CAPUA, Italy, June 9 /PRNewswire/ -- DSM BioSolutions today announced that it has entered into an agreement with Novacta Biosystems Limited, Welwyn Garden City, UK, for the process development and cGMP production of its C. difficile molecule, a new class of lantibiotic compounds.
DSM has successfully completed the process development and commenced cGMP-manufacturing of the Novacta compound at its microbial fermentation biotech facility located in Capua, Italy. The product will initially be used for pre-clinical and phase I clinical trials. DSM's Capua facility is uniquely equipped for the production of biologically active compounds produced via microbial fermentation and has extensive experience in both bacterial and fungal fermentation.
Villaume Kal, Vice-President of DSM BioSolutions stated, "We are excited to work with Novacta Biosystems, an innovative and progressive biopharmaceutical company developing treatments for infectious diseases. Our technology, operational excellence and outstanding cGMP and compliance record with the FDA allows us to serve this important customer and to produce their clinical trial material."
Mike Dawson, CSO of Novacta stated, "We have chosen to work with DSM as it has an impressive track record for scaling up fermentation processes for antibacterial agents from actinomycetes."
No financial terms will be disclosed.
Novacta Biosystems, a UK biotechnology company controlled by Celtic Pharma Holdings, is focused on bringing new and modern anti infective therapies to the market. The company is committed to developing a new generation of agents with improved resistance profiles to combat the growing issue of hospital based infection. Using its proprietary lantibiotic platform a number of agents are being evaluated for C. difficile, Gram-positive and Gram-negative pathogens. For more information, please visit www.novactabio.com.
DSM BioSolutions – Microbial Fermentation
DSM BioSolutions, part of the DSM Pharma cluster, offers a wide range of customer services ranging from process development to large scale production, all in the field of microbial fermentation. Expertise covers microbial strain construction and improvement, fermentation process development and product recovery and purification. DSM's production infrastructure for fermentation and associated product recovery and purification is based in a multipurpose facility in Capua, Italy, which currently produces pharmaceutical intermediates and APIs (with the exception of beta-lactams) and food/nutrition-related products. In the pharma area, production lines are available for cGMP manufacturing of small molecules and pharmaceutical proteins. The facilities comply with all relevant regulations and are regularly inspected by the respective authorities (e.g. FDA). More information: www.dsmbiosolutions.com
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about euro 8 billion and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.
For more information:
Vice President of Corporate and Business Development
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Sr. Director New Business Development
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This press release may contain forward-looking statements with respect to DSM's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.
SOURCE DSM BioSolutions