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Evaluation of AAV Aggregation & Capsid Load (Empty / Full) CQAs
Claire Butré, PhD
R&D Technical Leader, Quality Assistance
Ramkumar Dhandapani, PhD
Senior Product Management, Phenomenex
Tuesday, June 4, 2024
10:00 AM - 11:00 AM (PT)
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.
Who Should Attend:
  • Any scientist, associate or manager that optimizes AAV aggregate analysis methods
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 
Speaker Bios:
Claire Butré, PhD
After an Engineering Degree in Chemistry obtained from the National Graduate School of Chemistry in Mulhouse, France, Claire did her PhD in the laboratory of food chemistry of Wageningen University in the Netherlands, where she specialized in the analysis of proteins by mass spectrometry. Then, she worked at Wageningen University 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 is now R&D Technical Leader since mid-2021. She and her team are involved in the development of new analytical techniques for the characterization of therapeutic proteins as well as new modalities (AAVs or mRNA) with a focus on liquid chromatography coupled to UV or MALS detectors and on mass spectrometry.

Ramkumar Dhandapani, PhD
Dr. Dhandapani has been in the chromatography industry for over 20 years with hands-on and troubleshooting experience. He has earnt a Masters and PhD degree in Analytical chemistry from Seton Hall University with specialization in Microextractions, Multidimentional Chromatography and Tandem Mass Specs techniques. He has developed and validated several regulatory compliant methods in Pharmaceutical, Food, Fuels and Environmental industry as well as incorporated method improvement and troubleshooting across a range of separation techniques. Dr. Dhandapani joined Phenomenex in August of 2014 and he serves as a Senior Product Manager at Phenomenex. In addition to managing the product line, Dr. Dhandapani presents on innovations in chromatography at various chromatography conference.

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