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European Biopharmaceutical Review

Endonuclease Compliance

A novel fermentative process, free of animal-based derivatives, uses endotoxin-free Bacillus amyloliquefaciens to economically produce the endonuclease from Serratia marcescens in high quantities. The new derivative is the first current Good Manufacturing Process (cGMP) product of its type, allowing its use in red biotechnology without regulatory restrictions.

Nucleases comprise a broad family of hydrolases that cleave nucleic acids. Several biotechnological applications have been reported, for example, in removing nucleic acids in biosynthetic processes to reduce viscosity associated to cell disruption or in the cost-effective elimination of nucleic acid impurities of a final (biosynthetic) product to comply with tight safety regulations. The production of the endonuclease from S marcescens has recently been successfully demonstrated in Bacillus subtilis − a gram-positive, endotoxin-free bacterium. Moreover, the fermentation is conducted in the absence of animal-based derivatives, thus, the novel derivative is an animal-free ingredient without the risk of bovine spongiform encephalopathy and transmissible spongiform encephalopathy (BSE/TSE). On that basis, the new endonuclease fulfils all cGMP requirements and may significantly broaden the applications of nucleases in biopharmaceuticals, promoting new markets and stimulating established ones.

Applying Nucleases

Nucleases are hydrolases that cleave the phosphodiester bonds between monomers of nucleic acids (DNA and RNA), digesting them into smaller oligonucleotides. In nature, they are responsible for the proper maintenance of nucleic acids in cells, keeping the genetic quality control and being actively involved in DNA replication and reparation. Some unspecific nucleases display the cleavage of all forms of nucleic acids, namely DNA and RNA, single- or double-stranded, linear or circular, and without any defined sequence-specificity. In the realm of red biotechnology and molecular biology sciences, such nucleases have become useful biocatalysts for a broad number of applications. A remarkable example is the purification of biopharmaceuticals – for instance, biosynthesised proteins, vaccines, etc – by removing the nucleic acid impurities generated along the bioprocess, thus saving costs associated to the downstream processing and purification units. Another useful application is the reduction of viscosity in biological samples caused by the presence of nucleic acids when cells are disrupted during the work-up steps.

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Dr Pablo Domínguez de María holds BScs in pharmacy and chemistry and a PhD in biocatalysis. He worked in the industry for 6.5 years at Evonik from and AkzoNobel BV, being involved in projects related to sustainable chemistry, organocatalysis, biorefineries, and biotech. In 2009, Pablo joined the RWTH Aachen University, Germany, as group leader, defending his habilitation in 2015. Since 2014, he is the CEO of Sustainable Momentum, a consultancy firm providing technical support in areas related to biorefineries, biotech, and sustainable chemistry. He has delivered several technical books, is co-inventor of some patents, and has published more than 100 scientific publications.

Dr Stefan Schoenert is Head of Strain and Process Development at c-LEcta. He was the developer of DENARASE nuclease and is responsible for development and improvement of biotech-relevant expression systems based on microorganisms including Bacillus sp, E coli, and Pichia pastoris and their use in production of enzymes and organic chemicals. Stefan has a PhD in biology from the University of Konstanz, Germany.
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Dr Pablo Domínguez de María
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Dr Stefan Schoenert
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