Output details

Anticipation of scale up issues in pharmaceutical development

This innovative application of risk assessment to “right-first-time” scale-up (SURE) in the pharmaceutical manufacturing industry resulted in new development activities on more than 70 Astra Zeneca primary manufacturing processes across all its development sites (Katie.Murray@astrazeneca.com). An assessment based on SURE is used in Johnson-Matthey (hugh.stitt@matthey.com). Within Astra Zeneca SURE is now adapted for the scale up of secondary formulation processes. Through a structured discussion of the process and scale-up risks the invention of SURE has driven the integration of engineers, chemists and formulators in development teams. Industry sees this as essential for implementation of Quality-by-Design and sustainable development.