Ark Therapeutics Group has opened its new commercial-scale manufacturing facility in Kuopio, Finland.
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The facility, built as a result of a co-operative agreement between the company and the University Business Park, is an advanced construction, linked to Ark’s existing manufacturing and laboratory suites. It has been specifically designed for the manufacture of gene-based medicines, particularly those in viral vector constructs, and will operate to Biosafety Level Two (BSL2).
The facility will initially be used for laboratory and pre-clinical grade production while equipping and validating dedicated production theatres to enable full GMP certification.
According to the company, this facility adds to the capabilities of its existing production units (GMP 1 and GMP 2) and will allow the company to be fully self-sufficient for manufacture of all the gene-based products in its portfolio, including Cerepro (for glioblastoma) and Trinam (for haemodialysis graft access surgery), for research, clinical trial and commercial supply.
Robert Shaw, technical director at Ark, said: “This is a very high grade facility which is complementary to Ark’s existing manufacturing capabilities in Kuopio and enables the company to take advantage of the quality science and technology in Finland.”
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