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Evaluation of AAV Aggregation & Capsid Load (Empty / Full) CQAs Using Novel 700 Å SEC Column

This event is now available on demand.

Event Overview:

AAVs are attractive vehicles for targeted drug delivery. There are numerous critical quality attributes (CQAs) that are evaluated to ensure the 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, the 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 Objectives:
  • Learn how to optimize AAV aggregate analysis.
  • Learn how SEC is utilized for capsid load quantification.
  • Learn how optimized column specifications improve CQA data quality.
Who Should Attend:
  • Biopharmaceutical researchers: Professionals involved in the development and optimization of AAV-based drug delivery systems.
  • Quality control professionals: Individuals responsible for ensuring the safety and efficacy of AAV products by monitoring and evaluating critical quality attributes.
  • Analytical development scientists: Scientists focusing on the analysis and characterization of biological molecules, particularly those using size exclusion chromatography and related techniques.

Featured Speakers

Ramkumar Dhandapani, PhD
Ramkumar Dhandapani, PhD
Senior Product Manager
Phenomenex


Ramkumar Dhandapani, PhD, has been in the chromatography industry for over 20 years with hands-on and troubleshooting experience. He earned master’s and doctoral degrees in analytical chemistry from Seton Hall University with specialization in microextractions, multidimensional chromatography and tandem mass specs techniques. He has developed and validated several regulatory compliant methods in the pharmaceutical, food, fuels, and environmental industries and has incorporated method improvement and troubleshooting across a range of separation techniques. Dr Dhandapani joined Phenomenex in August 2014 and serves as a senior product manager. In addition to managing the product line, he presents on innovations in chromatography at various chromatography conferences.

Speaker's Email: ramkumard@phenomenex.com
 

Claire Butré, PhD
Claire Butré, PhD
R&D Technical Leader
Quality Assistance


After earning an engineering degree in chemistry from the National Graduate School of Chemistry in Mulhouse, France, Claire Butré, PhD, earned her doctorate in the laboratory of food chemistry of Wageningen University & Research in the Netherlands, where she specialized in the analysis of proteins by mass spectrometry. She then worked at Wageningen University & Research as a researcher on several LC-MS method development projects for different applications. She joined Quality Assistance in 2018 as an R&D scientist and has been R&D technical leader since 2021. She and her team are involved in the development of new analytical techniques for the characterization of therapeutic proteins and new modalities (AAVs or mRNA), with a focus on liquid chromatography coupled to UV or MALS detectors and on mass spectrometry.



For any technical questions please contact David Ambrose: dambrose@mjhlifesciences.com