Cell Factory - Officina Farmaceutica
Cell Factory – Pharmaceutical Facility “University of Turin”
This document describes the activities of the Pharmaceutical Facility (Cell Factory) at the Molecular Biotechnology Center (MBC), University of Turin, located at Via Nizza 52, Turin.
The Cell Factory has been operating since 2008, with:
- Three Class B clean rooms for cell therapy
- One Class B clean room for gene therapy
In July 2017, the Cell Factory obtained authorization from AIFA (Italian Medicines Agency) to conduct its activities.
The facility has implemented a quality system based on EuGMP standards (European Good Manufacturing Practices). It is dedicated to the production of:
- Sterile investigational medicinal products, prepared under aseptic conditions
- Adult stem cells for clinical applications in cell therapy and gene therapy
Cells intended for clinical applications must be cultivated following GMP standards, which are the same regulatory guidelines adopted by pharmaceutical industries for drug manufacturing. According to recent European regulations, cell culture-derived products fall under the category of Advanced Therapy Medicinal Products (ATMPs).
The Cell Factory is currently used for the preparation of human liver stem cells (HLSCs) for cell therapy in patients with acute liver failure. This is part of a Phase I clinical study titled:
"Human Liver Stem Cells (HLSCs) in Adult Patients Affected by Acute Liver Failure (ALF) and Ineligible for Liver Transplantation."
To enable additional experimental activities, a new master cell bank of HLSCs has been established in collaboration with the University Transplant Center of Città della Salute, along with a master cell bank of mesenchymal cells. The facility’s capabilities may be expanded to include the preparation of microvesicles for therapy.
The development and activation of the Cell Factory allow for the conduct of clinical trials and treatment of various diseases, including genetic disorders. Furthermore, it represents a strategic asset that should be further developed to support new lines of translational research, bridging basic research, preclinical studies, and clinical applications.
Applicazioni e Servizi
L’attività di produzione è costituita da:
- Produzione di medicinali sperimentali sterili, preparati in asepsi, per terapia avanzata (ATMP)
I test condotti nel laboratorio Controllo Qualità interno sono i seguenti:
- Test di Potency
- Conteggio e vitalità cellulare
- Test di identità
- Test di impurezza
Accesso e tariffario
È possibile accedere all’infrastruttura su prenotazione, accompagnati da personale autorizzato.
Le tariffe sono definite in funzione delle richieste specifiche.
Dove
- Centro per le Biotecnologie Molecolari (MBC)
- Dipartimento di Biotecnologie Molecolari e Scienze per la Salute
Via Nizza, 52 – 10126 Torino