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.
