DENARASE® from Serratia marcescens

Lieferant: c-LEcta
20804-5000KEA 6420 EUR
20804-5000K 20804-5M 20804-1M 20804-500K 20804-100K
DENARASE® from Serratia marcescens
Enzyme
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.

  • To meet regulatory requirements, residual DNA must be removed from biopharmaceutical products. DENARASE® breaks DNA and RNA into fragments of 3 to 5 bases, making it an efficient DNA removal technology
  • Enzymatic degradation of DNA and RNA as an early step during purification also helps to increase the yield of biopharmaceutical products. Digested DNA can be removed easier and results in reduced aggregation of biopharmaceutical products such as viral vectors.
  • High DNA concentrations cause high viscosities, rendering filtration and chromatography difficult: DENARASE® helps to reduce viscosity and to improve process economics
  • For process development and quality control purposes, the DENARASE® ELISA kit (available separately, Article Number: 41901-1) can be used to monitor the removal of DENARASE® or similar endonucleases.bioreactors

DENARASE® meets all relevant quality requirements for the use in biopharmaceutical manufacturing:
•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

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.

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) are intended for use in research and development. They are produced under GMP and filled under ISO 9001.

DENARASE® is a proprietary product of c-LEcta GmbH, Germany.

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.

DENARASE® is a proprietary product of c-LEcta GmbH, Germany.

The products DENARASE®, 1 MU and DENARASE®, 5 MU (Article Numbers: CLEC20804-1M, CLEC20804-5M) are produced and filled under GMP and are suitable for biopharmaceutical manufacturing.

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).
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