Successful Control Strategies (Part 2)

Case study

Demonstrating control over the manufacturing process is a key element of the Quality by Design (QbD) model. In Part I of ‘Successful control strategies’, we discussed Cambrex’s capabilities in determining CPPs and PARs to pinpoint manufacturing steps that require tighter control. We continue our discussion of these late-stage QbD studies by exploring the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

Download part two of our case study to learn how Cambrex approaches fate and purge studies, and how they contribute to readiness for commercialization.