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
