On Tuesday, October 1, 2019, Wyatt Technology welcomed customers from a variety of prominent gene therapy companies to participate in a special workshop at the company’s headquarters in Santa Barbara, CA. Although the meeting was announced only to a small number of recent Light Scattering University graduates a few weeks before, participants from all over the United States convened to discuss adeno-associated viruses (AAVs) and the ways in which the use of multi-angle light scattering can determine critical quality attributes (CQAs) in development and production processes for clinical applications. While all of the companies participating already use Wyatt’s DAWN—and some with DynaPro Plate Reader technologies as well—the workshop enabled a granular look at how specific aspects of ASTRA and DYNAMICS software could be used even more effectively.
Led by Wyatt Technology’s Analytical Services team, the interactive workshop included lectures, step-by-step tutorials, and multiple Q&A sessions. The event highlighted a powerful new method recently developed incorporating size-exclusion chromatography (SEC) combined with ultraviolet (UV), multi-angle light scattering (MALS) and differential refractive index (dRI) detection. As was demonstrated throughout the day, the SEC-UV-MALS-dRI method can readily quantify #1) the total viral particle concentration, #2) the ratio of empty to full capsids, and #3) the degree of aggregation. An alternative—and analogous—separation technique called field-flow fractionation (FFF) was also discussed. Because FFF has no stationary phase that can damage or perturb the samples, it is able to characterize large AAV aggregates and other gene delivery vehicles like lentiviral vectors, exosomes, and lipid nanoparticles in ways that SEC cannot. Automated dynamic light scattering (DLS) applications were also singled out that offer rapid high-throughput sizing, counting, and screening of this new class of therapeutic drugs: from early-stage research to product development and quality control.
The customer interactions throughout the day were invaluable, and will lead to more customized software and hardware solutions specifically tailored to these applications. Using Wyatt’s light scattering platforms has begun to enable implementing these important biophysical characterization methods during the manufacturing process and as release assays for the AAV mediated gene therapy products. More meetings of this type—to be held throughout the US—have already been scheduled.