: Establishing a "Design Space" where process parameters can vary without affecting product quality.
: In some QbD models, real-time data can potentially replace traditional end-product testing. Summary of Key Findings A Mab A Case Study In Bioprocess Development
Two polishing steps were tested:
The primary goal of the study is to provide a "roadmap" for using to develop a manufacturing process. Instead of traditional "fixed" processes, it advocates for a deep understanding of how process parameters affect the final product's safety and efficacy. 2. Key Development Stages : Establishing a "Design Space" where process parameters