GMP compartment (white room system)
Short description:
The 150 sqm area meets all the requirements for processing biological materials under GMP (good manufacturing practice) conditions specific to the drug industry and other therapeutic products. This area includes 3 class A workplaces placed in Class B rooms (ISO 5), where environmental conditions are permanently monitored (minimum particle number, absence of any bacterial load, temperature, humidity, pressure, high performance, HEPA-like, air filtration) and access is strictly restricted for specialist staff.
Main activities / techniques:
The extremely high standards of these spaces will ensure the following applications:
- antitumor immunotherapy
- the creation of personalized therapeutic combinations for cancer patients
- innovative therapies in immune diseases
- isolation and expansion of cell types with application in regenerative medicine under controlled conditions
Staff:
- Coordinator: Gabriela Tanasie, MD, PhD
- Responsible for quality control
- Responsible for quality assurance
- Responsible for production
- Technician
Equipment:
- Laminar flow hoods
- CO2 Incubators
- Refrigerators and freezers
- Centrifuges
- CliniMACS clinical cell separator
- Freeze dryer
- Grooming machine for bone tissue