Lentiviral vectors (LVs) are essential tools in cell and gene therapy, but their manufacturing demands rigorous analytical controls to help ensure safety and potency. In this webinar, Senior Scientists from SK pharmteco, Jae Hwang and Oxana M. Tsygankova, present an integrated platform solution that enhances yield and analytical rigor using digital PCR (dPCR) and ion exchange (IEX) membrane technology.
You'll learn how a cGMP-compliant assay framework, optimized purification steps and novel dPCR applications come together to support robust, high-quality LV production from development through commercial scale.
Key learnings
- How regulatory expectations for replication-competent lentivirus (RCL) testing are met using a dual-method approach (dPCR + p24 ELISA)
- Development and application of dPCR-based assays for quantifying LV genomic RNA and vector copy number (VCN)
- Optimization of IEX membrane purification, doubling infectious unit recovery while reducing processing time to under one hour