DENARASE®- Precision Nuclease for Cleaner Bioprocessing
Products for use in research and development & GMP For process development and GMP manufacturing of biologicals such as viral vectors and vaccines. Removing all forms of DNA and RNA, DENARASE® enhables a simpler, more efficient downstream process. 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.
| Catalog No. | Size | Quality Grade | Availability | Price | Qty | Order |
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| 20804-100K | 100 kU | R&D | In Stock | $599.50 |
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| 20804-500K | 500 kU | R&D | In Stock | $1,831.50 |
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| 20804-1000K | 1000 kU | R&D | In Stock | $2,673.00 |
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| 20804-5000K | 5000 kU | R&D | In Stock | $8,948.50 |
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| 20804-1M | 1 MU | GMP | In Stock at Manufacturer | $3,156.00 |
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| 20804-5M | 5 MU | GMP | In Stock at Manufacturer | $10,573.00 |
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Choose Size, then Quality Grade.
Overview
What is denarase®- precision nuclease for cleaner bioprocessing?
About DENARASE®
How DENARASE® 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 production process uses a gram-positive Bacillus sp. production host, which minimizes the risks of endotoxins in the product. No antibiotics, Triton X-100, materials with TSE/BSE risk, or raw materials of animal origin are employed in the manufacture of the product.
DENARASE® is available in two quality grades
DENARASE® for Research and Development (R&D) use & DENARASE® for manufacturing under GMP.
- DENARASE® R&D-grade is produced in conformity with the ISO 9001 standard, with less strict requirements regarding documentation, storage, and distribution.
- DENARASE® GMP-grade is manufactured under EU GMP conditions.
- 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: 1,000 / 5,000 kU for R&D-grade DENARASE® and 1 / 5 MU for GMP-grade DENARASE®.
Details
Specifications
Applications
Applications & how to use
Viral Vector Production
Upstream manufacture of AAV, lentiviral and adenoviral vectors in producer lines such as HEK 293. Raw materials used at this stage must carry documentation suitable for regulatory submission.
Vaccine Production
Propagation of vaccine substrates in cell lines such as Vero and MDCK. Animal origin-free processing aids reduce adventitious-agent risk and simplify the regulatory dossier.
Host Cell DNA Removal
VLP Production
Biofilm Removal
Protein Purification
Separating a target protein from a complex mixture while keeping it folded and active, using chromatography, spin columns, selective binding or buffer exchange. Recovery and retained activity matter more than purity alone, so an activity assay should accompany the gel at each step.
Downstream Bioprocessing
Evidence
Validation & QC
Validation data for this product isn’t published yet.
Need specific QC or validation results — titer, purity, endotoxin, or assay data — for your application? Our scientific team can share what is available for this product and lot on request.
Request validation dataManufacturing
How it's made & quality control
Supplier quality control
Batch release specification
\nAppearance: clear, transparent solution. Activity above 250 U/µL by photometric assay. Purity ≥ 99% (standard DENARASE®) or ≥ 98% (High Salt) by SDS-PAGE with silver staining. Specific activity above 6 × 10⁵ U/mg. No protease activity detectable. Endotoxin below 0.25 EU/kU by LAL per Ph. Eur. 2.6.14 Method C. Microbial count per Ph. Eur. 2.6.12: aerobic bacteria and yeast or moulds each below 5 cfu per 200 µL.
Clearance validation
\nThe DENARASE® ELISA Kit is a monoclonal antibody-based sandwich ELISA for residual Serratia marcescens endonuclease in process samples, covering standard DENARASE®, DENARASE® High Salt and Benzonase®. Limit of detection 4 pg/mL, limit of quantification 12 pg/mL, working range approximately 32–1,000 pg/mL, assay time approximately 130 minutes. For High Salt, apply a correction factor of 1.46. Benzonase® is a registered trademark of Merck KGaA.
Documents available
\nProduct Information Sheets and Product Specifications for R&D and GMP grades; Validation Guide; guidance on qualifying DENARASE® in biopharmaceutical manufacturing; Change Guidance Document for grade transition; US FDA Drug Master File support documentation; ELISA Kit user instructions, kit contents and prevalidation report.
Supplier-level quality statement. For lot-specific results, request the Certificate of Analysis for your batch.
Resources
Documents & downloads
Questions
Frequently asked questions
What are the key benefits of using DENARASE®?
Reliable, economical DNA clearance across a broad salt spectrum and pH range.
High activity on all forms of DNA and RNA.
Produced under GMP conditions in accordance with EU GMP regulations.
