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Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

Summary

  • 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 scale up strategy

  • Identifying choked flow conditions, and designing a cycle to prevent choked flow from occurring

Overview

Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing.  Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers.   Without understanding the scientific principles behind scale-up and cycle transfer, many companies will try tweaking the cycle parameters when problems are encountered during scale-up.  While this approach may work occasionally, often, it will lead to additional problems such as excessively long cycle times, shattered vials, higher residual moisture content, etc.

Who should attend?

  • Quality Control Scientists

  • Development Scientists

  • Production Management

  • Quality Assurance

J. Jeff Schwegman, Ph.D.

Expert

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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