An Orthogonal Approach for Comprehensive AAV Characterization

As the field of gene therapy progresses, processes to produce this life-changing therapy may introduce impurities that can significantly impact its performance and quality.

Join Dr. Ben Draper, analytical lead at MegaDalton Solutions and Dr. Dr. Sophia Kenrick, head of analytical services at Waters|Wyatt Technology, for a deep dive into tackling critical impurities, particularly empty AAV capsids. Discover how size exclusion chromatography with UV and multiangle light scattering (SEC-MALS) can be optimized to ensure accurate measurements.

They will also explore the full-to-empty ratio as well as the quantification of partials using charge detection mass spectrometry (CDMS). Find out how SEC-MALS and CDMS can revolutionize analytical development and quality control testing. Plus, learn how the standard AAV Method Implementation and Training Service, as well as SOP Guidance Manual, can facilitate the adoption of advanced technology as a platform method for AAV development and production.

Key learning objectives

• Understand the application of multi-angle light scattering coupled to size exclusion chromatography (SEC-MALS) for determining:

  • Molar mass
  • Aggregation
  • Empty/Full analysis
  • Titer of the capsid and genome

• Gain insights into the use of charge detection mass spectrometry for analyzing partial capsids

• Explore the advantages of employing orthogonal techniques for ccomprehensive AAV characterization

Presenter: Dr. Ben Draper (Analytical Lead, MegaDalton Solutions)

Dr. Ben Draper holds a PhD from Indiana University. During his doctoral research, he optimized charge detection mass spectrometry (CDMS) data handling, enhancing detection sensitivity. As the Analytical Lead at MegaDalton, he collaborates extensively with pharmaceutical companies, specializing in characterizing large, complex therapies like AAVs, adenovirus, and virus-like particles. He continues to address the needs of scientists for accurate reporting of absolute masses of products for confident identification and safety of their therapeutics products.

Presenter: Dr. Sophia Kenrick (Director of Analytical Sciences, Waters | Wyatt Technology)

Dr. Sophia Kenrick has a PhD in Chemical Engineering from the University of California. As head of the Analytical Sciences team at Waters|Wyatt Technology, she supports emerging light scattering instrumentation applications. She also develops new solutions to address customer applications, including the development of platform SEC/FFF-MALS methods for multi-attribute quantitation (MAQ) of gene therapy products, biopharmaceuticals, and other macromolecules.

Presenter: Sofia Hamadache (SelectScience)

Sofia studied Chemistry at University College London, UK. As a member of the Editorial team, she now plays an integral role in shaping the content on SelectScience.