Considerations in Rapid Scale-Up of Vaccine Manufacturing Processes
Vaccine manufacturing processes must be developed and scaled up quickly to meet market demand in case of emerging disease or pandemic. To insure efficient scale up, suitable process and analytical methods need to be in place. Product manufactured at the new scale and location should be rigorously evaluated to demonstrate biochemical and immunological comparability. Scalable influenza manufacturing approaches and methods for implementing rapid changes in manufacturing process scale are described.