MAY 17, 2022 9:00 AM PDT

On the way towards personalized medicine: Gene therapy AAV characterization by capillary electrophoresis (CE) and liquid chromatography mass spectrometry (LC-MS)

Sponsored by: SCIEX
Speakers

Abstract
Date:  May 17, 2022
Time: 9:00am (PDT),  12:00pm (EDT), 8:00pm (CEST)
 
Gene therapeutics have great potential to treat many severe diseases in an unprecedented, targeted manner. The biopharmaceutical industry is rapidly expanding its capabilities to discover, design and develop these novel therapeutics. Analytical platform methods have proven to be valuable tools in biopharmaceutical processes increasing efficiency. Prior to regulatory submission, there are many aspects that require extensive characterization, including the carrier and the genetic material as well as related impurities. This presentation evaluates AAV gene therapy product characterization from the viral proteins to the genetic material, including capabilities for analyzing both, product- and process-related impurities using SCIEX CE and LC-MS analytical platform strategies.
 
Learning Objectives
  • How to ensure and monitor viral capsid, viral protein and transgene integrity reproducibly with platform methods
  • How to characterize product- and process related impurities of AAVs for viral proteins and genome
  • How to determine critical quality attributes, such as high-risk residual nucleic acid analysis posing a safety concern and post-translational modifications impacting the efficacy of the viral carrier
 
 
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