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QA Manager & Qualified Person Kedrion Biopharma Orphan Drug Facility
Kedrion Biopharma and TLS cross paths in 2011 and find a common ground in sustaining research for orphan disease. Kedrion, the fifth player worldwide in plasma-derived therapeutic products, has localized a plant dedicated to research and development of orphan drugs in TLS, within a project between Kedrion, the Regione Toscana and Toscana Life Sciences Foundation. In 2014 Kedrion promoted a complete renovation of the site to upgrade to the plasma authority requirements. As shared with us in this interview by the Quality Assurance Manager of the site, Lorenzo Terranova, the path for authorizing a pharmaceutical site is long and complex because one must demonstrate the adherence to GMP requirements, the European guidelines that regulates the pharma production and the basis of the quality system of a pharma company. On 6 October 2015, after a long preparatory stage, the Italian Pharma Agency (AIFA) authorized the IKOD site in Siena to produce plasma-derived therapeutic products for clinical trials. Starting in 2015, the site has participated in four Kedrion R&D projects with the production of numerous batches on a pilot scale. At the same time, to render the site more independent from an analytical point, Kedrion set up new Quality Control labs inside the TLS incubator, authorized by AIFA in May 2016.