International Symposium on Freeze-drying of Biological Products PDF Download

Author: International Association of Biological Standardization
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 416

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Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1732

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First multi-year cumulation covers six years: 1965-70.

Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1256

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Book Description
First multi-year cumulation covers six years: 1965-70.

Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527802118
Category : Medical
Languages : en
Pages : 366

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Book Description
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
ISBN: 9780971176768
Category : Medical
Languages : en
Pages : 726

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Book Description
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: Dushyant Varshney
Publisher: Springer
ISBN: 1493923838
Category : Medical
Languages : en
Pages : 399

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Book Description
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.

Author: John G. Day
Publisher: Springer Science & Business Media
ISBN: 1588293777
Category : Science
Languages : en
Pages : 703

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Book Description
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.

Author: Louis Rey
Publisher: CRC Press
ISBN: 0203021320
Category : Medical
Languages : en
Pages : 634

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Book Description
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: Davide Fissore
Publisher: CRC Press
ISBN: 042966401X
Category : Medical
Languages : en
Pages : 212

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Book Description
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: M.P. Starr
Publisher: Springer Science & Business Media
ISBN: 3662131870
Category : Science
Languages : en
Pages : 1276

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Book Description
The purpose ofthis brief Foreword is to make you, the reader, hungry for the scientific feast that follows. These two volumes on the prokary otes offer a truly unique scientific menu-a comprehensive assembly of articles, exhibiting the biochemical depth and remarkable physiological and morphological diversity of prokaryote life. The size of the volumes might initially discourage the unprepared mind from being attracted to the study of prokaryote life, for this landmark assemblage thoroughly documents the wealth of present knowledge. But in confronting the reader with the state of the art, the Handbook also defines where new work needs to be done on well-studied bacteria as well as on unusual or poorly studied organisms. There are basically two ways of doing research with microbes. A classical approach is first to define the phenomenon to be studied and then to select the organism accordingly. Another way is to choose a specific organism and go where it leads. The pursuit of an unusual microbe brings out the latent hunter in all of us. The intellectual chal lenges of the chase frequently test our ingenuity to the limit. Sometimes the quarry repeatedly escapes, but the final capture is indeed a wonder ful experience. For many of us, these simple rewards are sufficiently gratifying so that we have chosen to spend our scientific lives studying these unusual creatures.