R&D and GMP grades with equivalent performance.
Manufactured free of animal-derived materials, antibiotics and Triton X-100.
Endotoxin-free expression host.
Companion one-for-all Serratia marcescens ELISA Kit for clearance validation.
Is DENARASE® a cost-efficient alternative to Benzonase® for AAV and other bioprocess applications?
A peer-reviewed study on AAV production (Nascimento et al., Journal of Biotechnology, Vol. 408, 72–79, December 2025, doi: 10.1016/j.jbiotec.2025.09.002) used DENARASE® as a more economical solution compared with Benzonase®. Efficiency depends on buffer composition, dosing, scalability and downstream design, so results will vary between processes — small-scale feasibility testing is recommended before switching.
What is the delivery time for DENARASE® products?
R&D grade is held in US stock and ships in 2–3 business days. GMP grade is held at the manufacturer, typically 1–2 weeks.
What can DENARASE® be used for?
DENARASE® hydrolyses phosphodiester bonds between nucleotides, leaving fragments of roughly 3–5 base pairs. It is active on all nucleic acid forms — single- and double-stranded, linear, circular and supercoiled — and is widely used in research, process development, and production of viral vectors and vaccines.
What are the recommended usage conditions?
Peak performance at low to physiological salt: recommended for use below 150 mM NaCl. Release assay conditions are 0 mM NaCl and 1 mM MgCl2. Recommended starting concentration is 10–100 U/mL; optimise incubation time, enzyme concentration and temperature for your own process.
What are the main application fields?
Viral vector production (AAV, lentivirus, HEK293): added during or after cell lysis to reduce viscosity, degrade nucleic acids and simplify downstream purification.
Vaccine manufacturing (live attenuated, inactivated, VLP): reduces host cell DNA during harvest, improves process robustness and helps prevent aggregation.
Are there different quality grades?
Two grades, technically equivalent and released against the same specification parameters. R&D grade is produced under ISO 9001 with less strict documentation, storage and distribution requirements. GMP grade is manufactured under EU GMP with US FDA Drug Master File support and GDP-compliant distribution.
What should I consider when comparing DENARASE® and Benzonase® performance?
c-LEcta has published a comparative study using the DENARASE® activity release test to compare both enzymes directly — useful when establishing a dual-sourcing strategy. Data is available via the downloads section. Benzonase® is a registered trademark of Merck KGaA.
Does the DENARASE® ELISA Kit also detect Benzonase®?
Yes. The DENARASE® ELISA Kit quantifies DENARASE®, DENARASE® High Salt and Benzonase® in a single assay for residual Serratia marcescens endonuclease monitoring, with a limit of detection of 4 pg/mL and a limit of quantification of 12 pg/mL. Benzonase® is a registered trademark of Merck KGaA.
How can DENARASE® be removed from my process?
Anion exchange, cation exchange, hydrophobic interaction, hydroxyapatite or size exclusion chromatography, and filtration techniques. The appropriate media should be evaluated case by case.
How can enzyme activity be inhibited?
Approximately 600 mM NaCl is sufficient. Potassium phosphate at 200–300 mM can also quench activity depending on buffer composition, and EDTA above 5 mM inhibits the reaction by removing free magnesium ions.
Are DENARASE® products tested for endotoxins?
Yes. Every batch must meet the endotoxin specification of less than 0.25 EU/kU before release, tested by LAL assay according to Ph. Eur. 2.6.14 Method C. See the Validation Guide for full details.
Answered by our team
Questions from researchers
No researcher questions have been answered for this product yet. Ask our technical team and we'll get back to you — approved answers are published here.
Ask our technical team
Reviewed by a scientist — typically answered within one business day.
Deals
Promotions
Codes apply at checkoutReferences
Citations & references
A selection of peer-reviewed publications and reports referencing or featuring DENARASE®.
Viral Vectors for Gene Therapy and Vaccine Production
22 publicationsProduction of Virus-like Particles (VLP)
10 publicationsProduction of Bacteriophages
2 publicationsBiofilm Removal
2 publicationsProtein Purification
5 publicationsIn the literature
Research using this product
Every paper below cites this product's catalogue number in its methods. Each entry shows what was measured, the sample type where the paper states it, and the sentence the catalogue number appears in, and a link to the figure showing that data — so you can confirm the use case before citing.
Auto-discovered from Europe PMC by manufacturer number / product name / keyword plus supplier. A match may reference a related product; confirm relevance before citing.
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Customization & add-ons
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