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

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.

 

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