ABSTRACT
Characterization Studies .............................................. 33 3.3 Precharacterization Work ............................................. 33
3.3.1 Historical Data Review and Risk Assessment ................................................. 34
3.3.2 Scale-Down Model Qualification ....................... 39 3.4 Process Characterization Studies ................................ 46
3.4.1 Impurity Clearance ............................................ 46 3.4.2 Screening Experiments ...................................... 47 3.4.3 Interactions between Key Parameters
(The Next Round of Process Characterization Experiments) ......................... 54
3.4.4 Key and Critical Parameters............................. 60 3.4.5 Setting Acceptance Criteria for In-Process
Performance Parameters: Using Feed Quality as a Process Input ................................ 61
3.5 Finishing Up: Reports, Follow-Up, etc. ........................ 64 3.6 Future Challenges......................................................... 64 Acknowledgments................................................................... 66 References............................................................................... 66
3.1 INTRODUCTION
Although considered to be a significant time and resource commitment from Process Development, process characterization has been shown to be valuable in ensuring validation and manufacturing success. Given the expense of producing biopharmaceuticals at large scale, process characterization gives an excellent return on investment over the lifetime of a product or process. Inadequate process characterization can result in costly lot failures and incidents, failed validation runs, and difficult inspections [1].
