Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
- Critical parameters in scale-up and cycle transfer
- Scale-up strategy
- Mapping studies
- Dryer configuration
- Determining and preventing choked flow conditions
Understanding the differences between development, pilot, and productions dryers
Proper information gathering (IO, OQ, manufacturer specifications, operator knowledge, etc.)
Design and execution of a well thought out
Identifying choked flow
conditions,and designing a cycle to prevent choked flow from occurring
Lyophilization cycle scale-up and cycle transfer between dryers
J. Jeff Schwegman, Ph.D. iscurrently the founder and chief executive officer of AB BioTechnologies(www.ab-biotech.com) where he develops formulations, lyophilization cycles,determines residual moisture by Karl Fischer, and provides thermalcharacterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes inspeaking and consulting in parenteral pre-formulation, formulation, analytical,and lyophilization of both small molecules and large biomolecules. He also holds patents and develops newtechnologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in1992 and began working at Cook Imaging in Bloomington Indiana, where he gainedexperience in analytical, formulation and process development.
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