For several years, Cleans Cells has been participating in the development of the use of bacteriophages through its integrated CRMO activities. Our services cover the manufacture and characterization of bacteriophages, either therapeutic ones and destined to the human and veterinary industries or for agri-food and cosmetic purposes.
These services, including the manufacture of clinical grade lots, are covered by our various GMP licenses.
It is through the Phagoburn consortium (a unique clinical experience for phage therapy in Europe) that Clean Cells developed an expertise in the manufacture of phage-based substances and designed relevant QC testing strategies to ensure their potency and safety.
Clean Cells is able to perform the GMP-compliant manufacture of the microbial and phage banks and the generation of clinical material up until the final lot. Non-GMP banks can also be produced and assessed for their potency.
Our laboratories are set in BSL-2 and BSL-3 environments, allowing us to perform a large array of methods for these specific substances and their intermediaries:
- Titration (microbial and phage banks)
- Host range determination (bacteriophages)
- Purity and sterility testing
- Prophage detection and amplification potency (microbial banks)
- Development of qPCR assays for the specific detection of phages in cocktails
- Genetic characterization of strains (RAPD-PCR testing, 16S DNA sequencing, full sequencing)
- Impurities or residues quantification: HCP, residual DNA, BSA/Benzonase
- Bacterial endotoxins assay
- Range of physic-chemical assays for drug substances and products: total proteins, protein profile, visual aspect, pH, integrity of containers.
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.