A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity in the Case Study involved a scale up of freeze-drying capacity, improvements such as point-of-fill filtration and optimization of the existing lyophilization cycle. In addition, it was decided to robustly determine intra- and inter-batch variability and use a systematic QbD approach to comply with recent FDA guidelines.
Download this Case Study to see how non-destructive headspace moisture analysis of statistically relevant sample sets was used to execute a Design of Experiments (DoE) in small-scale.