De-risking AAV development: from upstream optimization to regulatory-ready testing

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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De-risking AAV development: from upstream optimization to regulatory-ready testing

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Decisions made before analytical testing begins increasingly determine whether AAV and lentiviral vector (LVV) programs meet regulatory expectations for quality, consistency, and potency.

This session shows how upstream process optimization, raw material selection, and a well-planned analytical strategy work together to improve vector quality, reduce CMC risk, and shorten development timelines. Attendees will gain practical guidance on building scientifically justified testing strategies for cases where regulators do not prescribe fixed limits.

Attend this webinar to learn about:

How Design-of-Experiments-driven upstream optimization influences vector yield and packaging efficiency and drives downstream product quality
How critical raw materials quality (plasmid and transfection reagent) influence manufacturing consistency and batch-to-batch reproducibility across AAC and LVV
How to build a regulatory-ready AAV/LLV analytical testing strategy based on better understanding of what regulators expect and what is left open to scientific justification when specifications are not explicitly defined

David Stewart

Team Lead, Biophysical Services at Sartorius

David Stewart leads the Biophysical Services team, supporting the analytical characterization of advanced therapies and protein therapeutics. With a strong background in protein analysis and regulatory testing, David has extensive experience generating critical quality data and supporting product development throughout the drug lifecycle. At Sartorius, he works closely with customers to deliver robust characterization strategies that help accelerate development, ensure product quality, and support regulatory requirements from early-stage research through commercialization.

Jordan Magisson

Scientific Support Specialist at Sartorius

Jordan holds a PhD in Life and Health Sciences and a Master’s degree in Pharmacology. He began his career at the start-up Defymed, contributing to the development of an innovative cell encapsulation device for type 1 diabetes and gaining solid experience as a Research Engineer and R&D Manager across several European projects. Jordan joined Sartorius Polyplus in 2024 as a Scientific Support Specialist, where he works closely with scientists to optimize their transfection applications, making transfection a central focus and key area of his expertise.

In 29 Days

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