DENARASE® is a genetically engineered endonuclease originating from the micro-organism Serratia marcescens. The enzyme is used for the digestion of nucleic acids in production processes of biological molecules.
Released DNA from the host cell forms a challenge in the downstream processing of biological molecules. The nucleic acids cause an increase of the fluid viscosity and DNA-fragments may stick to the target molecule. This leads to lowered filter capacities and reduced recovery rates of columns. DENARASE® reduces the DNA level at an early stage of the process, which improves overall DSP economics.
Denarase is especially successful in applications where the product is expressed in the host cell. Cell lysis not only releases the product but also all nucleic acids in the host cell. Successful applications of DENARASE® include the purification of vaccines, proteins expressed in inclusion bodies and monoclonal antibodies.
The production of the enzyme is based on recombinant expression in a Bacillus sp. production host. The Gram-positive production strain is free of endotoxins.
The complete manufacturing process including packaging and Quality Control is in full compliance
with the EU cGMP requirements.
DENARASE® endonuclease is produced by using solely raw materials which are not derived from animal origin.
|Primary Product Type||
Clear, transparent solution
< 0,25 EU/kU
No protease activity detectable
|Total microbial count||
Aerobic bacteria: < 5 cfu; yeast/moulds: < 5 cfu. Method: Colony forming units per 200 μl enzyme solution