Officina Farmaceutica "Università degli studi di Torino"

The Cell Factory (CLF) "Università degli studi di Torino", based at the Molecular Biotechnology Center (MBC) of the University of Turin, is specialized in the GMP production of ATMPs, biologics, extracellular vesicles and in the formulation of Class I and class II Biological Medical Devices. The CLF staff is higlly qualified and continuously itrained and retrained. They have matured decades of experience in isolation and culture of stem and adult cells, as well as in isolation of extracellular vesicleusing different techniques, including the Tangential Flow Filtration . The CLF offers services based on a multipurpose model and develop proprietary products. Core activities and services include: • Tech Transfer and GMP Process Development • GMP production of ATMPs for Phase I and Phase II clinical studies • Set up, and validation of analytical methods and QC tests • QA activities, In Process and Batch Release Control • Consultancy on GMP-compliance documentation • Consultancy on GCP-compliance documentation for Clinical Trial authorization CLF maintains a close collaboration with R&D laboratories located in the Centre, in particular with the Stem Cells and Regenerative Medicine Laboratory. A multidisciplinary network is also established with external organisations such as the “Città della Salute e della Scienza di Torino”, the hospital center that allows the collaboration with clinicians for the development of new Clinical Trials, mainly Phase I and Phase II. International sponsors support CLF commissioning the development and production of GMP Products in the field of regenerative medicine.