Recombinant Proteins

RECOMBINANT PROTEINS

Since its creation, Cleans Cells has been committed to ensuring the safety and quality of products based on DNA recombination (monoclonal antibodies, recombinant proteins, etc.) and of the associated processes. Our services cover the full characterization of cell lines and the required quality control at each step of biomanufacturing, up until the final product.

Furthermore, our team has developed innovative potency assays allowing for a simplified evaluation of the cytotoxicity of your pharmaceutical substances, notably monoclonal antibodies.

CAPACITES

Manufacturing

Clean Cells is able to perform the GMP-compliant manufacture of the cell banks (MCB, WCB) used as substrates for the generation of recombinant products as well as non-GMP Research Cell Banks.

Quality Control

Our laboratories are set in BSL-2 and BSL-3 environments, allowing us to perform a large array of methods for biological 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
  • Bacterial endotoxins assay
  • Tumorigenicity

A portfolio of more than 200 qPCRs allows a fast and sensitive detection or quantification of a large number of micro-organisms.

Viral Clearance :

Custom-made viral clearance services can be proposed upon request to ensure the efficacy of your removal and inactivation steps.

Cytotoxicity potency assays (ADCC, CDC, etc.)

The team at Clean Cells has developed and validated a luminescence-based method showing a comparable sensitivity to typical Cr51-based techniques, thus allowing for a simplification of cytotoxicity potency assays for diverse biological products (antibodies, CAR-T cells, etc.).

A transduced effector cell line has also been engineered specifically for ADCC studies, substantially reducing the variability induced by the use of NK cells or PBMCs.

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…