Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches

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. Front Matter ....Pages i-xiv Characterization of Formulations for Freeze-Drying (Kevin R. Ward, Paul Matejtschuk)....Pages 1-32 Formulation and Process Development for Lyophilized Biological Reference Materials (Paul Matejtschuk, Kiran Malik, Chinwe Duru)....Pages 33-55 Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method (Jacob Luoma, Graham Magill, Lokesh Kumar, Zakaria Yusoff)....Pages 57-77 Alternative Methods of Controlling Nucleation in Freeze Drying (Roberto Pisano)....Pages 79-111 Tunable Diode Laser Absorption Spectroscopy in Lyophilization (William J. Kessler, Emily Gong)....Pages 113-141 Containment Options for the Freeze-Drying of Biological Entities and Potent Materials (Chris Cherry)....Pages 143-155 Freeze-Drying Systems: Freeze Dryer Interface Design Requirements and Automatic Loading and Unloading Systems (ALUS™) (Maik Guttzeit, Carolin Wolf, Johannes Selch, Thomas Beutler)....Pages 157-172 Regulatory Aspects of Freeze-Drying (David Awotwe-Otoo, Mansoor Khan)....Pages 173-192 Container and Reconstitution Systems for Lyophilized Drug Products (T. Page McAndrew, Douglas Hostetler, Frances L. DeGrazio)....Pages 193-214 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, Ioan Cristian Trelea, Stephanie Passot)....Pages 215-240 Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development (Geoff Smith, Evgeny Polygalov)....Pages 241-290 Lyophilization of High-Concentration Protein Formulations (Patrick Garidel, Ingo Presser)....Pages 291-325 Mechanical Behavior and Structure of Freeze-Dried Cakes (Sarah H. M. Hedberg, Sharmila Devi, Arnold Duralliu, Daryl R. Williams)....Pages 327-351 High-Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids (Karthik Balakrishna Chandrababu, Rajashekar Kammari, Yuan Chen, Elizabeth M. Topp)....Pages 353-375 Back Matter ....Pages 377-382