c-LEcta’s DENARASE® Removes Nucleic Acids in Pharmaceutical Processes

c-LEcta, a German biotech company located in Leipzig, has developed an advanced nuclease product, DENARASE®, designed for nucleic acid removal in biopharmaceutical production processes.

Unlike other nuclease types, which usually are produced using Escherichia coli as expression host, c-LEcta’s DENARASE is manufactured using a patent protected production process based on a Bacillus strain and a fermentation medium free of any antibiotics and animal derived products.  Beside the absence of endotoxins in gram-positive bacteria like Bacillus and the absence of antibiotics and animal derived products, the production process is in full compliance with cGMP guidelines. Therefore

DENARASE® can eliminate host cell DNA/RNA impurities from bioprocesses. Biopharmaceutical companies – especially in the field of vaccine manufacturing – have spent a lot of effort and money to remove host cell nucleic acid impurities from fermentation batches. The total downstream processing costs are often 80% to the total manufacturing cost. With respect to the BSE/TSE safety issue, purification processes ideally should be without any animal-derived products. DENARASE® helps manufacturers with both of these concerns.

DENARASE is manufactured under CGMP conditions using an endotoxin-free production strain and only employs raw materials of nonanimal origin. Furthermore, no antibiotics are applied in the whole process starting with the working cell bank generation. DENARASE®  cleaves all forms of DNA and RNA in an unspecific way (single-stranded, double stranded, linear, and circular, sequence-independent) very efficiently and is long-term stable at room temperature. Additionally, it is active in all commonly used buffers in the presence of both ionic and nonionic detergents as well as many reducing and chaotropic agents. With DENARASE® manufacturers can implement an efficient enzyme-based purification process to remove nucleic acids while meeting regulatory requirements.

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