For cGMP manufacture at facility in Bilbao
Midatech Biogune, the nanoparticle manufacturing subsidiary of the Midatech Group, has been granted an Investigational Medicinal Products (IMP) licence from the Spanish Medicines Agency for the cGMP manufacture of clinical grade nanoparticles at its facility in Bilbao, Spain.
The Spanish Medicines Agency carried out an inspection of the Midatech Biogune facility in February and granted the accreditation. Midatech is one of the first companies in Spain to be granted this type of licence under the new European regulations.
Tom Rademacher, chief executive and chairman of the Midatech Group, headquartered in Abingdon in the UK, said: ‘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.’
The Midatech Group designs, synthesises and manufactures biocompatible nanoparticles, which can be used to create a variety of products with novel characteristics, functions and applications for the life sciences, electronics and fine chemicals industries.