Characterization of Host Cell DNA Impurities in AAV Products: A Product Specific Qualification Method & DNA Fragment Size Assessment

• rAAV as a Gene Therapy Product
• Gene Therapy Critical Quality Attributes (CQA)
• Overview Methods for Residual Host Cell DNA Quantification
• Method Development for Residual Host Cell DNA Quantification
• Residual Host Cell DNA Sizing in rAAV Gene Therapy Product

Speakers:

Amy Hsu

Principal Research Associate, Analytical Development

Astellas Gene Therapies