AAV Characterization in Gene Therapy Manufacturing

Utilizing CE-SDS and icIEF methods for rAAV Characterization in Gene Therapy Manufacturing 

Viral vectors intended for commercial use in gene therapy must meet increasing regulatory standards for product and process-related impurities, and extensive characterization of the drug product is essential. 

Dr. Chris Heger (Bio-Techne) will provide a short overview of how CE-SDS and icIEF methods can be used for capsid protein characterization and analysis of in- process manufacturing attributes using the Maurice™ platform. The featured speaker, Dr. Ana Carreras González (Viralgen) will describe the utilization of different analytical methods based on capillary electrophoresis to assess rAAV purity, identify process-related impurities and to study batch stability to characterize gene therapy product quality. She will discuss the development of CE-SDS and icIEF analytical techniques using the Maurice instrument to help meet GMP standards and perform successful validations. She will demonstrate how these techniques can help enable Quality Control for rAAV manufacturing. 

What attendees will learn:

• How CE-SDS and icIEF techniques can be used to assess rAAV purity and batch stability 
• How leveraging these techniques can help enable Quality Control for gene therapy manufacturing. 
• How the Maurice system can be used to analyze multiple attributes, including: capsid protein PTM screening (deamidation), capsid fractionation for MS analysis, capsid stability, protein VP 1,2,3 ratios and purity, capsid serotype, empty/full assessment, potency and more.