Cell Therapy

Cell therapy has undergone significant development in recent years. It encompasses a broad number of products and strategies. 

Some diseases in humans are due to non functional cells or tissue. Cell therapy products, such as cells derived from Pluripotent Stem cells (iPSC) or human Embryonic Stem Cells (hESC), may be used to repair a defective function in patients. Using their pluripotency capabilities, these cells could be differentiated in vitro into functional cells. Treatments consist then to use its cellular product to replace non functional cells in patients.

Cell therapy is part of the immunotherapy field applicable to patients suffering from cancer. Cells from patients or donors can be collected generally from blood, purified, modified or stimulated ex vivo to gain or recover  their ability to enhance an immune anti-tumor response when they are injected (or re-injected) in patients.

Clean Cells, with its extensive regulatory expertise and GMP licence, is a trusted provider of cell therapy dedicated services. Clean Cells offers a wide range of services, including QC testing and characterization and storage solutions in secured spaces.

Clean Cells’ expertise in cell therapy services enables assisting their clients in advancing their products from preclinical development to clinical trials and ultimately to commercialization.

Biologics testing

Clean Cells is a market leader in biologics biosafety testing, with extensive experience in cGMP expertise and the development and validation of a variety of assays  for the entire range of cell therapy products. Depending if this is an autologous or an allogenic approach, Clean Cells provide the most suitable and relevant range of tests to ensure the safety of patients.

Our cell therapy dedicated catalogue has been implemented with specific assays for the evaluation and GMP testing of cell therapies, including phenotype analyses (undifferentiation and differentiation markers), karyotyping, potency assays and recombinant lentivirus (RCL) for CAR-T products. 

Clean Cells offers rapid testing options for lower test volumes and quick turnarounds and stays up-to-date with regulatory frameworks to establish customized cell therapy testing services required by the EMA and FDA.

Cell-Therapy-Testing
  • Full Characterization of vectors (incl. RCL testing) & starting material (HEK293T banks, EOPC, etc.)
  • Genetic characterization:
    • Karyotyping (G-Banding), FISH, dPCR, Sequencing (subcontracted)
  • Rapid testing modalities on drug product in addition to classical methods:
    • Sterility (BACT/ALERT® 3D), Mycoplasma (Biofire® and qPCR), Viral contaminants by qPCR
  • Novel potency assay: Bioluminescence-based evaluation of cytotoxicity
  • Customized assay development :
    • VCN, Flow cytometry, Cell-based, Biomolecular…
Cell-Therapy-CustomAnalyticalDev

Custom analytical development

Clean Cells has integrated an analytical development platform within cell therapy CDMO solutions to best accommodate specific needs and tailored solutions, including NGS, biomolecular methods (qPCR, dPCR), tests on cell lines, bio- and immunoassays. Our QC development team provides analytical consulting, de novo assay development and optimization/validation services in accordance with ICH Q2R1. 

They make up an integrated analytical development service for solutions closest to your product.

Storage

Cell therapy manufacturing must count on reliable and stable banks which is ensured by proper storage. 

Our integrated services provide bank storage to ensure the high level of security, safety, protection, and stability for starting material used in R&D and GMP bioprocesses. 

Our bank storage solutions rely on secured and restricted areas, 24/7 surveillance of parameters and continency programs in a brand-new building with the highest standards.

Leaflet

Flyer-CellGene_26022024

Leaflet

Cell & Gene Therapy Leaflet

Download via media library

Please let us know if you have any question on our cell therapy capacity and to discuss custom-made programs for your products.

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