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.
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.
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).