Vaccines
Since its creation, Cleans Cells has been committed to ensuring the safety and quality of both human and veterinary vaccines. 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 extensive collaboration with major companies of the field halped us develop a large portfolio of assays along with the regulatory compliance and expertise required for the design of relevant characterization strategies based on the specificities of your project.
Capacities
1- Manufacturing
Clean Cells is able to perform the GMP-compliant manufacture of the cell and viral banks (MCB, WCB, MVSS, WVSS) used for the generation of vaccines as well as the manufacture of non-GMP Research Banks.
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
- Tumorigenicity
A portfolio of more than 200 qPCRs allows a fast and sensitive detection or quantification of a large number of micro-organisms from various species.
Compliance
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.