CMC Strategies for Ensuring AAV Vector Potency and Infectivity in Gene Therapy
Time: 2:30 pm
day: Conference Day Two
Details:
- Potency Assays for AAV Vectors: Discuss the development and validation of reliable potency assays to ensure that AAV vectors retain their ability to effectively transduce target cells and deliver the therapeutic gene
- Balancing Yield and Infectivity: Address the challenges of maximizing viral yield without compromising infectivity, focusing on process optimization, transfection efficiency, and the importance of maintaining high-quality vector production
- Quality Control and Regulatory Alignment: Highlight best practices for aligning manufacturing processes with regulatory expectations for quality control, potency testing, and infectivity assessments in clinical development
