The Clean Room
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.
LCF offers to business, clinical and research groups services for product development, process development and establishment of quality controls methods.
- 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.
First Stem Cell Transplant in the heart i Switzerland was conducted at Cardiocentro Ticino
Cardiocentro set up a Clean Room, QC lab and Quality System as part of its facilities.
Swissmedic gives the Certification to operate as Cell Factory for Tissue engineering products, autologous and fresh
Swissmedic Certification was extended for Cell Therapy products, allogenic and frozen
Clean Room capacity improvements are developed for long-term cultures and large scale processes
Swiss Federal Office of Publich Health gives the authorization to operate as Cardiovascular Tissue Bank