Freeze Drying Lyophilization Of Pharmaceutical And Biological Products PDF Download
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Author | : Louis Rey |
Publisher | : CRC Press |
Total Pages | : 580 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1439825769 |
Download Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products Book in PDF, ePub and Kindle
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 | : Louis Rey |
Publisher | : CRC Press |
Total Pages | : 634 |
Release | : 2004-01-21 |
Genre | : Medical |
ISBN | : 0203021320 |
Download Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded Book in PDF, ePub and Kindle
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 |
Total Pages | : 640 |
Release | : 2004-01-21 |
Genre | : Medical |
ISBN | : 9780824748685 |
Download Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Second Edition, Revised and Expanded Book in PDF, ePub and Kindle
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 | : Tse-Chao Hua |
Publisher | : Elsevier |
Total Pages | : 274 |
Release | : 2010-07-30 |
Genre | : Technology & Engineering |
ISBN | : 1845697472 |
Download Freeze-Drying of Pharmaceutical and Food Products Book in PDF, ePub and Kindle
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 | : Satoshi Ohtake |
Publisher | : John Wiley & Sons |
Total Pages | : 394 |
Release | : 2020-06-02 |
Genre | : Medical |
ISBN | : 3527341129 |
Download Drying Technologies for Biotechnology and Pharmaceutical Applications Book in PDF, ePub and Kindle
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.
Author | : Henry R. Costantino |
Publisher | : Springer Science & Business Media |
Total Pages | : 726 |
Release | : 2005-12-05 |
Genre | : Medical |
ISBN | : 9780971176768 |
Download Lyophilization of Biopharmaceuticals Book in PDF, ePub and Kindle
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 | : Feroz Jameel |
Publisher | : Springer Nature |
Total Pages | : 621 |
Release | : 2023-04-24 |
Genre | : Medical |
ISBN | : 3031126343 |
Download Principles and Practices of Lyophilization in Product Development and Manufacturing Book in PDF, ePub and Kindle
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 | : Davide Fissore |
Publisher | : CRC Press |
Total Pages | : 201 |
Release | : 2019-10-24 |
Genre | : Medical |
ISBN | : 042966401X |
Download Freeze Drying of Pharmaceutical Products Book in PDF, ePub and Kindle
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 |
Total Pages | : 220 |
Release | : 2008 |
Genre | : Medical |
ISBN | : 0854041516 |
Download Freeze-drying of Pharmaceuticals and Biopharmaceuticals Book in PDF, ePub and Kindle
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 | : Kevin R. Ward |
Publisher | : Humana Press |
Total Pages | : 437 |
Release | : 2018-12-13 |
Genre | : Medical |
ISBN | : 9781493989270 |
Download Lyophilization of Pharmaceuticals and Biologicals Book in PDF, ePub and Kindle
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.