Evaluation of AAV Aggregation & Capsid Load (Empty / Full) CQAs

AAVs are attractive vehicles for targeted drug delivery. There are numerous Critical Quality Attributes (CQAs) evaluated to ensure safety and efficacy of AAVs. Aggregation is a CQA and should be controlled as AAVs are prone to aggregation from freeze thaw cycles during storage.

• In this webinar, we will explore CQAs using a novel size exclusion column optimal for AAV analysis, which enables the separation of AAV monomer from aggregate species with excellent peak shape, resolution and peak profile to provide better data quality. Due to both the inert surface chemistry and flow-path in the BiozenTM dSEC-7 column, the analysis conditions were independent of the serotype showcasing the utilization of platform methodology.
• In addition to calculating the aggregation level, aggregate molar mass, molar masses of protein and nucleic acid, and extinction coefficients of capsid and DNA were also determined. The novel particle chemistry of Biozen dSEC-7 provides instant stabilization of sensitive detectors like MALS to provide quality data.
• Additionally, Full-to-Empty capsid ratio was determined to accurately predict capsid load demonstrating Biozen dSEC-7’s utility as a holistic solution for the determination of CQAs of AAVs.

Key Learning Points:

• Learn how to optimize AAV aggregate analysis.
• Understand how size exclusion can be effectively utilized for capsid load quantification.
• Find out how optimized column specifications can improve data quality to determine critical quality attributes

Who should attend?

Any scientist, associate or manager that optimizes AAV aggregate analysis methods.

Presenter: Claire Butré, PhD, (R&D Technical Leader, Quality Assistance & Ramkumar Dhandapani, PhD, Senior Product Management, Phenomenex)