Phage Therapy

PHAGE THERAPY

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.

CAPACITES

Manufacturing

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.

Quality Control

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.

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.

 

Our News & Events

  • BE Vaccines is now NAOBIOS

    After joining Clean Cells on March 1st, 2019, BE Vaccines has been renamed NAOBIOS.

  • Press Release

    On March 1st, 2019, Clean Cells acquired BE Vaccines, a French subsidiary of the Indian Pharmaceutical Company…

  • Clean Cells’ Events

    In the first quarter, join the Clean Cells’ team at: PHAGE FUTURES CONGRESS, CarT CONGRESS EU, BACTERIOPHAGE THERAPY SUMMIT…

  • Clean Cells accelerates its developments

    Clean Cells opened its capital to ArchiMed to support its growth strategy in the biopharmaceutical sector

  • Clean Cells’ Events

    In the fourth quarter,
    join the Clean Cells’ team at BioJapan, ESGCT, BioEurope…

  • Clean Cells’ Events

    Meet with Clean Cells. In the second quarter, join the Clean Cells’ team at: VIRAL SAFETY FOR BIOLOGICS, BIOMED…

  • Clean Cells’ Events

    In the first quarter,
    join the Clean Cells’ team at:
    CELL & GENE THERAPY WORLD

  • New collaborative project “HybridADCC”

    Capitalising on the success of Premium ADCC, Clean Cells will provide its skills in cell culture and in the development of…

  • ACTIP MEETING

    Thursday 30 Nov, in Nantes, the ACTIP (Animal Cell Technology Industrial Platform) organized a meeting for its members.

  • Boost Your Brain

    “Boost your Brain” aim at providing information to our personnel about diverse topics concerning the biopharmaceutical field…

  • Clean Cells’ Events

    In the third quarter, join the Clean Cells’ team at : Regmed Europe and NLSDays

  • Clean Cells’ Events

    Meet with Clean Cells. In the first quarter, join the Clean Cells’ team at the Centennial Celebration of Bacteiophage research…

  • Clean Cells’ Events

    Meet with Clean Cells. In the first quarter, join the Clean Cells’ team at :
    BIOTECH SHOWCASE 2017…

  • Clean Cells’ Events

    Meet with Clean Cells. In the fourth quarter, join the Clean Cells’ team at :
    WORLD VACCINE CONGRESS…

  • Clean Cells’ Events

    In the third quarter, join the Clean Cells’ team at : ANTIBODY INDUSTRIAL SYMPOSIUM, EMBO CONFERENCE, BIOREGATE FORUM…