Lentiviral titer determination: Rapid and robust molecular methods suitable for validation
Sponsor
High quality recombinant lentiviral vectors are key for transgene delivery in many cell and gene therapies, including several of the FDA-approved chimeric antigen receptor (CAR) T-cell products. Critical to the success of these biologics are reliable methods to characterize and quantitate lentiviral vectors as the drug substance. Quantitation of total genome-containing particles and infectious particles is valuable to optimize the vector production process and to appropriately dose for cell transduction at the desired MOI. Vector copy number is also a critical quality attribute to assess integration and safety of transduced cell products.
In this webinar, an overview of quality attributes, regulatory expectations, and challenges in lentiviral vector titer and characterization will be discussed. Two qPCR assays that enable quantitation and correlation of total and infectious lentivirus particles will be presented. These assays have been designed to facilitate lentiviral vector analytics in process development and manufacturing QC.
Attendees will receive:
- An overview of key considerations in lentiviral vector quantitation
- Discussion of current challenges and limitations Introduction to two qPCR-based assays that provide a rapid, robust, and QC-amenable solution for lentiviral vector characterization
- Review of assay performance data to enable validation per industry expectations
