Development Of A CGMP-Validated Replication Competent Lentivirus (RCL) Assay For Release Testing Of Manufactured Viruses And Gene Mediated Cell Therapy Products

Lentiviruses are widely utilized in cell and gene therapies due to their exceptional ability to efficiently deliver genetic material into both dividing and non-dividing cells, making them ideal for a broad range of therapeutic applications. Their versatility is evident in their use for treating genetic disorders, engineering immune cells, and modifying stem cells—applications that have undeniably revolutionized modern medicine. Recombinant lentiviral vectors, derived from the HIV-1 virus, are engineered to be replication-deficient to enhance safety.
However, the risk of recombination events during vector production, which could generate replication-competent lentiviruses (RCLs), remains a critical safety concern. Even trace amounts of RCLs can pose significant risks to patient safety, potentially manifesting as unintended viral replication or pathogenic effects. Addressing the risks associated with RCLs is essential to ensure the safe and effective application of lentiviral vectors in advanced therapeutic interventions.
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