Quality Control TestingBiosafety Testing

A 20+ year expertise in biosafety testing

Clean Cells, a Contract Research Organization (CRO) and GMP-licensed company, has developed a considerable expertise in the biosafety testing of all types of biological products (vaccines, monoclonal antibodies, cell, gene and phage therapy) at all stages of manufacturing. This activity that has been at the core of our company since its creation in 2000, as part of our quality control department. Our license covers the testing of investigational (IND/IMP) and approved medicinal products and we also provide non-GMP assays for the testing of substances at the R&D stage.

Our biosafety assays are based on cell culture, and molecular and immune-enzymatic methods (qPCR, ELISA).

Our service offer includes :

Sterility (classical method or rapid testing via BACT/ALERT) and bioburden testing

Mycoplasma detection via direct culture, indirect culture, or qPCR

Detection of specific contaminants* (virus, bacteria, fungus) via qPCR and RT-qPCR

Retrovirus detection via infectivity and/or QPERT assay

Virus detection via Transmission Electron Microscopy (TEM)

Replication competent virus detection (RCL, rcAAV)

In vitro detection of extraneous agents via culture and qPCR

Mycobacteria detection via culture or qPCR

In vivo testing (adventitious viruses and tumorigenicity)

* Our expertise in the detection of microbiological contaminants is supported by the large number of qPCR-based assays developed over the years for the human and animal health industries.

Please reach out to the team for additional information or to discuss bespoke assay development.

 

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