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Freeze-drying/lyophilization of Pharmaceutical and Biological Products

Author: Louis Rey

Publisher: CRC Press

Published: 1999

Total Pages: 504

ISBN-13:

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/Lyophilization of Pharmaceutical and Biological Products, Third Edition

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.

Lyophilization of Pharmaceuticals and Biologicals

Author: Kevin R. Ward

Publisher: Humana Press

Published: 2018-12-13

Total Pages: 437

ISBN-13: 9781493989270

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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/lyophilization of Pharmaceutical and Biological Products

Author: Louis Rey

Publisher:

Published: 2004

Total Pages: 613

ISBN-13: 9780824748685

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Lyophilization of Biopharmaceuticals

Author: Henry R. Costantino

Publisher: Springer Science & Business Media

Published: 2005-12-05

Total Pages: 726

ISBN-13: 9780971176768

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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.

Principles and Practices of Lyophilization in Product Development and Manufacturing

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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Author: Satoshi Ohtake

Publisher: John Wiley & Sons

Published: 2020-06-02

Total Pages: 394

ISBN-13: 3527341129

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A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Freeze-drying of Pharmaceuticals and Biopharmaceuticals

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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Author: Satoshi Ohtake

Publisher: John Wiley & Sons

Published: 2020-02-03

Total Pages: 400

ISBN-13: 3527802096

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

Author: Louis Rey

Publisher: CRC Press

Published: 2004-01-21

Total Pages: 634

ISBN-13: 0203021320

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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.