Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded PDF full book. Access full book title Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by Louis Rey. Download full books in PDF and EPUB format.
Author: Louis Rey
Publisher: CRC Press
ISBN: 0203021320
Category : Medical
Languages : en
Pages : 634
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: CRC Press
ISBN: 0203021320
Category : Medical
Languages : en
Pages : 634
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: 9780824748685
Category : Biological products
Languages : en
Pages : 613
Get Book Here
Book Description
Author: Louis Rey
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 613
Get Book Here
Book Description
Author: Louis Rey
Publisher: CRC Press
ISBN: 9781439825754
Category : Medical
Languages : en
Pages : 0
Get Book Here
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
Get Book Here
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: Peter Haseley
Publisher: John Wiley & Sons
ISBN: 3527343067
Category : Science
Languages : en
Pages : 434
Get Book Here
Book Description
This completely updated and enlarged third edition of the classic text adopts a practical approach to describe the fundamentals of freeze-drying, backed by many explanatory examples. Following an introduction to the fundamentals, the book goes on to discuss process and plant automation as well as methods to transfer pilot plant qualifications and process data to production. An entire section is devoted to a large range of different pharmaceutical, biological, and medical products. New to this edition are chapters on antibodies, freeze-dry microscopy, TEMPRIS, microwave freeze-drying, spray freeze-drying, and PAT. Their many years of experience in freeze-drying enable the authors to supply valuable criteria for the selection of laboratory, pilot and production plants, discussing the advantages, drawbacks and limitations of different plant designs. Alongside guidelines for the evaluation and qualification of plants and processes, the author also includes a troubleshooting section.
Author: Tse-Chao Hua
Publisher: Elsevier
ISBN: 1845697472
Category : Technology & Engineering
Languages : en
Pages : 274
Get Book Here
Book Description
Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area. The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation. Freeze-drying of pharmaceutical and food products is an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields. Addresses the principles and practices used in this important preservation technique Explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used Discusses the importance of disinfection, sterilization and process validation
Author: Henry R. Costantino
Publisher: Springer Science & Business Media
ISBN: 9780971176768
Category : Medical
Languages : en
Pages : 726
Get Book Here
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
Get Book Here
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: Felix Franks
Publisher: Royal Society of Chemistry
ISBN: 0854041516
Category : Medical
Languages : en
Pages : 220
Get Book Here
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.
