QbD And PAT In Biopharmaceutical Development

This eBook is a compilation of articles from industry experts that

• Presents a practical roadmap that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle to first determine and then refine criticality;
• Gives insight about the implementation of QbD and PAT tools in biopharmaceutical manufacturing;
• Shows how process controls get some upgrades to better reflect real-time conditions and understand how multivariate data analysis and Design-of-Experiment techniques enable biopharmaceutical companies to improve their efficiency
• Details how multivariate data analysis and Design-of-Experiment techniques enable biopharmaceutical companies to improve their efficiency and ultimately speed data analysis and development, reduce process-related costs, and reduce time to market.

Originally published by BioPharm International