Good Pharmaceutical Freeze-Drying Practice

Good Pharmaceutical Freeze-Drying Practice PDF

Author: Peter Cameron

Publisher: CRC Press

Published: 1997-06-30

Total Pages: 320

ISBN-13: 1482207842

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This text is devoted to pharmaceutical freeze-drying in all its forms and in all its technological variations. Whether you freeze-dry nonsterile tablets or you lyophilize injectables, this book covers all the technological and regulatory requirements. Written by a panel of leading practitioners in the pharmaceutical industry -- production experts, regulatory inspectors, technical consultants, and equipment suppliers -- the information is relevant, usable, and timely. Practical, "how to" chapters serve as training aids, and each section stands on its own as a concise, easy-to-access resource for both managers and technicians.

Freeze-drying of Pharmaceuticals and Biopharmaceuticals

Freeze-drying of Pharmaceuticals and Biopharmaceuticals PDF

Author: Felix Franks

Publisher: Royal Society of Chemistry

Published: 2008

Total Pages: 220

ISBN-13: 0854041516

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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.

Freeze-drying/lyophilization of Pharmaceutical and Biological Products

Freeze-drying/lyophilization of Pharmaceutical and Biological Products PDF

Author: Louis Rey

Publisher: CRC Press

Published: 1999

Total Pages: 504

ISBN-13:

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Highlights the application of freeze-drying to pharmaceuticals-illustrating practical & industry-tested methods of preserving & reactivating delicate biologicals & biochemicals. Discusses the basic principles & engineering aspects of lyophilization, & also the role of bulking agents, additives, cryoprotectants, antioxidants, free radicals, & other products that protect the biological integrity of active substances during freezing, drying, & storage.

Freeze-Drying of Pharmaceutical and Food Products

Freeze-Drying of Pharmaceutical and Food Products PDF

Author: Tse-Chao Hua

Publisher: Elsevier

Published: 2010-07-30

Total Pages: 274

ISBN-13: 1845697472

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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

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

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

Author: Louis Rey

Publisher: CRC Press

Published: 2010-06-15

Total Pages: 0

ISBN-13: 9781439825754

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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.

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products PDF

Author: Davide Fissore

Publisher: CRC Press

Published: 2019-10-24

Total Pages: 201

ISBN-13: 042966401X

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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.

Principles and Practices of Lyophilization in Product Development and Manufacturing

Principles and Practices of Lyophilization in Product Development and Manufacturing PDF

Author: Feroz Jameel

Publisher: Springer Nature

Published: 2023-04-24

Total Pages: 621

ISBN-13: 3031126343

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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.

Freeze-Drying

Freeze-Drying PDF

Author: Peter Haseley

Publisher: John Wiley & Sons

Published: 2018-05-07

Total Pages: 434

ISBN-13: 3527343067

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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.

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