About DENARASE® High Salt

How DENARASE® High Salt works

DENARASE® High Salt is an engineered version of the wild-type Serratia marcescens endonuclease. By introducing a few amino acid substitutions, the enzyme was optimized for salt tolerance. This allows the enzyme to retain its activity at higher salt concentrations without losing specificity for nucleic acids. DENARASE® High Salt exhibits higher DNA removal activity across a broader range of salt concentrations and pH levels. These features provide greater flexibility in bioprocessing and enable seamless integration into existing workflows.

Production of DENARASE® High Salt

DENARASE® High Salt is produced using a method nearly identical to our established, patented DENARASE® manufacturing process, which is based on expression in a gram-positive Bacillus sp. strain. This approach minimizes the risks of endotoxins in the product. Developed for use in commercial production of biologicals, the enzyme is manufactured under GMP conditions in compliance with EU GMP regulations. DENARASE® High Salt is produced without the use of antibiotics, Triton X-100, animal-derived or TSE/BSE risk raw materials.

DENARASE® High Salt is available in two Quality Grades

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DENARASE-High-Salt_R&D-grade
DENARASE-High-Salt_GMP-grade

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

  • DENARASE® High Salt R&D-grade is produced in accordance with the ISO 9001 standard, which has less stringent requirements for documentation, storage and distribution.

  • DENARASE® High Salt GMP-grade is manufactured under EU GMP conditions.

  • From a technical performance perspective, both quality grades are equivalent. This ensures a seamless transition from early R&D stages to biopharmaceutical manufacturing under GMP.

Engineered Innovation that adapts to your Process!

DENARASE® High Salt shows a high DNA removal activity across a wide range of salt concentrations, outperforming other salt-active endonucleases (Salt-E). Especially at pH 7.4 the activity of DENARASE® High Salt is significantly higher than its competitors.

DNA removal activities of commercial salt-active endonucleases (Salt-E)

DNA removal activities of commercial salt-active endonucleases (Salt-E1) assed by
c-LEcta Salt Performance Test. Measured DNA removal activities [UnitTest/μL] were normalized to the applied nuclease units as specified in the manufacturer’s CoAs [UnitCoA/μL] and are depicted as [UnitTest/UnitCoA].

Avoid unnecessary Salt & pH adjustments!

DENARASE® High Salt shows a high activity at salt concentrations that are commonly applied during the harvest step. This avoids the need for salt and pH adjustments to increase endonuclease activity, as required for some of the other marketed salt active enzymes. Maximize your bioreactor capacity – without reserving space for buffer and salt additions. 

 

DENARASE® High Salt – The optimal choice for a flexible and efficient process design!

Order your DENARASE® toolkit now!

Step 1 | Which product?

Choose your DENARASE® enzyme or DENARASE® ELISA Kit.

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.

Products for use in research and development & GMP 
DENARASE® High Salt is designed to retain activity at elevated salt and different pH levels. It is specifically engineered for use in development and manufacturing processes, that benefit from salt additions. The salt-tolerant enzyme efficiently cleaves all forms of DNA and RNA across a broad range of process-relevant conditions, facilitating flexible and more efficient production of biologicals, such as viral vectors and vaccines. 

  • DENARASE® High Salt GMP-grade manufacturing complies with EU GMP standards
  • DENARASE® High Salt R&D-grade is produced under ISO 9001 standard
  • Both quality grades of DENARASE® High Salt are technically equivalent, enabling a seamless transition from early R&D stages to biopharmaceutical manufacturing under GMP

ELISA Kit for detection of DENARASE®, DENARASE® High Salt and Benzonase*
For the quantitative analysis of residual Serratia marcescens endonucleases including DENARASE® High Salt in process samples.

  • The kit consists of a pre-coated micro test plate and all ready to use reagents
  • The capacity of 1 kit is 480 measurements ​
  • Estimated Delivery time: 1-2 weeks (depending on region)​
  • Net price excluding VAT and shipment costs

*Benzonase Nuclease is a registered trademark of Merck KGaA

Step 2 | Order now!

Step 2 | Which quality grade?

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 10-100 U/ml is needed ​
  • Net price excluding VAT and shipment costs
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

Step 2 | Which quality grade?

Intended for use in process development of biologicals such as viral vectors and vaccines. The salt-tolerant enzyme cleaves all forms of DNA and RNA and enables a simpler, more efficient downstream process at salt concentrations above 150 mM. 

Purity: ≥ 98% 
Activity: > 250 U/µl 
Formulation: buffered aqueous glycerol solution 
Storage Temperature: -20°C 
Estimated Delivery time: 1-2 weeks (depending on region) 

  • Produced under ISO 9001 standard
  • Manufactured without the use of antibiotics, Triton X-100 and raw materials of animal origin
  • Depending on your application 10-100 U/ml enzyme is needed
  • Net price excluding VAT and shipment costs 

Intended for use in GMP manufacturing of biologicals such as viral vectors and vaccines. The salt-tolerant enzyme cleaves all forms of DNA and RNA and enables a simpler, more efficient downstream process at salt concentrations above 150 mM. 

Purity: ≥ 98% 
Activity: > 250 U/µl 
Formulation: buffered aqueous glycerol solution 
Storage Temperature: -20°C 
Estimated Delivery time: 1-2 weeks (depending on region)

  • Manufacturing of the GMP-grade DENARASE® High Salt complies with the same stringent regulations and standards as the wild-type GMP-grade DENARASE® products.  
  • Produced under GMP conditions complying with EU GMP regulations 
  • Manufactured without the use of antibiotics, Triton X-100 and raw materials of animal origin 
  • Net price excluding VAT and shipment costs 

Step 2 | Order now!

A powerful enzyme for DNA removal."

Step 4 of 4 | Confirm your order

Step 3 | Which product size?

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Step 3 | Which product size?

Step 4 | Request price

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Step 3 | Which product size?

Step 4 | Order now!

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Step 4 | Order now!

Step 4 | Order now!

Step 4 | Order now!

Step 3 | Which product size?

Step 4 | Request price

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Ready to elevate your Viral Vector Bioprocessing?

DENARASE® expert team

DENARASE® - Your complete toolkit for DNA removal 
Pick the DENARASE®  version that maximizes efficiency for your process.

c-LEcta-DENARASE-ELISA-Kit

The One-for-all Serratia marcescens ELISA Kit!

For the quantification of residual Serratia marcescens endonucleases including DENARASE® High Salt.

Development of DENARASE®

2025

Launch of the DENARASE® High Salt GMP-Grade

Following the introduction of the R&D grade in March 2024, DENARASE® High Salt is now also available as GMP-grade. Manufactured under EU GMP conditions, this quality grade ensures compliance with the highest regulatory standards. With its enhanced activity across a broad spectrum of salt concentrations, DENARASE® High Salt GMP grade meets stringent quality requirements and offers maximal flexibility for clinical and commercial stage processes that benefit from elevated salt conditions.

250313_DENARASE High Salt_history slider

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

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

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

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

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

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

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

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

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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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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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!

Sedef Ozyurek

Sedef Ozyurek
DENARASE® Sales

Need support? Contact me!