Translation 2: Process Scale-Up

Increasing the production scale of a product in development from lab to pilot then on to full scale is an important aspect to manage correctly during the transition of a product from the laboratory to manufacturing. It requires careful planning, execution and monitoring to ensure the development of a robust and reproducible GMP process. This module will outline and build an understanding of planning, designing and how to conduct representative pilot scale operations, the demonstration of process scalability, identification and how to address potential issues before commencing full-scale production.