Lentiviral and gammaretroviral vectors are the most popular retroviral vectors used in gene and cell therapies with more than 300 clinical trials currently underway in Phase II and Phase III. Quantifying quality attributes of these retroviral vectors is of increasing importance as they enter into the late development stages. In this webinar we demonstrate the use of two analytical techniques, batch dynamic light scattering (DLS) for rapid, low-resolution measurements and multi-angle light scattering in combination with field-flow fractionation (FFF-MALS) for extended characterization of viral vectors. We will discuss methods for evaluation of the size distribution and physical titer, impurity profiling, in-depth assessment of aggregation, and lot-to-lot variability.
Key Learning Objectives:
- How DLS and MALS determine particle size and concentration
- How high-throughput DLS rapidly screens processes and formulations for titer, purity, aggregation and stability
- How FFF-MALS is used to compare different viral vector lots and purification protocols, assess stability and quantify impurities
- How DLS and FFF-MALS can be used in viral vector production and lot release assays
Who Should Attend:
- Scientists and managers, working in the gene and cell therapy field, in need of robust, reliable, simple, and fast methods to characterize and quantify viral vectors.
- CMC regulatory specialists seeking to identify validatable analytical tools that are orthogonal and complementary to current CQA quantification methods.
- Managers of academic labs and core facilities developing viruses and non-viral nanoparticles, that need straightforward biophysical methods to quantify gene vectors.