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Lyophilization
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Book Synopsis Lyophilization of Pharmaceuticals and Biologicals by : Kevin R. Ward
Download or read book Lyophilization of Pharmaceuticals and Biologicals written by Kevin R. Ward and published by Humana Press. This book was released on 2018-12-13 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :Henry R. Costantino Publisher :Springer Science & Business Media ISBN 13 :9780971176768 Total Pages :726 pages Book Rating :4.1/5 (767 download)
Book Synopsis Lyophilization of Biopharmaceuticals by : Henry R. Costantino
Download or read book Lyophilization of Biopharmaceuticals written by Henry R. Costantino and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 726 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Lyophilization by : Thomas A. Jennings
Download or read book Lyophilization written by Thomas A. Jennings and published by CRC Press. This book was released on 1999-08-31 with total page 664 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Principles and Practices of Lyophilization in Product Development and Manufacturing by : Feroz Jameel
Download or read book Principles and Practices of Lyophilization in Product Development and Manufacturing written by Feroz Jameel and published by Springer Nature. This book was released on 2023-04-24 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by : Louis Rey
Download or read book Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded written by Louis Rey and published by CRC Press. This book was released on 2004-01-21 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Lyophilized Biologics and Vaccines by : Dushyant Varshney
Download or read book Lyophilized Biologics and Vaccines written by Dushyant Varshney and published by Springer. This book was released on 2015-05-19 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Freeze Drying of Pharmaceutical Products by : Davide Fissore
Download or read book Freeze Drying of Pharmaceutical Products written by Davide Fissore and published by CRC Press. This book was released on 2019-10-24 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Drying Technologies for Biotechnology and Pharmaceutical Applications by : Satoshi Ohtake
Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Handbook of Downstream Processing by : E. Goldberg
Download or read book Handbook of Downstream Processing written by E. Goldberg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 745 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?
Book Synopsis Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products by : Louis Rey
Download or read book Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products written by Louis Rey and published by CRC Press. This book was released on 2016-04-19 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Protein Formulation and Delivery by : Eugene J. McNally
Download or read book Protein Formulation and Delivery written by Eugene J. McNally and published by CRC Press. This book was released on 2007-10-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica
Download or read book Platelets written by Alan D. Michelson and published by Elsevier. This book was released on 2011-08-29 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Platelets, Second Edition is the definitive current source of state-of-the-art knowledge about platelets and covers the entire field of platelet biology, pathophysiology, and clinical medicine. Recently there has been a rapid expansion of knowledge in both basic biology and the clinical approach to platelet-related diseases including thrombosis and hemorrhage. Novel platelet function tests, drugs, blood bank storage methods, and gene therapies have been incorporated into patient care or are in development. This book draws all this information into a single, comprehensive and authoritative resource. - First edition won Best Book in Medical Science Award from the Association of American Publishers - Contains fourteen new chapters on topics such as platelet genomics and proteomics, inhibition of platelet function by the endothelium, clinical tests of platelet function, real time in vivo imaging of platelets, and inherited thrombocytopenias - A comprehensive full color reference comprising over 70 chapters, 1400 pages, and 16,000 references
Download or read book Freeze-Drying written by Peter Haseley and published by John Wiley & Sons. This book was released on 2018-05-07 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Rational Design of Stable Protein Formulations by : John F. Carpenter
Download or read book Rational Design of Stable Protein Formulations written by John F. Carpenter and published by Springer Science & Business Media. This book was released on 2002-04-30 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Validation of Pharmaceutical Processes by : James P. Agalloco
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Book Synopsis Vaccine Development and Manufacturing by : Emily P. Wen
Download or read book Vaccine Development and Manufacturing written by Emily P. Wen and published by John Wiley & Sons. This book was released on 2014-10-06 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market
Book Synopsis Biodiversity of Fungi by : Mercedes S. Foster
Download or read book Biodiversity of Fungi written by Mercedes S. Foster and published by Elsevier. This book was released on 2011-04-28 with total page 797 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biodiversity of Fungi is essential for anyone collecting and/or monitoring any fungi. Fascinating and beautiful, fungi are vital components of nearly all ecosystems and impact human health and our economy in a myriad of ways. Standardized methods for documenting diversity and distribution have been lacking. A wealth of information, especially regrading sampling protocols, compiled by an international team of fungal biologists, make Biodiversity of Fungi an incredible and fundamental resource for the study of organismal biodiversity. Chapters cover everything from what is a fungus, to maintaining and organizing a permanent study collection with associated databases; from protocols for sampling slime molds to insect associated fungi; from fungi growing on and in animals and plants to mushrooms and truffles. The chapters are arranged both ecologically and by sampling method rather than by taxonomic group for ease of use. The information presented here is intended for everyone interested in fungi, anyone who needs tools to study them in nature including naturalists, land managers, ecologists, mycologists, and even citizen scientists and sophiscated amateurs. - Covers all groups of fungi - from molds to mushrooms, even slime molds - Describes sampling protocols for many groups of fungi - Arranged by sampling method and ecology to coincide with users needs - Beautifully illustrated to document the range of fungi treated and techniques discussed - Natural history data are provided for each group of fungi to enable users to modify suggested protocols to meet their needs
