This executive summary explores a risk-based approach to process qualification, demonstrating how small-scale experiments can mitigate risk and reduce material consumption. It also delves into product design considerations and how a risk-based approach can lead to robust processes with built-in flexibility.
In the Lonza's webinar you can gain valuable insights and learn more about how process design and qualification can be used to create a validation strategy that provides robust and flexible small-molecule drug product manufacturing.