Xiaotong Fu, Ashish Sharma, Andrew D Tustian, Eugene Sun
In this expert roundtable, four highly experienced industry professionals discuss key considerations in developing an AAV purification process, highlighting the importance of early-stage planning and robust process design. The panelists share insights on QbD approaches in gene therapy development, process intensification, and ensuring sufficient flexibility to adapt platforms for different AAV serotypes while maintaining efficient processes and regulatory compliance.
