Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
Author: Louis Rey
Publisher:
Total Pages: 0
Release: 2024-10-14
Genre: Business & Economics
ISBN: 9781032918457

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/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded
Author: Louis Rey
Publisher: CRC Press
Total Pages: 634
Release: 2004-01-21
Genre: Medical
ISBN: 0203021320

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

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
Author: Louis Rey
Publisher: CRC Press
Total Pages: 580
Release: 2016-04-19
Genre: Medical
ISBN: 1439825769

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

Freeze-Drying

Freeze-Drying
Author: Peter Haseley
Publisher: John Wiley & Sons
Total Pages: 434
Release: 2018-05-07
Genre: Science
ISBN: 3527343067

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.

Lyophilization

Lyophilization
Author: Thomas A. Jennings
Publisher: CRC Press
Total Pages: 664
Release: 1999-08-31
Genre: Medical
ISBN: 9781574910810

Finding consistent, analytical discussions of processes and principles of lyophilization can be challenging and often frustrating. The first resource to gather information about the field, Lyophilization: Introduction and Basic Principles is still the book to have on lyophilization. Presenting information in an easy-to-read style, the book comprehensively and authoritatively covers the field. Using plain, unpretentious language, author Thomas A. Jennings pulls together information from diverse sources to provide an authoritative compendium of the lyophilization process and its basic principles. He provides important discussions about the nature of the container-closure system and the equipment, tools, and environments required. Case studies and examples of solutions illustrate the many ways problems can be addressed in the lyophilization process. The book covers: Properties of lyophilized materials Product formulation requirements and the thermal properties of formulations Importance of process water Phase changes Thermal analytical methods Freezing, primary, and secondary drying processes Effect of vacuum freeze-dryers, both now and in the future Including over 150 illustrations, global symbols, and more than 350 references, this book is the complete guide to lyophilization, its analytical methods, measurement of process parameters, and equipment.

Lyophilization of Pharmaceuticals and Biologicals

Lyophilization of Pharmaceuticals and Biologicals
Author: Kevin R. Ward
Publisher: Humana Press
Total Pages: 437
Release: 2018-12-13
Genre: Medical
ISBN: 9781493989270

This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products
Author: Davide Fissore
Publisher: CRC Press
Total Pages: 212
Release: 2019-10-24
Genre: Medical
ISBN: 042966401X

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.

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products
Author: Davide Fissore
Publisher: CRC Press
Total Pages: 211
Release: 2019-10-24
Genre: Medical
ISBN: 042966673X

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.

Rational Design of Stable Protein Formulations

Rational Design of Stable Protein Formulations
Author: John F. Carpenter
Publisher: Springer Science & Business Media
Total Pages: 218
Release: 2012-12-06
Genre: Medical
ISBN: 1461505577

Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Microencapsulation

Microencapsulation
Author: Simon Benita
Publisher: CRC Press
Total Pages: 781
Release: 2005-11-01
Genre: Medical
ISBN: 1420027999

Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and e