AAV Analytics: Key Considerations When Developing A Clinical Program

Inadequate analytical development and process validation pose significant challenges for advanced therapies, particularly AAV gene therapies. At Andelyn, we prioritize method validation throughout our development and manufacturing pipelines. As production scales, rigorous adaptation and development of research-derived assays ensure compliance with Good Manufacturing Practice (GMP) standards for plasmid and viral vector production.

Recognizing the critical need for product comparability over time, our dedicated quality control team meticulously executes GMP-compliant analytics for clinical-phase production. These efforts not only guarantee consistency in workflows, reagents, and processes but also ensure that assays meet stringent regulatory requirements and deliver reliable data throughout the manufacturing process.

Finding expert partners with the necessary skills to optimize AAV processes is crucial for minimizing variability and risk. Join Andelyn's webinar to explore key considerations for advancing your AAV gene therapy from concept to commercialization, leveraging the power of advanced analytics.