Streamlined dPCR Workflow For Lentiviral Characterization And QC Of Cell & Gene Therapies

Lentiviral vectors (LVVs), a robust technology for delivering therapeutic genes into cells, and accurate LVV characterization are crucial to help ensure the safety, efficacy and consistency of cell and gene therapies (CGT) for diseases such as cancer, genetic disorders and rare inherited conditions.

Accurate assessment of viral genome titer and vector copy number (VCN) supports consistent product quality, optimal dosing and provides insights into transgene stability and expression. Additionally, testing for replication-competent lentivirus (RCL), an unintended byproduct of recombination, is a critical regulatory requirement mandated by the FDA and EMA to safeguard patient outcomes and ensure treatment integrity.

In this webinar, experts from QIAGEN and Niba Labs will present a streamlined dPCR-based workflow for quantifying lentiviral genome titers, VCN, and RCL. This enhanced workflow supports standardized, high-precision quality control (QC) and enables both singleplex and multiplex applications. David Dobnik from Niba Labs will also share his end-user perspective, providing first-hand insights into the lab’s experience using these kits in real-world CGT workflows.

A live Q&A session will follow the discussion, where you can engage directly with our panelists and get your questions answered.

Learning points:

• Why is accurate measurement of viral genome titers, VCN and RCL critical for safety, consistency and regulatory compliance in cell and gene therapy
• How digital PCR enables absolute quantification with high precision, accuracy and reproducibility, which are essential for manufacturing consistency and regulatory compliance
• The benefits of a streamlined, high-throughput workflow for standardized quality control in CGT manufacturing