Our services for vaccines
GMP-compliant quality control
Our company is committed to support stakeholders of the vaccine industry thanks to a full panel of quality control assays for the evaluation of biomedicines and bioprocesses, including vaccines for human and animal health. Our tests ensure the highest safety at various stages of manufacturing, from starting material, through cell and virus banks, to clinical and commercial lots.
Our collaboration with major actors of the industry has helped us create a varied service offer while achieving regulatory compliance and expertise need to build relevant quality control testing strategies.
Our tests and assays for quality control are validated against international guidelines and are supported by a « Good Manufacturing Practice » (GMP) licence issued by the ANSM (Agence Nationale de Sécurité du Médicament – french national regulatory agency).
Our facility consists of BSL-2 and BSL-3 laboratories for the testing of various substances and intermediaries of biological origin:
- 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
A large number of contaminants may be detected and quantified thanks to our portfolio of more than 200 qPCR-based assays (list available upon request).
All our assays can be offered in R&D grade (non-GMP).
Cell and virus banking
Clean Cells’ GMP environment accommodates the production of cell banks and virus seed stocks further used for the manufacture of vaccines. Our technical expertise is built from handling hundreds of cell and virus types and allows for the generation of highly safe and potent Master and Working banks and seed stocks.
Our experience is supported by numerous collaborations with partners worldwide involved in the manufacture of various biological pharmaceuticals.
Clean Cells can also address non-GMP cell and virus banking needs to generate substrates used at R&D stages.