASE® specifically hydrolyzes the phosphodiester bonds between nucleotides leaving smaller fragments of around 5 ­– 8 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.

Not quite ready to buy yet?

  • Get your free sample DENARASE!

    New customers from the pharmaceutical industry can request a free 25 kU sample for first lab trials. Please fill out the request form to get your free sample.

  • ELISA-Kit for analytical support

    Learn more about our ELISA Kit

    For the quantitative analysis of endonucleases from Serratia marcescens a DENARASE® ELISA detection kit is available.

    Learn more

Get in touch with our DENARASE expert team!

Vaishnavi Devarakonda
Vaishnavi Devarakonda DENARASE Sales +49-341 3552 140
Melissa Rangel
Melissa Rangel DENARASE Sales +49-341 3552 140
José Vázquez
José Vázquez Key-Account-Manager DENARASE +49-341 3552 140

Speak to a member of our expert team and learn more about our DENARASE products!

Qualified and used
by big pharma companies

  • „We have used DENARASE in our manufacturing production. It is good according to our test. We plan to use it in next valuable schedule.”

    US-Children Hospital, USA,
    Clinical Vector Core, Lead Scientist

  • „I tested the DENARASE yesterday and it was equally good as our standard in my setting. I will continue using it in variety of conditions that I normally use and I will most certainly be purchasing my future enzymes from you.”

    US University, USA,
    Scientist

  • „We are going to use DENARASE exclusively and no longer our usual nuclease. The product is excellent in performance and price.”

    US biopharmaceutical manufacturer, USA,
    Lab Manager Vector Production