Overcoming AAV aggregate analysis challenges using a novel size exclusion column to determine CQAs
Apr
3
2024
On demand

Overcoming AAV aggregate analysis challenges using a novel size exclusion column to determine CQAs

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Overcoming AAV aggregate analysis challenges using a novel size exclusion column to determine CQAs

As the most widely used viral vector for gene therapies, Adeno-Associated Viruses (AAVs) present unique advantages, including their ability to enter both dividing and non-dividing cells, the absence of human viral illness, and minimal immune response triggers.

However, the complexity and size of AAVs pose challenges for their analysis. Traditional approaches struggle with their larger size, hindering comprehensive characterization crucial for ensuring the safety, efficacy, and functionality of gene therapies. This is particularly true for aggregate analysis testing, which is a critical quality attribute (CQA). This challenge accompanies others including long run times, high sample consumption where sample quantities are limited, and accurate quantitation of monomer and aggregate species.

In this webinar, Senior Research Scientist, Shilin Cheung, will review optimization of high throughput size exclusion chromatography methods using a novel 700 Å pore size SEC chemistry to reduce sample consumption and run times. Additionally, method versatility with multiple mobile phase conditions utilizing various detectors across several AAV serotypes will be explored.

  • Learn how a novel 700 Å pore size SEC chemistry improves lab throughput and reduces sample consumption for AAV aggregate analysis
  • Review of method optimization best practices to maximize AAV monomer/aggregate resolution
  • Learn how selecting appropriate particle chemistry, pore size, and hardware improves SEC performance for AAV analysis
Shilin Cheung
Shilin Cheung
Senior Research Scientist at Phenomenex

Dr Cheung received her BS (2006) and PhD (2012) in Bioanalytical Chemistry from the University of Toronto. She has developed, qualified, and validated innovative analytical methods in capillary electrophoresis based microfluidics, automated low volume UV-vis spectroscopy, and ultra-high-performance liquid chromatography assays. Her methods have been applied to manufacturing process developments, formulation and stability and drug substance/drug product characterization and specification testing. At Phenomenex, she is focused on developing fit for purpose analytical methods to help advance developments in gene therapeutics.

Ramkumar Dhandapani
Ramkumar Dhandapani
Senior Product Manager at Phenomenex

Dr Dhandapani has been in the chromatography industry for over 20 years with hands-on and troubleshooting experience. He has earned a Master's 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 the Pharmaceutical, Food, Fuels, and Environmental industries as well as incorporated method improvement and troubleshooting across a range of separation techniques. Dr Dhandapani joined Phenomenex in August of 2014, where he serves as a Senior Product Manager. In addition to managing the product line, Dr Dhandapani presents on innovations in chromatography at various chromatography conferences.