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DSM, Novacta Biosystems Sign C difficile cGMP Production Agreement

DSM BioSolutions (DSM) has signed an agreement with C. difficile for the process development and cGMP production of its C difficile molecule, a new class of lantibiotic compounds.

Novacta Biosystems, a UK-based biotechnology company controlled by Celtic Pharma, is focused on bringing new and modern anti infective therapies to the market.

DSM it has 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 equipped for the production of biologically active compounds produced via microbial fermentation and has experience in both bacterial and fungal fermentation.

Villaume Kal, vice-president of DSM, said: “Our technology and 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, said: “We have chosen to work with DSM as it has an impressive track record for scaling up fermentation processes for antibacterial agents from actinomycetes.”