Since its creation, Cleans Cells has been committed to ensuring the safety and quality of products based on DNA recombination (monoclonal antibodies, recombinant proteins, etc.) and of the associated processes. Our services cover the full characterization of cell lines and the required quality control at each step of biomanufacturing, up until the final product.
Furthermore, our team has developed innovative potency assays allowing for a simplified evaluation of the cytotoxicity of your pharmaceutical substances, notably monoclonal antibodies.
2- Quality Control
Our laboratories are set in BSL-2 and BSL-3 environments, allowing us to perform a large array of methods for biological products and their intermediaries :
- Sterility testing according to 2.6.1 or 2.6.27 (BacT/ALERT automated system)
- Mycoplasma detection via culture, epifluorescence or qPCR
- Virus and adventitious contaminants detection (in vitro, in vivo, TEM) including bovine/porcine contaminants detection and retrovirus detection (PERT)
- Identity testing (cell line authentication), genetic characterization (GCN, VCN) and cytogenetics tools (karyotype studies, G-banding, FISH, etc.)
- Impurities or residues quantification: HCP, residual DNA, BSA/Benzonase
- Bacterial endotoxins assay
A portfolio of more than 200 qPCRs allows a fast and sensitive detection or quantification of a large number of micro-organisms.
Viral Clearance :
Custom-made viral clearance services can be proposed upon request to ensure the efficacy of your removal and inactivation steps.
Cytotoxicity potency assays (ADCC, CDC, etc.)
The team at Clean Cells has developed and validated a luminescence-based method showing a comparable sensitivity to typical Cr51-based techniques, thus allowing for a simplification of cytotoxicity potency assays for diverse biological products (antibodies, CAR-T cells, etc.).
A transduced effector cell line has also been engineered specifically for ADCC studies, substantially reducing the variability induced by the use of NK cells or PBMCs.
Clean Cells is a CRMO with GLP & GMP certifications issued by the competent regulatory authorities. Our assays comply with global regulatory guidelines, notably issued by the EMA, FDA, ICH and WHO.