MONITORING OF BATCH PHARMACEUTICAL FERMENTATIONS: DATA SYNCHRONIZATION, LANDMARK ALIGNMENT, AND REAL-TIME MONITORING

摘要

Most batch pharmaceutical fermentations have successive phases of operation. Detection of process phase landmarks is important for improving the performance of process monitoring and control. This study considers techniques for adjustment of batch data lengths to match landmarks of phases during the progress of the batch. Time synchronization and landmark alignment techniques are presented and their integration with on-line monitoring is discussed through illustrative examples.