Clean Cells' Webinar - Solutions for gene therapy products GMP biosafety testing
Solutions for gene therapy products GMP biosafety testing - Focus on lentiviral vectors
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Animated by Xavier LECLERC & Aymeric HUGUENOT.
Thursday 14th January 2021 at 4:00 pm.
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Description :
Recombinant lentiviral vectors (rLv) used as gene therapy products are now involved in clinic and in clinical trials for a variety of inherited and acquired disorders. Before to be used in humans, rLv vectors and rLv-derived products batches must be characterized with respect to their potency and safety for release. For this, QC tests aiming at characterizing their potency profile and demonstrating their safety must be performed according to the regulatory framework in force in a GMP-certified facility. Among these tests, some are specific to rLv batches and rLv-derived products and they require a scientific and regulatory expertise to be developed, validated and routinely performed according to the regulatory guidelines and recommendations. In this presentation, we will exhibit how Clean Cells provides ready-to-use and customized QC solutions along with a regulatory expertise for lentiviral gene therapy stakeholders using well-established techniques and anticipating the integration of breakthrough technologies of interest (dPCR, NGS …). We will browse the different QC tests available at Clean Cells with a focus on the specific tests for rLv products and derived products characterization and on the detection of replicative-competent lentiviral particles (RCL) which one remains challenging with regards to the representativeness of the tested samples.