Biosafety Testing: from cell to medicine
A complete range of regulatory tests in compliance with GLP and cGMP, with more than 150 qPCR tests available. Regulatory support for EMEA, FDA, ICH and the ability to develop and validate innovative, sensitive, specific and robust tests in accordance with ICH Q2 R1 .
Characterisation, safety of cell banks (eukaryotic & prokaryotic)
Biological safety of virus banks
Viral safety of intermediary products
Safety of the final product (batch release)
- Sterility tests and mycoplasma tests
- Identity tests (isoenzyme and PCR)
- Karyotype analysis
- Research for adventitious virus in vitro/in vivo
- Research for retrovirus (direct/infectivity) – qPERT
- Electron Microscopy
- qPCR and RT-qPCR for the specific detection of viruses and other contaminants
- Research for bovine and porcine viruses
- Detection and quantification of impurities coming from the manufacturing process
- Quantification residual DNA /residual Host cell protein
- Detection of endotoxins
- Genetic characterization of recombinant cell lines
Cell therapy products
Gene therapy products
Tissue engineered products
Anticillary therapeutic reagents
Our services are designed for all following players in the biotechnology field:
Human Biopharmaceutical industry
Veterinary Biopharmaceutical industry
Contract research organizations (CRO)
Contract manufacturing organizations (CMO)
Manufacturers of biopharmaceutical cell culture products
Validation of tests
All our characterisation and biosafety tests for cell banks and intermediate/ final products are validated and are in compliance with the worldwide regulatory agencies. The protocols and validation reports are totally accessible during an audit or technical visit.
Our laboratories and teams
Clean Cells offer cGMP fully equipped BSL2 and BSL3 with qualified equipment. 80% of our team have a Master or PhD level of Higher education and regularly follow internal training programmes to maintain their expertise.
The cell and virus controls necessary to carry out viral safety testing are produced by Clean Cells in laboratories dedicated to generate Master or Working Cell or Virus Bank.
Our equipment are monitored 24hrs/24 and 7/7.
Regulatory support/Scientific support
The expertise of our regulatory affairs department and scientific support team insure that all your proposals and studies, are in compliance with the latest regulatory requirements that are worldwide imposed.
We will assist you in the completion of a safety dossier to be presented to the regulatory agencies.
More than a thousand cell banks/Bulk/final products characterised and secured by Clean Cells.
Large range of cell (CHO, HEK293, PERC6, MRC5, Murine hybridoma, VERO, Avian cells, Sf9…) and viral banks (Adenovirus, Retrovirus, AAV, ALV, Phages…) tested .