Kind of infrastructure
Platforms/Labs
Typology
Biology / genomics / proteomics
University
Torino (UNITO)
Application / Industrial sector
Health
Description of equipment
The Cell Factory (CLF) is located at the Molecular Biotechnology Center (MBC) of the University of Turin, and it is specializes in the production in GMP of ATMPs, biological drugs, extracellular vesicles, and in the formulation of Class I and II biological medical devices.
CLF bases its business on a multipurpose service offering model and proprietary product development. The main activities and services include:
• Technology transfer and GMP process development
• GMP production of ATMPs for Phase I and Phase II clinical trials
• Development and validation of QC analytical methods
• QA activities, process control and batch release
• Advice on GMP documentation
• Advice on GCP documentation for clinical trial authorisation.
Location
Department
Department of Molecular Biotechnology and Health Sciences
Features
Equipment list
LAB-0074 Pharmaceutical Lab.
The Pharmaceutical Lab consists of 3 class B laboratories, 1 laboratory set up for class B gene therapy, currently used as a quality control laboratory.
The workshop is used for the preparation of sterile experimental medicines, prepared in asepsis, for advanced therapy (ATMP). The quality system is based on EuGMP standards consisting of prescriptive documentation (management procedures, operating and work instructions, etc.) and registration documentation (batch records, equipment log book, raw data registration forms, etc.).
The Pharmaceutical Lab consists of 3 class B laboratories, 1 laboratory set up for class B gene therapy, currently used as a quality control laboratory.
The workshop is used for the preparation of sterile experimental medicines, prepared in asepsis, for advanced therapy (ATMP). The quality system is based on EuGMP standards consisting of prescriptive documentation (management procedures, operating and work instructions, etc.) and registration documentation (batch records, equipment log book, raw data registration forms, etc.).
Available measurements
APPLICATIONS AND SERVICES
The production activity consists of:
- Production of sterile, aseptically prepared experimental drugs for advanced therapy (ATMP)
The tests conducted in the internal Quality Control laboratory are as follows:
- Potency test
- Cell count and viability
- Identity test
- Impurity test
The production activity consists of:
- Production of sterile, aseptically prepared experimental drugs for advanced therapy (ATMP)
The tests conducted in the internal Quality Control laboratory are as follows:
- Potency test
- Cell count and viability
- Identity test
- Impurity test
Price list
It is possible to access the infrastructure by reservation, accompanied by authorized staff, and / or send samples for analysis (without directly accessing the structure). The technical feasibility of the request is evaluated and the experiments. Rates are defined according to specific requests.
Other relevant information
Other contacts:
Valentina Fonsato: valentina.fonsato@unito.it
Valentina Fonsato: valentina.fonsato@unito.it
Contact
Person name
Fiorella ALTRUDA
Email
fiorella.altruda@unito.it