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Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method

  • Jacob Luoma
  • Graham Magill
  • Lokesh Kumar
  • Zakaria Yusoff
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

Controlling the ice nucleation temperature during the freeze phase of lyophilization is an area that has grown significantly in importance in the recent past. Different Controlled Ice Nucleation (CIN) techniques investigated in the pharmaceutical industry are discussed in this chapter, along with their limitations for commercial implementation. Recent work using the ControLyo® pressurization and depressurization technology is further discussed, along with a discussion of CIN cycle design. This book chapter also explores how ControLyo® CIN technology could be used to enable a Quality by Design (QbD) approach for the freeze phase of lyophilization cycles.

Key words

Freeze drying Lyophilization Ice nucleation Controlled ice nucleation ControLyo® Technology Quality by design QbD Mechanistic understanding 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Jacob Luoma
    • 1
  • Graham Magill
    • 1
  • Lokesh Kumar
    • 1
  • Zakaria Yusoff
    • 2
  1. 1.Genentech, Inc.South San FranciscoUSA
  2. 2.SP ScientificWarminsterUSA

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