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

About the speaker

Ruth Kläver, PhD, Senior Global Product Manager

QIAGEN

Ruth Kläver has 10+ years of experience in different biotech- and pharma companies, holding various roles in product development, product management and operations. In her current role at QIAGEN, she manages product portfolios in Pyrosequencing and dPCR.

Miroslav Vranes, PhD, Associate Director R&D, dPCR Applications Development

QIAGEN

Miroslav Vranes studied biology at the Philipps University in Marburg. He completed his doctoral thesis at the Max Planck Institute for Terrestrial Microbiology in Marburg. After his postdoctoral research at the Karlsruhe Institute of Technology, he joined QIAGEN in 2015. Since then, he has been involved in developing products mainly for human identification and forensic applications.

David Dobnik, PhD, Co-founder and Chief Scientific Officer

Niba Labs

Since 2016, David Dobnik has been closely working with companies in the field of gene therapy (such as AveXis [now Novartis Gene Therapies]) to develop and apply methods for precise quantification of viral vectors (for example, dPCR), observation of viral particles (electron microscopy), and identification and quantification of impurities (for example, nucleic acids by high-throughput sequencing [HTS/NGS] or PCR-based methods). David has been leading the development and tech-transfer projects for pharmaceutical companies focused on gene therapy, helping their process development efforts with characterizations of viral vectors. Lately, most of his work has focused on new genome integrity evaluation approaches.