Finding a Cure, for Even One Patient
Kedrion Biopharma and TLS crossed paths in 2011 and found a common ground in sustaining research for orphan diseases. Kedrion, the fifth player worldwide in plasma-derived therapeutic products, has set up a plant dedicated to research and development of orphan drugs in TLS, within a project involving Kedrion, the Region of Tuscany and the Fondazione Toscana Life Sciences. 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 process for authorizing a pharmaceutical site is long and complex because one must demonstrate adherence to GMP requirements, the European guidelines that regulate pharma production and the basis of the quality system of a pharma company. On October 6, 2015, after a long preparatory stage, the Italian Medicines Agency (AIFA) authorized the IKOD site in Siena to produce plasma-derived therapeutic products for clinical trials. Starting from 2015, the site has participated in four Kedrion R&D projects with the production of numerous pilot scale batches. At the same time, to render the site more independent from an analytical perspective, Kedrion set up new Quality Control labs inside the TLS incubator, authorized by AIFA in May 2016.
For more information: www.kedrion.com