Biosafety Testing

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 .

Our expertises

Characterisation, safety of cell banks (eukaryotic & prokaryotic)
Biological safety of virus banks
Viral safety of intermediary products
Safety of the final product (batch release)

Our methods

  • 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

Your products

Therapeutic antibodies
Recombinant proteins
Vaccines
Cytokines
Therapeutic adjuvants
Cell therapy products
Gene therapy products
Tissue engineered products
Blood products
Anticillary therapeutic reagents

Our customers

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)
Research institutes
Cosmetics industry
Manufacturers of biopharmaceutical cell culture products

Our differences

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.

Our experience

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 .

 

Catalogue Test

Our News & Events

  • Clean Cells’ Events

    Meet with Clean Cells. In the first quarter, join the Clean Cells’ team at the Centennial Celebration of Bacteiophage research…

  • Clean Cells’ Events

    Meet with Clean Cells. In the first quarter, join the Clean Cells’ team at :
    BIOTECH SHOWCASE 2017…

  • Clean Cells’ Events

    Meet with Clean Cells. In the fourth quarter, join the Clean Cells’ team at :
    WORLD VACCINE CONGRESS…

  • Clean Cells’ Events

    In the third quarter, join the Clean Cells’ team at : ANTIBODY INDUSTRIAL SYMPOSIUM, EMBO CONFERENCE, BIOREGATE FORUM…

  • Clean Cells’ Newsletter

    Clean Cells is doing every to propose solutions that allow them to follow daily its activities. This is the reason why…

  • Of phages and men

    Clean Cells, as an authorized pharmaceutical facility, is now in position to offer its customers a wide panel of services for drug…

  • Clean Cells Tunes into Gene Therapy

    Clean Cells expands its service portfolio by tuning into gene therapy products since the beginning of 2015…

  • Clean Cells joins Come In Vendée

    Artists, merchants and companies from the Vendée that will unit to participate to the next Vendée Globe?…

  • Clean Cells’ Events

    In the second quarter, join the Clean Cells’ team at

  • Phage Therapy

    The Lancet ID published in november, 2015, a publication about PhagoBurn project, called “Phage therapy for severe infections…

  • ESGCT, Helsinki – Finland

    Dr Arnold Van der Luit will be attending the ESGCT (European Society of Gene and Cell Therapy), in Helsinki, Finland…

  • Workshop bacteriophages

    On 8 June 2015, the European Medicines Agency organized a workshop on the therapeutic use of bacteriophages…

  • Clean Cells’ New Office

    We are thus pleased to announce that we are setting up an new office in London, UK…

  • ESACT, Barcelona – Spain

    The Clean Cells team will be present at ESACT at booth 54. Visit us and learn more about our solutions for Biosafety Testing…

  • PEGS, boston MA – USA

    Clean Cells introduces a new bioassay to measure antibody specific effects. Join the presentation given by Dr. Rossignol…