Critical Process Parameters in Oligonucleotide Manufacturing: Strategies for Control During Scale-Up
Time: 3:30 pm
day: Day One PM
Details:
• Emphasizing the importance of early identification of Critical Process Parameters
(CPP) to enable effective control strategies that ensure consistent product quality and
compliance
• Developing robust and predictive down-scale models to accurately illustrate large scale
manufacturing and minimize risk of unexpected results during scale up
• Case studies highlighting the impact of insufficient CPP control: common pitfalls and
establishing effective control frameworks
