Our services for monoclonal antibodies
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 through an extensive portfolio of quality control assays. Our services cover the full characterization of cell lines and the required quality control at each step of biomanufacturing, up until the final product.
Our team has also developed innovative potency assays allowing for a simplified evaluation of the cytotoxicity of your pharmaceutical substances, including monoclonal antibodies.
Clean Cells holds a « Good Manufacturing Pratice » (GMP) licence and our quality control assays are duly validated against applicable guidelines.
Our laboratories are set in BSL-2 and BSL-3 environments and accommodate a large array of methods for biological products and intermediaries:
- Biosafety testing
- 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, endotoxins assay
- 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.
A portfolio of more than 200 qPCR assays allows for a fast and sensitive detection or quantification of a large number of micro-organisms.
Clean Cells performs cell banking activities to produce Master Cell Banks and Working Cell Banks (MCB, WCB) in a GMP environment. The banks may be further used as substrates for the generation of recombinant products, including monoclonal antibodies.
Our company has considerable experience manufacturing cell banks using a wide variety of cell lines and has collaborated with numerous stakeholders involved in mAb-based projects at clinical stages.
R&D banks may also be produced in non-GMP environments according to your specifications.