Search results for " design-space"
Article
Essentials in Establishing and Using Design Space
Methods for Design-Space Generation
Design-space generation always begins with CQAs, risk assessments, definition of materials, process sequence, scale, and equipment (see Figure 2). Experiments are…
Article
Application of Quality by Design to Viral Safety
There will be instances when the design-space concept may intersect with the development of modular viral clearance claims. For companies with robust pipelines using closely related manufacturing meth…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…ssifying of criticality, levels of details required in process descriptions and in risk assessments, design-space verification, and changes to non-critical process parameters (non-CPPs).
Other …
Article
QbD and PAT in Upstream and Downstream Processing
Vanden Boom (Hospira): The enhanced design-space knowledge derived from the systematic risk assessments and design of experiment (DOE) work completed in association with a QbD approach offers the pote…