Our phage therapy services
Clean Cells has long been involved in the development of phage therapy as a Contract Development and Manufacturing Organization and GMP-compliant quality control service provider.
Our early engagement in the first European trial has built an unparalleled expertise in pharmaceutical bacteriophages. We make this know-how and BSL-2 and BSL-3 graded laboratories available to sponsors with phage projects at all stages of development.
Clean Cells offers full process development services (upstream and downstream) to manufacture phage-based products. The process may be fully developed (“de novo”) or optimized from an existing process to reach compliance with Good Manufacturing Practices (GMP) and/or scaled up to reach industrial scales. The ready-to-use GMP processes may be transferred to sponsors or used in-house.
Process development relies on Quality by Design (QbD) approaches and on a Design of Experiment (DoE) software allowing for optimal yields, purity, and quality.
Our expertise in upstream processes draws on our team’s experience with numerous microbial strains and phage families and on equipments enabling microbial culture in aerobic and anaerobic conditions, from a few milliliters to a few liters, in flasks and fermenters.
Our knowledge of downstream processes relies on equipment allowing for purification operations, from small scale to 10L scale, including TFF systems (KrosFlo®KR2i, Repligen), filtration systems and chromatography systems (ÄKTA™ pure, Cytiva).
Banking and pre-clinical lot manufacturing
Our GMP environment, under strict environmental control, accommodates banking activities for the manufacture of therapeutic bacteriophages.
This manufacturing capacity includes the generation of microbial cell banks and phage banks used as biological starting material to produce clinical lots. Our precise knowledge of phages and phage substrates, our quality control expertise, and our validated cleaning procedures enable the production of safe and potent starting material.
Clean Cells’ variety of equipment, analytical capacities and bioprocess experience are employed to support our pre-clinical lot manufacturing activity and help us achieve high levels of purity, quality and safety through advanced flexibility.
Quality control and analytical development
Clean Cells is a leader in biopharma quality control and benefits from more than 20 years of experience handling various medicinal products, from vaccines to gene therapy products.
Our Good Manufacturing Practices certificate supports an extensive portfolio of assays to fully test biological substances, including bacteriophages, from starting material to clinical and commercial lots.
Our company also specializes in the development of analytical methods intended for product characterization and process evaluation, according to physico-chemical, biosafety, purity, identity, and potency criteria.
These bespoke methods may go through validation according to international guidelines (in particular, ICH Q2R1) to be used in a GMP context and transferred to sponsors or integrated into an inhouse production project.