[No.002] Denarase (for manufacturing under GMP)
About DENARASE® High Salt
How it works
DENARASE® High Salt is an engineered version of the wild-type Serratia marcescens endonuclease, which is commonly used for DNA removal applications in bioprocessing. Compared to the wild-type DENARASE® a few amino acids were substituted to provide the enzyme with an improved salt tolerance without losing its specificity for nucleic acids. DENARASE® High Salt shows higher activity over a wider range of salt concentrations and pH levels and so offers greater flexibility in bioprocessing.
Because of the great similarities to the wild-type enzyme, DENARASE® High Salt can be detected using the same Serratia marcescens endonuclease ELISA Kits, such as DENARASE® ELISA Kit.
Production of DENARASE® High Salt
DENARASE® High Salt is produced using our established, proprietary DENARASE® manufacturing process which is based on the expression in a gram-positive Bacillus sp. strain. The enzyme is produced under ISO 9001 standard, without the use of antibiotics and raw materials of animal origin or TSE/BSE risk.
More information: c-lecta.com
SPECIFICATION
DENARASE® High Salt GMP for biopharmaceutical manufacturing
The launch of the DENARASE® High Salt GMP grade for use in commercial manufacturing processes of biologicals is scheduled for Q2 2025.
- The manufacturing process of the High Salt GMP-grade will comply with the same regulations and standards as our well-known wild-type GMP-grade DENARASE® products.
- Produced under EU GMP conditions.
- Manufacturing free of animal-derived raw materials, Triton X-100 and antibiotics
- From a technical performance perspective, DENARASE® High Salt R&D- and GMP-grade will be equal.
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