Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand for These Viral Vector Delivery Systems



19th October 2023 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Seth Levy, Director of Bioprocess Development at Modalis Therapeutics and Gael Nicolas, Senior Technical Sales Specialist at Refeyn |WATCH FOR FREE

Modalis’ epigenetic editors are designed to efficiently target genes and control chromatin conformation by coupling an engineered Cas9 variant with epigenetic effector domains, referred to as GNDM (Guide Nucleotide Directed Modulation), which is delivered via a single AAV vector. Most AAV capsids used for systemic treatments require high doses, leading to safety concerns. To overcome such obstacles, Modalis has evaluated numerous novel AAV capsids, allowing for reduced dosing, increased safety margins, and higher

Therapeutic efficacy. These novel capsids do not always play nicely with standard manufacturing techniques and available reagents, so creative process development and analytics are needed to bring these promising therapeutic molecules to patients

Presented by Seth Levy, Director of Bioprocess Development at Modalis Therapeutics

Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand For these Viral Vector Delivery Systems. Presented by Seth Levy, Director of Bioprocess Development at Modalis Therapeutics

Seth Levy, PhD, joined Modalis Therapeutics in 2021 as Director of Bioprocess Development to build and oversee internal process development and analytics efforts, as well as manage external manufacturing. Prior to Modalis, Seth led teams in Manufacturing Science and Technology and Small-Scale Development for AAV and LV manufacturing at Brammer Bio/Patheon Viral Vectors Services. Seth worked in gene therapy R&D before his time at a CDMO and drove numerous AAV projects including basic biology research, capsid engineering, and translational gene therapy approaches at Sanofi Genzyme and academia. Seth was a postdoctoral research fellow at Brigham and Women’s Hospital and Harvard Medical School after completing his PhD at the University of Alabama at Birmingham.

Followed by Streamlining AAV Characterization with Mass Photometry

The presence of inactive, empty capsids in potentially large quantities is one of the main challenges in AAV production. Quantifying the ratio of empty to full AAV capsids is currently challenging; existing methods are not quick and simple enough to be employed throughout the process. Mass photometry is an easy-to-use bioanalytical technology that measures the empty/full AAV capsid ratio in minutes using minimal sample amounts and without the need for sample preparation. By circumventing the requirement of a large capital expense and skilled operators, it can be employed throughout the development and manufacturing processes. Here, we present the mass photometry instrument dedicated to the challenges of AAV characterization, SamuxMP, and the coming software to enable its use in GMP-regulated environments.

Presented by Gael Nicolas, Senior Technical Sales Specialist at Refeyn

Followed by Streamlining AAV Characterization with Mass Photometry.
Presented by Gael Nicolas, Senior Technical Sales Specialist at Refeyn

Gael completed his B.S. in microbiology and M.S. in molecular medicine at the University of South Florida, where his research areas were in both chemotherapeutic drug delivery systems and biofilm formation in B. henselae. He completed a M.S. in biochemistry, and cell and molecular biology at Cornell University in Dr. Pamela Chang’s lab, working on characterizing the gut microbiome-host interaction via metabolomic analysis of bacterial metabolites. Gael joined Refeyn in January 2021 as a sales and applications specialist where he currently provides support to researchers across the U.S. that are using Refeyn’s groundbreaking technology of mass photometry.

Sponsored by Refeyn

Refeyn. Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand for These Viral Vector Delivery Systems.

Refeyn, the mass photometry pioneer, offers new capabilities to characterise the function, structural composition, and dynamics of biomolecules. Refeyn instruments measure the mass of individual molecules directly in solution, quickly and simply revealing the true behaviour of molecules in near-native environments. The diverse applications of mass photometry include quantitative analysis of sample purity and homogeneity, biomolecular complex assembly and disassembly, the strength and kinetics of molecular interactions, and more. Refeyn was spun out of Oxford University in 2018 to make mass photometry available globally. Its technology has now been rapidly adopted across academia and industry, where it is transforming biomolecular characterisation. The TwoMP, Refeyn’s mass photometer, brings the technology into everyday laboratory life, enabling molecular measurements with unprecedented speed and simplicity. It uses proprietary technology to detect the light scattered by single molecules in solution, delivering label-free mass measurements over a broad mass range with high precision and exquisite sensitivity.


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