Gene Therapy

GENE THERAPY

Cleans Cells has very early been committed to the development of Advanced Therapy Medicinal Products (ATMPs) and highly involved in gene therapy as a CRO. Our services cover the manufacture of substrates used for vector generation and the characterization of the starting material and products of the different steps of production, up until the final product but also for clinical monitoring purposes.

Our extensive collaboration with major companies of the field helped us develop a large portfolio of assays along with the regulatory compliance and expertise required for the design of relevant characterization strategies based on the specificities of your project.

CAPACITES

Manufacturing

Clean Cells is able to perform the GMP-compliant manufacture of the mammalian, insect and microbial cell & virus banks used as substrates for the generation of plasmids and viral vectors as well as non-GMP Research Cell Banks for yield optimization (cloning and banking).

Quality Control

Our laboratories and specific equipments allow us to perform a large array of methods for in vivo and ex-vivo gene therapy products and their intermediaries:

  • 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, viral sequences or genetic elements of interests (plasmids)
  • Bacterial endotoxins assay
  • Replication competent virus testing (RCL, RCAAV)
  • Physical or infectious vector titre determination
  • Cytotoxicity (potency) read-out method for CAR-T projects

Some of these methods such as RCL and VCN testing may also be applied for clinical monitoring purposes (shedding studies).

 

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…