Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Second Edition: Revised And Expanded (Drugs and the Pharmaceutical Sciences)

Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products. Containing more than 1,000 figures, tables, and references, and 13 new chapters, this text thoroughly acquaints the reader with freeze-drying fundamentals, including water properties critical to the process and mechanisms and means of protein stability. It also unveils innovations including Lyoguard( packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products. In their 1906 paper to the Academie des Sciences in Paris (almost a century ago), Bordas and d'Arsonval [1] demonstrated for the first time that it was possible to dry a delicate product from the frozen state under moderate vacuum.