1. Characterization of Formulations for Freeze Drying
Kevin R. Ward and Paul Matejtschuk
2. Formulation and Process Development for Lyophilized Biological Reference Materials
Paul Matejtschuk, Kiran Malik, and Chinwe Duru
3. Controlled Ice Nucleation Using ControLyo(R) Pressurization-Depressurization Method
Jacob Luoma, Graham Magill, Lokesh Kumar, and Zakaria Yusoff
4. Alternative Methods of Controlling Nucleation in Freeze Drying
Roberto Pisano
5. Tunable Diode Laser Absorption Spectroscopy in Lyophilization
William J. Kessler and Emily Gong
6. Containment Options for the Freeze-Drying of Biological Entities and Potent Materials
Chris Cherry
7. Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS(TM))
Maik Gutzeitt, Carolin Wolf, Johannes Selch, and Thomas Beutler
8. Regulatory Aspects of Freeze Drying
David Awotwe-Otoo and Mansoor Khan
9. Container and Reconstitution Systems for Lyophilized Drug Products
T. Page McAndrew, Douglas Hostetler, and Frances L. DeGrazio
10. Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT) and Statistical Analysis
Erwan Bourlès, Gael de Lannoy, Bernadette Scutellà, Fernanda Fonseca, I. Crostoam Trelea, and Stephanie Passot
11. Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development
Geoff Smith and Evgeny Polygalov
12. Lyophilization of High-Concentration Protein Formulations
Patrick Garidel and Ingo Presser
13. Mechanical Behavior and Structure of Freeze Dried Cakes
Sarah H.M. Hedberg, Sharmila Devi, Arnold Duralliu, and Daryl R. Williams
14. High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids
Karthik Balakrishna Chandrababu, Rajashekar Kammari, Yuan Chen, and Elizabeth M. Topp