Use of Critical Process Parameters and Quality by Design to Improve Biopharmaceutical Product Quality
Presented at: 2008 PDA Development and Regulation of Clinical Trial Supplies Conference, Cambridge, MA November 11, 2008
Quality by Design in biopharmaceutical manufacturing processes includes the identification of critical process steps and parameters and the use of rational design to reduce risk and increase product quality. Using previous knowledge of process performance, product quality, and comparable process issues can help identify materials or operations that may impact product quality and safety in similar products or production systems. It can help in developing reliable, robust processes to address each potential risk area. Overall product quality may be improved through the use of Quality by Design not only to improve overall product quality but also reduce costs and speed candidate products through clinical development.