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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
  • Author : Louis Rey
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :584
  • ISBN : 9781439825761
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Summary : 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/Lyophilization Of Pharmaceutical & Biological Products, Second Edition, Revised and Expanded

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Second Edition, Revised and Expanded
  • Author : Louis Rey,Joan C. May
  • Publisher :Unknown
  • Release Date :2004-01-21
  • Total pages :600
  • ISBN : 9780203021323
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Summary : 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 & Biological Products, Second Edition, Revised and Expanded

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Second Edition, Revised and Expanded
  • Author : Louis Rey,Joan C. May
  • Publisher :Unknown
  • Release Date :2004-01-21
  • Total pages :640
  • ISBN : 0824748689
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Summary : 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, Third Edition

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition
  • Author : Louis Rey,Joan C. May
  • Publisher :Unknown
  • Release Date :2010-06-15
  • Total pages :578
  • ISBN : 1439825750
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Summary : 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
  • Author : Davide Fissore,Roberto Pisano,Antonello Barresi
  • Publisher :Unknown
  • Release Date :2019-10-24
  • Total pages :192
  • ISBN : 9780429664014
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Summary : 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.

Lyophilization of Pharmaceuticals and Biologicals

Lyophilization of Pharmaceuticals and Biologicals
  • Author : Kevin R. Ward,Paul Matejtschuk
  • Publisher :Unknown
  • Release Date :2018-12-13
  • Total pages :437
  • ISBN : 1493989278
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Summary : 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.

Lyophilization of Biopharmaceuticals

Lyophilization of Biopharmaceuticals
  • Author : Henry R. Costantino,Michael J. Pikal
  • Publisher :Unknown
  • Release Date :2004
  • Total pages :686
  • ISBN : 0971176760
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Summary : 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.

Freeze-Drying of Pharmaceutical and Food Products

Freeze-Drying of Pharmaceutical and Food Products
  • Author : Tse-Chao Hua,Bao-Lin Liu,Haimei Zhang
  • Publisher :Unknown
  • Release Date :2010-07-30
  • Total pages :280
  • ISBN : 9781845697471
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Summary : 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

Good Pharmaceutical Freeze-Drying Practice

Good Pharmaceutical Freeze-Drying Practice
  • Author : Peter Cameron
  • Publisher :Unknown
  • Release Date :1997-06-30
  • Total pages :320
  • ISBN : 9781482207842
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Summary : 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
  • Author : Felix Franks,Tony Auffret
  • Publisher :Unknown
  • Release Date :2008
  • Total pages :206
  • ISBN : 9780854041510
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Summary : 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.

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
  • Author : Dushyant Varshney,Manmohan Singh
  • Publisher :Unknown
  • Release Date :2015-05-19
  • Total pages :401
  • ISBN : 9781493923830
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Summary : This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products
  • Author : Davide Fissore,Roberto Pisano,Antonello Barresi
  • Publisher :Unknown
  • Release Date :2019-10-24
  • Total pages :192
  • ISBN : 9780429664014
GET BOOK HERE

Summary : 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.

Cryopreservation and Freeze-Drying Protocols

Cryopreservation and Freeze-Drying Protocols
  • Author : John G. Day,Glyn Stacey
  • Publisher :Unknown
  • Release Date :2007-06-05
  • Total pages :347
  • ISBN : 9781588293770
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Summary : In addition to outlining the fundamental principles associated with the conservation of biological resources, freeze-drying and cryopreservation, this text is a compilation of cryptopreservation and freeze-drying methodologies applicable to different biological materiels, developed by expert laboratories.

