DENARASE® highly active endonuclease from Serratia marcescens
Dodavatel: C-LECTA GMBH
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).
Certifikace: 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
Informace o dodávce: 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.
Balení: 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.
Upozornení: 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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