Activity areaGene and cell therapy

Quality control testing of cell and gene therapy products : an expertise born from a technological challenge

Cell and gene therapy products, part of the Advanced Therapy Medicinal Products (ATMPs), are a breakthrough in modern medicine. When considering the quality control testing of these cutting-edge medicines, specific scientific know-how and equipment are required.

Clean Biologics benefits from the expertise of GMP-certified company Clean Cells which provides innovative analytical tools dedicated to the quality control testing of cell and gene therapies.

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Innovative assays for the quality control testing of advanced therapies

Clean Cells’ panel of assays includes tests used for the characterization of traditional biologics but also includes specific methods for:

  • The testing of cell-based therapy products: fast turnaround tools (BACT/ALERT for sterility and numerous qPCR assays) for the detection of contaminants and cytogenetics methods for the performance of G-banding karyoping and studies using FISH (Fluorescence In Situ Hybridization).
  • The testing of gene therapy products: replication competent lentivirus and AAV tests, respectively RCL and RCAAV assays, qPCR detection of plasmidic genetic sequences and other sequences of interest or cytoxicity evaluation of CAR-T cells (Chimeric Antigen Receptor T cells) using an innovative luminescence-based assay.

Please feel free to reach out to our team to get a full list of our assays for the testing of advanced therapies.

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A team highly trained to the quality control testing of cell & gene therapies

Our R&D and QC teams have gathered substantial knowledge with experience in the academia and in the industry through the development and the performance of assays a large number of cell therapy products, based on human Embryonic Stem Cells (hESC), Mesenchymal Stem Cells (MSC) or induced Pluripotent Stem Cells (iPSC); they are also experienced in the testing of numerous gene therapy products, whether being viral vectors or CAR-T cells (autologous or allogenic).