News & Events
Save the date ! New webinaire on January 14, 2021
Solutions for gene therapy products GMP biosafety testing – Focus on lentiviral vectors
Join Dr Xavier Leclerc on 14 JAN 2020 with our newest addition to our webinar series addressing matters of GMP biosafety testing of gene therapy products!
These innovative therapies, part of Advanced Therapy Medicinal Products (ATMP), are now widely used in a clinical context for a variety of genetic disorders and pose unique challenges when considering QC aspects.
Our webinar will tackle the subject of recombinant lentiviral vectors (rLv) which needs to be extensively characterized with respect to potency and safety prior to release and use in humans. For this purpose, QC assays must be performed according to the current regulatory framework in a GMP-licensed facility. Among these tests, some are specific to rLv batches and rLv-derived products and a scientific and regulatory expertise is required to develop, validate and routinely perform them according to regulatory guidelines and recommendations.
In this presentation, we will show 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.
Our expert :
Xavier Leclerc holds a PhD in Genetics and has more than 10 years of experience in the field of gene therapies and viral vector characterization. He joined Clean Cells in 2015 where he heads the development and validation activities related to gene therapy and serves as gene therapy specialist.
See you Thursday 14th January 2021 at 4:00 pm for this webinar.
Do not miss this event !
To register, it’s simple, just follow the link → https://bit.ly/2KtbqNG