Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Second Edition, Revised and Expanded PDF Download
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Author: Louis Rey
Publisher: CRC Press
ISBN: 9780824748685
Category : Medical
Languages : en
Pages : 640
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Book Description
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.
Author: Louis Rey
Publisher: CRC Press
ISBN: 0203021320
Category : Medical
Languages : en
Pages : 634
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Book Description
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.
Author: Louis Rey
Publisher: CRC Press
ISBN: 9780824748685
Category : Medical
Languages : en
Pages : 640
Get Book Here
Book Description
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.
Author: Louis Rey
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 613
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Book Description
Author: Louis Rey
Publisher: CRC Press
ISBN: 9781439825754
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Feroz Jameel
Publisher: Springer Nature
ISBN: 3031126343
Category : Medical
Languages : en
Pages : 621
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Book Description
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.
Author: Henry R. Costantino
Publisher: Springer Science & Business Media
ISBN: 9780971176768
Category : Medical
Languages : en
Pages : 726
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Book Description
Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.
Author: Davide Fissore
Publisher: CRC Press
ISBN: 042966673X
Category : Medical
Languages : en
Pages : 211
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Book Description
Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.
Author: Louis Rey
Publisher: CRC Press
ISBN: 1439825769
Category : Medical
Languages : en
Pages : 580
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Book Description
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 regulatio
Author: Felix Franks
Publisher: Royal Society of Chemistry
ISBN: 0854041516
Category : Medical
Languages : en
Pages : 220
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Book Description
Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.
Author: Georg-Wilhelm Oetjen
Publisher: John Wiley & Sons
ISBN: 9783527306206
Category : Science
Languages : en
Pages : 412
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Book Description
Table of Contents Preface Preface to the First Edition 1 Foundations and Process Engineering 1 2 Installation and Equipment Technique 165 3 Pharmaceutical, Biological and Medical Products 295 4 Food and Luxury Food 345 5 Metal Oxides, Ceramic Powders 359 6 Trouble Shooting and Regulatory Issues 367.
