Clean Cells was founded in 2000 in Montaigu-Vendée, France, by three scientists following recognition by the Aventis–Institut de France Foundation. The company’s founding purpose was to provide a specialist range of biosafety testing services for biopharmaceuticals at a time of growing regulatory demand for rigorous biological product safety assessment. ISO 9001 certification was obtained in 2002, and a GLP licence was awarded by the French regulatory authority (ANSM) in 2004 following its first regulatory inspection. A pharmaceutical establishment certification was obtained in 2014, enabling the company to expand into manufacturing operations.

Clean Cells is headquartered at 4 Rue Nicolas Sadi Carnot, ZA le Point du Jour, Montaigu-Vendée (85600), France. In 2018, Clean Cells joined the Clean Biologics group, an entity founded by the original Clean Cells co-founders and backed by ArchiMed, the Lyon-based healthcare-specialist private equity firm. The group also encompasses Naobios, a Nantes-based CDMO specialising in GMP-grade virus-based product manufacturing up to clinical Phase III. In January 2023, Clean Cells opened a new purpose-built facility that quadrupled its analytical and production capacities. The company is led by CEO Laurent Claisse, appointed to accelerate US and global market expansion.

Clean Cells’ active M&A programme has extended its capabilities significantly in recent years, with the acquisitions of Karyologic (US biologics market expansion and karyotyping), Stem Genomics (cell therapy quality control and US presence), and Anaquant (analytical capabilities in biomanufacturing quality control). The company serves clients globally across Europe, the United States, and Asia, encompassing pharmaceutical companies, biotechnology organisations, and ATMP developers at all stages of development.

Key Products and Services

Biologics Biomanufacturing

• Clonal selection — isolation and characterisation of clonal cell populations for biologics production programmes, including monoclonal antibody and recombinant protein manufacturing
• Cell banking — GMP-grade Master Cell Bank (MCB) and Working Cell Bank (WCB) production and characterisation for mammalian, insect, and microbial cell systems
• Virus banking manufacturing — GMP-grade Master Virus Bank (MVB) and Working Virus Bank (WVB) production and characterisation for viral vector, viral vaccine, and oncolytic virus programmes

Biologics Testing

Biosafety Testing

• Microbiology testing — sterility testing, mycoplasma detection (including nucleic acid testing and culture methods), bacteriostasis and fungistasis, endotoxin testing, and environmental monitoring
• Viral safety testing — in vitro and in vivo adventitious agent testing, specific virus detection, replication competent lentivirus (RCL) and replication competent retrovirus (RCR) testing, and virus clearance validation

Product Characterisation

• Impurity testing — host cell protein (HCP) quantification, host cell DNA detection, residual reagent testing, and process-related impurity analysis
• Potency testing — cell-based and biochemical potency assays for biopharmaceuticals and ATMPs, including phase-appropriate potency strategy development
• Biologics identity testing — identity confirmation via biochemical and molecular methods for biopharmaceuticals and cell and gene therapy products

Additional Testing Services

• Raw material testing — biological, chemical, and microbiological testing of raw materials and ancillary materials used in biopharmaceutical manufacturing
• Cell bank testing — comprehensive characterisation testing of cell banks to ICH Q5D and regulatory authority requirements
• Virus bank testing — characterisation and safety testing of virus banks to regulatory standards for viral vector and vaccine programmes
• Lot release testing — GMP-compliant lot release testing for biopharmaceutical products prior to clinical or commercial use

Analytical Development

• Development, optimisation, and qualification of analytical methods for biologics testing, including novel assay development for emerging modalities such as ATMPs and exosomes

Biologics Storage

• Cell bank storage — GMP-compliant cryogenic storage of cell banks with multi-redundant temperature monitoring and full chain-of-custody management
• Virus bank storage — GMP-compliant cryogenic storage of virus banks under equivalent monitoring and security conditions

Product Type Coverage

Vaccines (human and veterinary), recombinant proteins and monoclonal antibodies, viral vectors (lentiviral, AAV, adenoviral), gene therapy products, cell therapies (CAR-T and other ATMPs), oncolytic viruses, veterinary biological products, cell-based food, raw and ancillary materials, and exosomes.

Clean Cells occupies a well-defined specialist position within the European biologics contract services sector, with particular depth in biosafety testing — the foundational regulatory discipline that underpins product release and regulatory submission for all biological medicinal products. Its 25 years of GLP- and GMP-compliant testing operations, French regulatory authority accreditation, and the breadth of its product type coverage — spanning conventional biologics, viral vectors, ATMPs, and emerging modalities — position it as a credible and experienced testing partner for both established biopharmaceutical manufacturers and emerging cell and gene therapy developers. Membership of the Clean Biologics group, backed by ArchiMed, provides access to capital and strategic direction that has enabled an accelerating acquisition strategy, with Karyologic, Stem Genomics, and Anaquant each adding distinct analytical capabilities and geographic reach, particularly in the United States. The 2023 facility expansion, which quadrupled capacity, signals readiness for increased commercial volume at a time when demand for biologics testing and ATMP quality control services continues to grow.