Clean Cells is a GMP-licensed Contract Development and Manufacturing Organization providing Research & Development, production, and quality control testing services to the biopharmaceutical industry. The company’s two-part site holds an innovative process development platform, BSL2, and BSL3 GMP manufacturing laboratories, and analytical areas to develop bespoke assays and perform GMP testing. Clean Cells is part of the Clean Biologics group and benefits from the additional experience of sister company Naobios, a CDMO with considerable experience in the development and manufacture of virus-based products.
The following is a list of the broad spectrum of services offered by Clean Cells:
- Manufacturing – 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.
- Quality control – laboratories are set in BSL-2 and BSL-3 environments, allowing the company 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, the integrity of containers
- Compliance – Clean Cells is a CRMO with GLP & GMP certifications issued by the competent regulatory authorities.