Freeze-Drying

Freeze-Drying
  • Author : Georg-Wilhelm Oetjen,Peter Haseley
  • Publisher :Unknown
  • Release Date :2008-01-08
  • Total pages :407
  • ISBN : 9783527612499
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Summary : Many modern pharmaceutical and biological products, e.g. blood derivatives, vaccines, cytostatic drugs, antibiotics, bacteria cultures but also consumer goods such as soluble coffee are freeze-dried to transform perishable substances into a form that can be stored and reconstituted to their almost original state without loss of quality. The book describes the up-to-date fundamentals of freeze-drying, not just presenting the process in all its seven steps theoretically, but explaining it with many practical examples. Many years of experience in freeze-drying allow 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. In this second, completely revised edition, process and plant automation are introduced in a separate section and methods to transfer pilot plant qualifications and process data to production are presented. The guidelines for process and plant evaluation and qualifications have been updated and enlarged. Trouble shooting is concentrated in a section of its own and literature has been updated with 100 new quotations to include references as recent as 2002, and 100 new tables and figures have been added.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications
  • Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
  • Publisher :Unknown
  • Release Date :2020-02-03
  • Total pages :400
  • ISBN : 9783527802098
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Summary : 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.

Advances in Food and Nutrition Research

Advances in Food and Nutrition Research
  • Author : Fidel Toldra
  • Publisher :Unknown
  • Release Date :2020-07-23
  • Total pages :344
  • ISBN : 9780128206898
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Summary : Advances in Food and Nutrition Research, Volume 93, provides information on nutrients in foods and how to avoid their deficiency, especially for those essential nutrients that should be present in the diet. Specific topics covered in this new release include drying, a relevant unit operation in the manufacture of foods and nutritional products, polycyclic aromatic hydrocarbons in edible oils and fatty foods, including occurrence, formation, analysis, change, and control, food allergens and their characterization, molecular properties and clinical implications, the design, quality, safety and efficacy of extensively hydrolyzed formula for the management of cow’s milk protein allergy, and much more. The series provides the latest advances on the identification and characterization of emerging bioactive compounds with putative health benefits, as well as up-to-date information on food science, including raw materials, production, processing, distribution and consumption. Contains contributions that have been carefully selected based on their vast experience and expertise on the subject Includes updated, in-depth and critical discussions of available information, giving the reader a unique opportunity to learn Encompasses a broad view of the topics at hand

Freeze-Drying

Freeze-Drying
  • Author : Peter Haseley,Georg-Wilhelm Oetjen
  • Publisher :Unknown
  • Release Date :2018-05-07
  • Total pages :440
  • ISBN : 9783527343065
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Summary : 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.

Rational Design of Stable Protein Formulations

Rational Design of Stable Protein Formulations
  • Author : John F. Carpenter,Mark C. Manning
  • Publisher :Unknown
  • Release Date :2012-12-06
  • Total pages :206
  • ISBN : 9781461505570
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Summary : 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.

Sustainable Drying Technologies

Sustainable Drying Technologies
  • Author : Jorge Del Real Olvera
  • Publisher :Unknown
  • Release Date :2016-08-31
  • Total pages :104
  • ISBN : 9789535125662
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Summary :

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • Author : Tapan K. Das
  • Publisher :Unknown
  • Release Date :2014-02-27
  • Total pages :376
  • ISBN : 9781118354681
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Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Water Properties of Food, Pharmaceutical, and Biological Materials

Water Properties of Food, Pharmaceutical, and Biological Materials
  • Author : Maria del Pilar Buera,Jorge Welti-Chanes,Peter J. Lillford,Horacio R. Corti
  • Publisher :Unknown
  • Release Date :2006-01-13
  • Total pages :792
  • ISBN : 9781420001181
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Summary : Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9th International Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004. Each chapter presents an authoritative account of the latest research on the physical and chemical properties of water in relation to the stability of food, pharmaceutical, and biological materials. The first part of the text focuses on presentations given by invited speakers, whereas the second part is dedicated to oral presentations and discussions. Topics include the role of water in structural and functional properties, preserving biomolecule functionality in restricted water environments, and micro- and nano- techniques used for assessing water-solid interactions in food and drug development. This book is an invaluable resource that synthesizes cutting-edge information with innovative viewpoints from internationally esteemed researchers who participated in ISOPOW 2004.