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About DENARASE®

How it works
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.

 
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DENARASE® is available in two quality grades:

DENARASE® for Research and Development (R&D) use & 
DENARASE® for manufacturing under 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.

  • In order to avoid mix-ups, packaging units of the same size are indicated differently in the product name of the two quality standards: 1000/5000 kU for R&D-grade DENARASE® and 1/5 MU for GMP-grade DENARASE®.

Order & test DENARASE® now!

  • R&D-grade

    Products for use in research and development

    For process development of biologicals such as viral vectors and vaccines. The enzyme cleaves all forms of DNA and RNA and enables a simpler, more efficient downstream process.
     
    Purity: ≥ 99%​
    Activity: > 250 U/µl​
    Formulation:     buffered aqueous glycerol solution
    Storage Temperature:     -20°C
    Estimated Delivery time:     1-2 weeks (depending on region)
     
    • Produced in conformity with ISO 9001 standard
    • Manufacturing free of animal derived raw materials and antibiotics
    • Depending on your application 10 – 60 U/ml is needed ​
    • Net price excluding VAT and shipment costs
    DENARASE_GMP_R&D_1

    Choose your size for DENARASE® R&D-grade:

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  • GMP-grade

    GMP products for biopharmaceutical manufacturing

    For GMP manufacturing of biologicals such as viral vectors and vaccines. The enzyme reduces all forms of DNA and RNA and enables a simpler, more efficient downstream process.
     
    Purity: ≥ 99%​
    Activity: > 250 U/µl​
    Formulation:     buffered aqueous glycerol solution
    Storage Temperature:     -20°C
    Estimated Delivery time:     1-2 weeks (depending on region)
     
    • Produced under EU GMP conditions
    • Manufacturing free of animal derived raw materials and antibiotics
    • Dedicated regulatory support for US-market approvals of pharmaceutical products via own US FDA Drug Master File
    • Net price excluding VAT and shipment costs
    DENARASE_GMP_1

    Request price for DENARASE® GMP-grades:

    Back to the section
  • Free Sample

Products for use in research and development

For process development of biologicals such as viral vectors and vaccines. The enzyme cleaves all forms of DNA and RNA and enables a simpler, more efficient downstream process.
 
Purity: ≥ 99%​
Activity: > 250 U/µl​
Formulation: buffered aqueous glycerol solution
Storage Temperature: -20°C
Estimated Delivery time: 1-2 weeks (depending on region)
 
  • Produced in conformity with ISO 9001 standard
  • Manufacturing free of animal derived raw materials and antibiotics
  • Depending on your application 10 – 60 U/ml is needed ​
  • Net price excluding VAT and shipment costs
DENARASE_GMP_R&D_1

Choose your size for DENARASE® R&D-grade:

GMP products for biopharmaceutical manufacturing

For GMP manufacturing of biologicals such as viral vectors and vaccines. The enzyme reduces all forms of DNA and RNA and enables a simpler, more efficient downstream process.
 
Purity: ≥ 99%​
Activity: > 250 U/µl​
Formulation: buffered aqueous glycerol solution
Storage Temperature: -20°C
Estimated Delivery time: 1-2 weeks (depending on region)
 
  • Produced under EU GMP conditions
  • Manufacturing free of animal derived raw materials and antibiotics
  • Dedicated regulatory support for US-market approvals of pharmaceutical products via own US FDA Drug Master File
  • Net price excluding VAT and shipment costs
DENARASE_GMP_1

Request price for DENARASE® GMP-grades:

Not quite ready to buy yet?

DENARASE® expert team

Get your free sample DENARASE®!

New customers from the pharmaceutical industry can request a free 25 kU sample for first lab trials. 

c-LEcta-DENARASE-ELISA-Kit

Powerful kit for analytical support!

DENARASE® ELISA kit: For the quantitative analysis of endonucleases from Serratia marcescens.

Development of DENARASE®

2009-2012

Start of DENARASE® project: Strain selection, development of upstream and purification process

Project started: Application of en­do­nu­clea­ses for DNA removal during protein purification

c-LEcta‘s Bacillus strain, an endotoxin-free expression host, yielded highly active DENARASE product. Purity of ≥99 % was achieved after purification.

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2012

Manufacturing of DENARASE® under GMP conditions

Requirements of the biopharmaceutical industry for a GMP product were identified

Partnering with a contract manufacturing organization (CMO) to produce DENARASE® under EU GMP conditions

Manufacturing process free of animal derived raw materials and antibiotics was established

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2012

Product launch of DENARASE®

DENARASE® fulfills highest quality standards for biopharmaceutical manufacturing

Starting to build a global sales and distribution network for life science customers

Growth of internal quality, production, distribution and sales functions

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2017

First DENARASE®-related patents granted

Patents were successfully granted for the production technology of DENARASE® based on recombinant expression in Bacillus

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2020

Launch of DENARASE® ELISA Kit

Launch of own ELISA kit for the detection of S. marcescens endonucleases in process-derived samples

Fastest and most sensitive ELISA kit available on the market

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2020

COVID-Support

Focused support for customers developing and manufacturing COVID-19 vaccines at unprecedented speed
Concerted efforts of c-LEcta teams with COVID-19 vaccine customers succeeded in the delivery of large, unplanned quantities of DENARASE on short timelines
c-LEcta’s resilient manufacturing and distribution network kept COVID-19 related supply issues to general customers at an absolute minimum

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2021

Drug Master File for DENARASE® accepted by FDA

Dedicated regulatory support for US-market approvals of pharmaceutical products via own US FDA Drug Master File.

In addition, certified compliance with the EXCiPACT and ANSI NSF 363 Standard (meeting GMP for pharmaceutical excipients)

EXCIPACT-Collage

2022

Global application of DENARASE® and ELISA Kit in biopharma­ceutical manufacturing

DENARASE® and ELISA Kit are established highest-quality products, applied in the manufacturing of viral vectors for Gene therapies and vaccines:
> 150 customers in > 30 countries
DENARASE® is applied in 4 Commercial and 40+ Clinical Phase I-III viral vector manufacturing processes

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2023

New sizes of R&D-grade DENARASE® available

c-LEcta has just launched additional sizes of DENARASE® for research and development use.

Being widely applied in biopharmaceutical R&D and manufacturing, DENARASE sizes of 1 MU and 5 MU will now also be available as R&D-grade, in addition to GMP-grade.



R&D
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Get in touch with our DENARASE® expert team!

Vaishnavi Devarakonda

Vaishnavi Devarakonda
DENARASE® Sales

Need support? Contact me!
Melissa Rangel

Melissa Rangel
DENARASE® Sales

Need support? Contact me!

Cynthia Hofmann-Orsetti

Cynthia Hofmann-Orsetti
DENARASE® Sales

Need support? Contact me!