1、Biopharma PAT Quality Attributes,Critical Process Parameters&Key Performance Indicators at the Bioreactor2ContentBiopharma PAT:Quality Attributes,Critical Process Parameters&Key Performance Indicators at the Bioreactor05.May 202413245678PAT Building Blocks 5PAT for Biopharma 8Culture&Fermentation Pr

2、ocess Types 11Monitoring Methods 14Critical Process Parameters 17Critical Quality Attributes&Key Performance Indicators 23Conclusions 31References 333456123Intelligent Arc Sensors for pH&DO In-Situ Measurement 18Dissolved Oxygen Users Experiences 19 Real-time Monitoring of DCO2 During Cell Culture f

3、or mAb Production 20In-Situ Cell Density for Batch&Perfusion mAb Production 26Validation of Density Measurement for Different Cell Types 27The Benefits of Monitoring Cell Density During Various Applications 29Biopharma PAT:Quality Attributes,Critical Process Parameters&Key Performance Indicators at

4、the Bioreactor05.May 2024Focus Spots4Biopharma PAT:Quality Attributes,Critical Process Parameters&Key Performance Indicators at the Bioreactor05.May 2024AbstractThis white paper introduces the concepts of Process Analytical Technology(PAT)in the context of Upstream Biopharma processes,focusing on th

5、e significance of Quality Attributes,Critical Process Parameters,and Key Performance Indicators at the Bioreactor.The PAT initiative is recommended by the US FDA as a strategy to minimize the risks associated with pharmaceutical product manufacturing.At Hamilton Process Analytics,we believe that mon

6、itoring and controlling several Critical Process Parameters and Key Performance Indicators greatly improves the reliability,efficiency,and productivity of bioproduction processes.In this white paper,we present real-world applications and case studies,showcasing the practical implications of implemen