Publication Date: 2005-12-05
Edited by Henry R. Costantino and Michael J. Pikal
Volume 2 of the AAPS Press series, Biotechnology: Pharmaceutical Aspects. This edition covers the important topic of freeze-drying of biopharmaceuticals. The book starts by discussing lyophilization equipment and validation. Next, stresses involved in lyophilization are reviewed. Other important areas included in this volume are transport phenomena, physics of glassy materials, and process design and control. Formulation development and lyophilization cycle development are likewise reviewed. Also included is a relevant and comprehensive presentation of FDA-approved biopharmaceutical products and their excipients. Attention is given to the characterization of protein and peptide powders by commonly used solid-state methods. These methods facilitate formulation development in a rational fashion to address the various solid-state degradation mechanisms, which are also reviewed in a separate chapter. Additional chapters which should provide timely relevant reviews treat lyophilization of liposomes, lyophilization of nucleic acids, spray freeze drying, and the use of dried enzymes as non-aqueous catalysts. See also the table of contents.
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