GMP-LAB-2023

Join QuTEM and Eli Lilly on December 2, 2026, for an in-depth session on optimizing AAV gene therapy analytical methods.

AAV-based gene therapy samples are inherently heterogeneous, often composed of capsid monomers, aggregates, and fragment species. Accurately tracking and characterizing these size-variant populations is crucial for delivering a consistent, high-quality product to patients and deeply understanding aggregation assay readouts.

QuTEM is thrilled to announce a joint educational webinar featuring Rickard Nordström, Chief Operating Officer at QuTEM, and Margaret Butko, Ph.D., Senior Advisor of CMC Assay Development at Eli Lilly and Company.

This session will explore a practical framework for selecting the right aggregation assays based on the specific context — whether for product release, in-process testing, characterization, or early-stage discovery.

Whether you are navigating early discovery or post-commercialization testing, this session will provide actionable insights into characterizing complex AAV products.

What you will learn

Assay selection framework

How to weigh critical parameters including specificity, precision, accuracy, throughput, and platform compatibility.

Evaluating assay performance

Insights into a reproducible forced-aggregation protocol for generating small, soluble capsid aggregate controls used to assess performance across TEM, AUC, SEC, SEC-MALS, and FFF-MALS.

Real-world application

A detailed case study summarizing the evaluation of eight different aggregation assays to empirically determine which methods are best suited for each context.

Webinar details

Wednesday, Dec. 2, 2026

9.30 AM EST | 3.30 PM CET

Related AAV analyses

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