Officina Farmaceutica "Università degli studi di Torino"
Pharmaceuticals - Turin, Piedmont, Italy
Officina Farmaceutica "Università degli studi di Torino" Employees
Officina Farmaceutica "Università degli studi di Torino" Details
The Cell Factory (CLF) "Università degli studi di Torino" is based at the Molecular Biotechnology Center (MBC), University of Turin, located in Via Nizza 52, Turin.GMP production within CLF is tailor-made customized, ranging from pure Biological Medicines, with a focus on ATMPs, to the formulation of Class I and II Biological Medical Devices.It first obtained authorisation (n° aM-138/2017) for the production of Advanced Therapy Medicinal Products (ATMPs) from the Italian medicines' agency AIFA in 2017, which was further renewed in 2020 (n° aM-83/2020).The surface of the classified areas consists of three Grade B Suites, actually working to obtain an additional Production suite by transferring and expanding the Quality Control laboratory in a closed selected area.The CLF build its business on a multipurpose model. Core activities and services include:• GMP production of ATMPs, Phase I and Phase II.• Tech Transfer and GMP Process Development• In Process Control and Batch Release Control .• Set up, execution and validation of analytical methods and QC tests.• QA and Batch Release• Consultancy on GMP-compliance documentation.• Consultancy on GCP-compliance documentation for Clinical Trial authorization.The CLF personnel are very well qualified with decades of experience in isolation and culture of stem and adult cells. Continuous professional development of all personnel is maintained.CLF maintains very close collaborative relations 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" hospital complex which strategically allows collaborating with clinicians for the development of new Clinical Trials, mainly Phase I and Phase II.International Sponsor support CLF commissioning the development and production of GMP Products.
