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Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded

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Release : 2004-01-21
Genre : Medical
Kind : eBook
Book Rating : 320/5 ( reviews)

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Book Synopsis Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by : Louis Rey

Download or read book Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded written by Louis Rey. This book was released on 2004-01-21. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Freeze-drying/lyophilization of Pharmaceutical and Biological Products

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Author :
Release : 2004
Genre : Biological products
Kind : eBook
Book Rating : 685/5 ( reviews)

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Book Synopsis Freeze-drying/lyophilization of Pharmaceutical and Biological Products by : Louis Rey

Download or read book Freeze-drying/lyophilization of Pharmaceutical and Biological Products written by Louis Rey. This book was released on 2004. Available in PDF, EPUB and Kindle. Book excerpt:

Freeze-drying/lyophilization of Pharmaceutical and Biological Products

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Author :
Release : 2007
Genre : Biological products
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Freeze-drying/lyophilization of Pharmaceutical and Biological Products by : Louis Rey

Download or read book Freeze-drying/lyophilization of Pharmaceutical and Biological Products written by Louis Rey. This book was released on 2007. Available in PDF, EPUB and Kindle. Book excerpt:

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition

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Author :
Release : 2010-06-15
Genre : Medical
Kind : eBook
Book Rating : 754/5 ( reviews)

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Book Synopsis Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition by : Louis Rey

Download or read book Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition written by Louis Rey. This book was released on 2010-06-15. Available in PDF, EPUB and Kindle. Book excerpt: Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This volume addresses these changes with revised chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze-drying technology.

Principles and Practices of Lyophilization in Product Development and Manufacturing

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Author :
Release : 2023-04-24
Genre : Medical
Kind : eBook
Book Rating : 343/5 ( reviews)

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Book Synopsis Principles and Practices of Lyophilization in Product Development and Manufacturing by : Feroz Jameel

Download or read book Principles and Practices of Lyophilization in Product Development and Manufacturing written by Feroz Jameel. This book was released on 2023-04-24. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on “Preservation of Biologicals” comprised of nine chapters written by experts and including case studies.

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