Paving the way to a successful AAV product

Analytical methods for AAV characterisation, quality attributes for manufacturing and orthogonal approaches for infectivity and capsid ratios.

November 20th, 2024

4pm (CET) / 10am (ET)

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OVERVIEW

Adeno-associated viruses (AAVs) are versatile vectors serving as the leading platform in gene therapy.

In this webinar, Prof. Dr. Susumu Uchiyama will provide an overview of today’s state-of-the art analytical methods for AAV characterization and address key parameters to monitor during process development in AAV manufacturing. Prof. Uchiyama will discuss the rationale behind selecting individual methods for each quality attribute explaining how these analytical approaches contribute to the optimization of the manufacturing process and the assurance of product quality.

Subsequently, Dr. Melanie Schwerdtfeger will present case studies highlighting the measurement of AAV infectivity and the full-to-empty capsid ratio by orthogonal methods such as analytical ultracentrifugation and mass photometry as part of drug product development.

Addressed Challenges

01Selecting the right analytical methods to characterise AAV vectors across multiple quality attributes during manufacturing and drug product development.

02Monitoring the critical quality attributes that must be controlled during AAV manufacturing to consistently achieve high-quality gene therapy products.

03Measuring AAV infectivity and full-to-empty capsid ratios accurately using orthogonal methods that do not depend on the encoded therapeutic protein.

WHAT YOU WILL LEARN

01Identify which analytical methods are appropriate for characterising AAVs at each stage of manufacturing and drug product development programmes.

02Understand which quality attributes must be monitored during AAV manufacturing to ensure product quality and support regulatory submissions.

03Learn how to measure AAV infectivity independently of the encoded therapeutic protein using techniques such as analytical ultracentrifugation.

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SPEAKERS

Prof. Dr. Susumu Uchiyama

University of Osaka, Umedico; Scientific Advisor of Coriolis Pharma

Prof. Dr. Susumu Uchiyama is a biophysical chemist with over 25 years of experience, currently a biotechnology professor at Osaka University since 2017. His research focuses on the biophysics of proteins, protein complexes, and protein-nucleic acid complexes using methods like analytical ultracentrifugation, native mass spectrometry (MS), and calorimetry. He has contributed to the development of analytical instruments and prototypes. In 2005, he worked on native MS at Prof. Carol Robinson's lab at Cambridge University. He founded U-Medico Inc. in 2006, offering analytical services since 2008. His interests include immune-related proteins, therapeutic protein formulations, and gene therapy products. He leads a national project on virus vector characterization and quality control for gene therapy. Prof. Uchiyama has published over 250 papers, edited a book, and serves on editorial boards of major journals.

Melanie Schwerdtfeger Ph.D

Coriolis Pharma; Scientist ATMP formulation

Dr. Melanie Schwerdtfeger studied molecular medicine at the University of Regensburg, Germany with a focus on immunology and viral vaccine vectors. She received her PhD in biochemical and biotechnological sciences from the University of Campania “Luigi Vanvitelli”, Naples, Italy in collaboration with the Ludwig-Maximilians-Universität in Munich, Germany. During her PhD she gained expertise in the field of cancer immunotherapy working on a modular platform for adoptive T cell therapy and characterizing a novel chimeric antigen receptor. In 2021 she joined Coriolis as scientist in the ATMP group and is currently responsible for potency assay development.

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