ABSTRACT
Biopharmaceutical Industry and PAT ................................................. 11 2.3 Achieving PAT Objectives in Practice ............................................................ 14 2.4 Strategic Vision for Biopharmaceutical Manufacturing ................................. 15
2.4.1 Process and Data Acquisition ............................................................. 16 2.4.2 Information Processing ....................................................................... 17 2.4.3 Process/Product Quality Control ........................................................ 18 2.4.4 Process Monitoring and Improvements .............................................. 19
2.5 Example of PAT Implementation: On-Line Control of Glycosylation during Monoclonal Antibody Production .......................................................20 2.5.1 Process and Data Acquisition ............................................................. 21 2.5.2 Information Processing .......................................................................22 2.5.3 Process/Product Quality Control ........................................................23
