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.
![DENARASE_GMP_1](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE_GMP_1.png?width=2000&name=DENARASE_GMP_1.png)
![DENARASE_R&D_1-1](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE_R%26D_1-1.png?width=2000&name=DENARASE_R%26D_1-1.png)
DENARASE® is available in two quality grades:
DENARASE® for Research and Development (R&D) use &
DENARASE® for manufacturing under GMP.
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DENARASE® GMP-grade is manufactured under EU GMP conditions
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DENARASE® R&D-grade is produced in conformity with the ISO 9001 standard, with less strict requirements regarding documentation, storage and distribution
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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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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
Choose your size for DENARASE® R&D-grade:
- 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
- Free Sample
Products for use in research and development
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](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE_GMP_R%26D_1.png?width=2000&name=DENARASE_GMP_R%26D_1.png)
GMP products for biopharmaceutical manufacturing
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](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE_GMP_1.png?width=2000&name=DENARASE_GMP_1.png)
Not quite ready to buy yet?
![DENARASE® expert team](https://denarase.c-lecta.com/hs-fs/hubfs/Unbenannt-1-1.jpg?width=1200&height=800&name=Unbenannt-1-1.jpg)
DENARASE® - Your complete toolkit for DNA removal
Pick the most efficient DENARASE® version for your application.
![c-LEcta-DENARASE-ELISA-Kit](https://denarase.c-lecta.com/hs-fs/hubfs/c-LEcta-DENARASE-ELISA-Kit.jpg?width=1200&height=800&name=c-LEcta-DENARASE-ELISA-Kit.jpg)
The One-for-all Serratia marcescens ELISA Kit!
For the quantification of residual Serratia marcescens endonucleases including DENARASE® High Salt.
Development of DENARASE®
2024
Launch of DENARASE® High Salt
c-LEcta launched DENARASE® High Salt, an engineered version of its top-selling product DENARASE®.
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.
![highsalt_Gruppe](https://denarase.c-lecta.com/hs-fs/hubfs/highsalt_Gruppe.jpg?width=2000&height=2000&name=highsalt_Gruppe.jpg)
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](https://denarase.c-lecta.com/hs-fs/hubfs/R%26D.jpg?width=1000&height=1000&name=R%26D.jpg)
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
![AdobeStock_335262300_Preview-1](https://denarase.c-lecta.com/hs-fs/hubfs/AdobeStock_335262300_Preview-1.jpg?width=1000&height=1000&name=AdobeStock_335262300_Preview-1.jpg)
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](https://denarase.c-lecta.com/hs-fs/hubfs/EXCIPACT-Collage.jpg?width=1000&height=1000&name=EXCIPACT-Collage.jpg)
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
![c-LEcta-covid-vaccine-1](https://denarase.c-lecta.com/hs-fs/hubfs/c-LEcta-covid-vaccine-1.jpg?width=1000&height=1000&name=c-LEcta-covid-vaccine-1.jpg)
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
![ELISA-Kit_1000x1000](https://denarase.c-lecta.com/hs-fs/hubfs/ELISA-Kit_1000x1000.jpg?width=1000&height=1000&name=ELISA-Kit_1000x1000.jpg)
2017
First DENARASE®-related patents granted
Patents were successfully granted for the production technology of DENARASE® based on recombinant expression in Bacillus
![DENARASE-Patent-USA](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE-Patent-USA.jpg?width=1000&height=1000&name=DENARASE-Patent-USA.jpg)
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
![DENARASE_1000x1000](https://denarase.c-lecta.com/hs-fs/hubfs/DENARASE_1000x1000.jpg?width=1000&height=1000&name=DENARASE_1000x1000.jpg)
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
![Production_1000x1000](https://denarase.c-lecta.com/hs-fs/hubfs/Production_1000x1000.jpg?width=1000&height=1000&name=Production_1000x1000.jpg)
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.
![Fermenter_1000x1000](https://denarase.c-lecta.com/hs-fs/hubfs/Fermenter_1000x1000.jpg?width=1000&height=1000&name=Fermenter_1000x1000.jpg)
Get in touch with our DENARASE® expert team!
![Vaishnavi Devarakonda](https://denarase.c-lecta.com/hubfs/Vaishnavi%20Devarakonda.jpg)
Vaishnavi Devarakonda
DENARASE® Sales
![Melissa Rangel](https://denarase.c-lecta.com/hubfs/Melissa%20Rangel.jpg)
Melissa Rangel
DENARASE® Sales
Need support? Contact me!
![Cynthia Hofmann-Orsetti](https://denarase.c-lecta.com/hubfs/Cynthia%20Hofmann-Orsetti.jpg)
Cynthia Hofmann-Orsetti
DENARASE® Sales
Need support? Contact me!