Midatech Biogune S. L., the nanoparticle manufacturing subsidiary of the Midatech Group, has announced that it has been granted an Investigational Medicinal Products (IMP) License from the Spanish Medicines Agency for the cGMP manufacture of clinical grade nanoparticles at its facility in Bilbao, Spain.
Inspectors from the Spanish Medicines Agency carried out an inspection of the Midatech Biogune facility on the 15th and 16th of February 2011 and thereupon granted the accreditation, making Midatech one of the first companies in Spain to be granted this type of license under the new European regulations.
Justin Barry, CEO, said; "Getting such a rapid and positive response from the Medicines Agency validates the quality of our manufacturing and endorses the investment that Midatech has made into its first class quality systems.”
Tom Rademacher CEO and Chairman of the Midatech Group, added; “This is great news for colleagues in Spain, and for Midatech globally. It marks a critical stage in the Company’s history in our development as a clinical stage company, with our novel insulin formulation approaching first-in-man trials.”