Description
This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products – and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field. 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 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 Bourls, Gael de Lannoy, Bernadette Scutell, 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
