| Field | Specification |
|---|---|
| Concentration | |
| Endotoxin Level | |
| Expression System | |
| Form | Liquid solution |
| Formulation | |
| Product Type | |
| Protein Length | |
| Purity | |
| Shipping | |
| Source | Recombinant, expressed in Bacillus sp. |
| Species | |
| Storage | |
| UniProt # |
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®.
- Product Information Sheet (PDF)
- Product Specification DENARASE GMP-grade (PDF)
- Product Specification DENARASE R&D-grade (PDF)
- Validation Guide (REQUEST-VALIDATION-GUIDE)
- Guidance on Change to DENARASE in Biopharmaceutical Manufacturing Processes (REQUEST-GUIDANCE-ON-CHANGE-TO-DENARASE)
- US FDA DMF Support Document (REQUEST-DMF-SUPPORT)
- Guidance on how to qualify DENARASE in Biopharmaceutical Manufacturing Processes (REQUEST-GUIDANCE-ON-HOW-TO-QUALIFY-DENARASE)
DENARASE® — Enzyme Characteristics
DENARASE® is a very robust enzyme that enables DNA clearance under varying conditions. Its activity depends on various factors, such as availability of cofactors, temperature, and pH. Magnesium (Mg2+) is an essential cofactor: minimal levels are required for basal activity and 1–2 mM Mg2+ for optimal activity (Fig. 1). A large excess of MgCl2 inhibits enzyme activity (Fig. 2). DENARASE® has a temperature optimum of 37 °C and a pH optimum of 8.0 (Fig. 3 & 4).
Effect of Temperature and pH Value
Fig. 1: Effect of temperature
Fig. 2: Effect of pH value in different buffer systems
The Effect of Low and High Magnesium Chloride
Fig. 3: Effect of low magnesium chloride concentrations on DENARASE® activity
Fig. 4: Effect of high magnesium chloride concentrations on DENARASE® activity
Key Characteristics & Optimal Conditions
| Molecular Weight (calculated) | 27 kDa (per monomer) |
| Cofactor | Mg2+ (optimum 1–2 mM) |
| pH Optimum | pH 8.0–9.0 |
| Temperature Optimum | 37 °C |
| Isoelectric Point (pI, calculated) | 6.2 |
Product Specification
In order to ensure a constant and high-quality level for DENARASE®, each batch must fulfill the in-house acceptance criteria for the parameters listed below.
| Criteria | Method | Specification |
|---|---|---|
| Appearance | Visual | Clear, transparent solution |
| Activity | Photometric | > 250 U/µL |
| Purity | Protein purity determined by SDS-PAGE and silver staining | ≥ 99% |
| Specific Activity | Activity per protein content determined photometrically at 280 nm with a molar extinction coefficient of 44,600 L × mol−1 × cm−1 | > 6 × 105 U/mg |
| Protease Activity | Protease detection assay | No protease activity detectable |
| Endotoxin Level | LAL-Test acc. to Ph. Eur. 2.6.14, Method C | < 0.25 EU/kU |
| Total Microbial Count | TAMC/TYMC acc. to Ph. Eur. 2.6.12 | Aerobic bacteria: < 5 cfu/200 µL Yeast/moulds: < 5 cfu/200 µL |
Storage & Conditions
The shelf life of DENARASE® is at least 36 months from the date of manufacture / product release when stored at the recommended temperature of −20 °C ± 5 °C. Note: It is not recommended to store the product at −70 °C or below, as deep freezing will cause loss of activity.
Packaging Information
DENARASE® is filled in non-pyrogenic, USP Class VI compliant vials. Product vials are shipped under qualified cooled conditions. The shipping temperature may differ from the recommended storage temperature without affecting product quality. All DENARASE® products are delivered by c-LEcta in a sealed secondary packaging with tamper-evident seals.
– Reliable and economical DNA clearance across a broad salt spectrum and different pH levels
– High activity to all forms of DNA/RNA
– Produced under GMP conditions in accordance with EU GMP regulations
– R&D- and GMP-grades with equivalent performance available
– Manufacturing free of animal-derived materials, antibiotics and Triton X-100
– Endotoxin-free expression host · One-for-all Serratia marcescens ELISA Kit
A peer-reviewed study on AAV production (Nascimento et al., J. Biotechnology, Vol. 408, 72–79, Dec. 2025, doi: 10.1016/j.jbiotec.2025.09.002) used DENARASE® as a more economical solution compared to Benzonase®. As efficiency depends on buffer composition, dosing, scalability, and downstream design, results may vary — small-scale feasibility testing is recommended.
The estimated delivery time is 2–3 weeks worldwide.
DENARASE® hydrolyzes phosphodiester bonds between nucleotides, leaving ~3–5 bp fragments. Active on all nucleic acid forms (single/double-stranded, linear, circular, supercoiled). Widely used in research, process development, and production of viral vectors and vaccines.
Peak performance at low to physiological salt: for use below 150 mM NaCl. Release assay conditions: 0 mM NaCl / 1 mM MgCl2. Recommended starting concentration: 10–100 U/mL; optimize time, concentration, and temperature for your process.
Viral Vector Production (AAV, Lentivirus / HEK293): added during/after cell lysis to reduce viscosity, degrade nucleic acids, and facilitate downstream purification.
Vaccine Manufacturing (live attenuated, inactivated, VLP): reduces host cell DNA during harvest, enhances robustness, prevents aggregation.
Two grades — both technically equal with the same specification parameters.
R&D grade: ISO 9001; less strict documentation, storage, and distribution requirements.
GMP grade: EU GMP; US FDA Drug Master File support; GDP-compliant distribution.
c-LEcta published a comparative study using the DENARASE® activity release test to directly compare both enzymes — essential for dual-sourcing strategies. Data available via the downloads section. 1 Benzonase Nuclease is a registered trademark of Merck KGaA.
Yes. The DENARASE® ELISA Kit quantifies both DENARASE® and Benzonase® with high sensitivity, strong reproducibility, and proven compatibility as a unified assay for residual Serratia marcescens endonuclease monitoring. 1 Benzonase Nuclease is a registered trademark of Merck KGaA.
Anion exchange, cation exchange, hydrophobic interaction, hydroxyapatite, or size exclusion chromatography. Filtration techniques can also apply. The appropriate media must be evaluated per specific case.
~600 mM NaCl is sufficient. Potassium phosphate (200–300 mM) can also quench activity depending on buffer. EDTA (>5 mM) removes free Mg2+ ions and inhibits the enzymatic reaction.
Yes. All batches must meet the endotoxin specification (<0.25 EU/kU) prior to product release. See the Validation Guide for full details.
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 publicationsResearch budgets are tight — we get it. That's why we've put together a fresh round of exclusive promotions designed to help you stock up on the reagents, kits, and consumables your lab depends on, without stretching your budget.
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