DENARASE® is a highly active endonuclease from Serratia marcescens. This enzyme is widely used in biopharmaceutical manufacturing to quantitatively eliminate host cell DNA and RNA during the production of biologicals and vaccines, as well as for viscosity reduction in biotechnology applications.
- To meet regulatory requirements, residual DNA must be removed from biotech products. DENARASE breaks DNA chains into fragments of 2–5 bases, making it an efficient DNA removal technology
- DNA can bind to target products such as monoclonal antibodies and viruses: Blocking of functional groups needed for affinity may result in lower recovery rates after chromatography steps; DENARASE® reduces the DNA content at an early stage of the process, thus increasing product yields
- High DNA concentrations cause high viscosities, rendering filtration and chromatography difficult: DENARASE® helps to reduce viscosity and to improve process economics
- DENARASE® can prevent cell clumping in bioreactors
DENARASE® has a high purity of ≥99% and is manufactured in full compliance with cGMP requirements, without the use of antibiotics and only with raw materials of non animal origin. 'to the new wording' DENARASE® has a high purity of ≥99% and is manufactured in full compliance with GMP requirements, without the use of antibiotics and only with raw materials of non animal origin.
The patent-protected production process is based on the recombinant expression in a Bacillus sp., combining high product yields with the advantages of an endotoxin-free production strain. DENARASE® meets all relevant safety and quality requirements for the use in regulated fields.
DENARASE® is a proprietary product of c-LEcta GmbH, Germany.
The products DENARASE®, 1 MU and DENARASE®, 5 MU (Article Numbers: 20804-1M, 20804-5M) are produced and filled under cGMP and are suitable for biopharmaceutical manufacturing applications. 'to the new wording' The products DENARASE®, 1 MU and DENARASE®, 5 MU (Article Numbers: 20804-1M, 20804-5M) are produced and filled under GMP and are suitable for biopharmaceutical manufacturing.
The products DENARASE®, 25 kU, DENARASE®, 100 kU and DENARASE®, 500 kU (Article Numbers: 20804-25K, 20804-100K, 20804-500K) for biotechnology applications are produced under cGMP and filled under ISO 9001. 'to the new wording' The products DENARASE®, 25 kU, DENARASE®, 100 kU and DENARASE®, 500 kU (Article Numbers: 20804-25k, 20804-100k, 20804-500k) are intended for use in research and development. They are produced under GMP and filled under ISO 9001. Please leave a blank line. Then the following sentence should be added. DENARASE® is a registered trademark of c-LEcta GmbH in the European Union (EU), United States of America (USA), China (CN), India (IN), South-Korea (KR) and Japan (JP).