The Lugano Cell Factory is a site of 250 square meters including a Clean Room (map above), a Quality Control area and a R&D area.
The Clean Room consists of:
•3 class B production laboratories
•1 class C production laboratory
•1 class C warehouse
•class C and D access rooms
The production rooms are fully equipped for aseptic processing and in vitro culture.
The main environmental parameters of the Clean Room (humidity, temperature, pressure, airborne viable and non-viable particulate) are constantly monitored by a computerized control system.
- 1. GMP manufacturing of Cell Therapy and Tissue Engineering Products
- cell isolation from tissues (bone marrow, adipose tissue, peripheral blood…)
- set-up of primary cultures
- long term cultures in normal and hypoxic conditions
- large scale cell cultures
- concentration and purification of cell-derived products (microvesicles)
- 2. Quality control assays according to GMP standards
- Flow cytometry for surface markers, viability, apoptosis, cell cycle, rare cells… (EuPh 2.6.29 and EuPh 2.6.24)
- Real time PCR
- ELISA testing for cytokine, antibody and drug dosage in biological fluids
- Sterility testing (EuPh 2.6.1 and EuPh 2.6.27)
- Bacteria identification
- Endotoxin test (EuPh 2.6.14)
- Cell based assays (clonogenic potential, invasion, proliferation, cytoxicity …)
- 3. High quality services for research and clinical studies
- Cell banking
- Plasma and serum preparation
- Cell isolation from tissue biopsies, bone marrow and peripheral blood
- Storage of cells and biological fluids
- Microbiological monitoring of the laboratory environment
- 4. Consultancies ‘from R&D to ATMP’
- LCF gives consultancies on GMP requirements and regulatory issues to clinical and research entities who need to bring up the quality of their productions to the GMP level.