DENARASE® highly active endonuclease from Serratia marcescens

Supplier: C LECTA

20804-100K 20804-500K 20804-1M 20804-5M 20804-5000K 20804-1000K
20804-100KEA 455 EUR
20804-100K 20804-500K 20804-1M 20804-5M 20804-5000K 20804-1000K
DENARASE® highly active endonuclease from Serratia marcescens
Enzymes

DENARASE® is a highly active endonuclease from Serratia marcescens. This enzyme is used in biopharmaceutical manufacturing to eliminate plasmid and host cell DNA/RNA. DENARASE® is manufactured under GMP conditions and is widely applied during the purification of viral vectors for gene/cell therapies and vaccines.


  • DENARASE® is available in two quality grades: DENARASE® for Research and Development (R&D) use and DENARASE® for manufacturing under GMP
  • 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
  • In order to avoid mix-ups, packaging units of the same size are indicated differently in the product name of the two quality standards: 1000/5000 kU for R&D-grade DENARASE® and 1/5 MU for GMP-grade DENARASE®


DENARASE® has a high purity of ≥99% and is manufactured free of animal derived raw materials and antibiotics. 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® 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).


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.


Temperature optimum: 37 °C
Magnesium optimum: 1-5 mM
Isoelectrical point: pH 6.2
Salt: 0-200 mM


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).
The products DENARASE®, 25 kU, DENARASE®, 100 kU and DENARASE®, 500 kU (Article Numbers: CLEC20804-25K, CLEC20804-100K, CLEC20804-500K) are intended for use in research and development. They are produced under GMP and filled under ISO 9001.
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).


Certifications: Produced under EU GMP conditions in Germany
Certified compliance with the EXCiPACT and ANSI NSF 363 Standard (meeting GMP for pharmaceutical excipients)
Dedicated regulatory support for US-market approvals of pharmaceutical products via own US FDA Drug Master File


Delivery information: DENARASE® is shipped by default in insulated boxes with cold packs as a precautionary measure to protect against unexpectedly elevated temperatures during transport. Storage at -20 °C ± 5 °C is recommended upon receipt of the product.


Packaging: DENARASE® is filled in non-pyrogenic, USP Class VI-compliant vials. The product vials are packed in polystyrene boxes and shipped under refrigerated conditions. Shipping temperature may differ from storage temperature without affecting product quality.


Caution: DENARASE® is stable within the specification range at a storage temperature of -20 °C for a period of at least 24 months from the date of product release.
Note: It is not recommended to store the product at -70 °C or below, since freezing the product will cause loss of activity.

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SPECIFICATIONS

Enzyme name DENARASE DENARASE DENARASE
Environmentally Preferable
Source
Species Serratia marcescens Serratia marcescens Serratia marcescens
Molecular weight 27 kDa (per monomer) 27 kDa (per monomer) 27 kDa (per monomer)
Purity ≥99% ≥99% ≥99%
Storage conditions Store at −20 °C Store at −20 °C Store at −20 °C
Enzyme activity >250 U/µl >250 U/µl >250 U/µl

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