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Development Reports

  • What goes into your lyophilization development report?

  • As a first step, we discuss with you the process and logic for the cycle.

  • We recommend a sound rational for any scale-up processes or changes in equipment.

  • A thorough analysis of each development run is critical to rationalize final cycle design.

  • Not only must your cycle function, but there must also be understanding about why it is what it is.

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© 2005 Narlin Bennet Beaty, Ph.D.