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Lyophilized Biologics and Vaccines, Dushyant Varshney; Manmohan Singh


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Автор: Dushyant Varshney; Manmohan Singh
Название:  Lyophilized Biologics and Vaccines
ISBN: 9781493955688
Издательство: Springer
Классификация:


ISBN-10: 1493955683
Обложка/Формат: Paperback
Страницы: 401
Вес: 0.58 кг.
Дата издания: 09.10.2016
Язык: English
Издание: Softcover reprint of
Иллюстрации: 39 tables, black and white; 68 illustrations, color; 31 illustrations, black and white; xi, 401 p. 99 illus., 68 illus. in color.
Размер: 234 x 156 x 22
Читательская аудитория: Professional & vocational
Основная тема: Biomedicine
Подзаголовок: Modality-Based Approaches
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: 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.
Дополнительное описание: Preface.- Part I – Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instru



Pharmaco-Imaging in Drug and Biologics Development

Автор: Brian R. Moyer; Narayan P.S. Cheruvu; Tom C.-C. Hu
Название: Pharmaco-Imaging in Drug and Biologics Development
ISBN: 1461482461 ISBN-13(EAN): 9781461482468
Издательство: Springer
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Цена: 23757.00 р.
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Описание: The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape.

Psychiatry and Biological Factors

Автор: Edouard Kurstak
Название: Psychiatry and Biological Factors
ISBN: 1468458132 ISBN-13(EAN): 9781468458138
Издательство: Springer
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Цена: 6986.00 р.
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Описание: The main purpose of the volume Psychiatry and Biological Factors is to provide a comprehensive, state-of-the-art overview of the current research linked essentially to virus infections, immunity functions, and mental diseases.

Biological Response Modifiers — Interferons, Double-Stranded RNA and 2?,5?-Oligoadenylates

Автор: W.E.G. M?ller; H.C. Schr?der
Название: Biological Response Modifiers — Interferons, Double-Stranded RNA and 2?,5?-Oligoadenylates
ISBN: 3642785514 ISBN-13(EAN): 9783642785511
Издательство: Springer
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Цена: 18167.00 р.
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Описание: Biological response modifiers are increasingly used in viral and cancer therapy. Since alterations of the immune system are the primary symptoms of HIV infection, especially therapies directed towards the modulation of the immune response have been under intense evaluation.

Lyophilized Biologics and Vaccines

Автор: Dushyant Varshney; Manmohan Singh
Название: Lyophilized Biologics and Vaccines
ISBN: 149392382X ISBN-13(EAN): 9781493923823
Издательство: Springer
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Цена: 22359.00 р.
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Описание:

Preface.- Part I - Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles.- New Developments in Controlled Nucleation: Commercializing VERISEQ(R) Nucleation technology.- Part II - Lyophilized Biologics and Vaccines - Modality Considerations.- Lyophilized Biologics.- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design.- Advances in Process Analytical Technology in Freeze Drying.- Process Scale-up and Optimization of Lyophilized Vaccine Products.- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations.- Part III - Advances in Alternate Drying.- Alternatives to Vial Lyophilization.- Spray Drying of Biopharmaceuticals.- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals.- Case Studies and Examples of Biopharmaceutical Modalities.- Processed by Bulk Crystallization or Bulk Freeze Drying.- Part IV- Regulatory, Packaging and Technology Transfer Considerations.- Lyophilization of Biologics - An FDA Perspective.- Recent Trends in Lyophilized Delivery Devices and Packaging.- Lyophilization Technology Transfer towards Product Launch.

Safety of Biologics Therapy

Автор: Baldo
Название: Safety of Biologics Therapy
ISBN: 3319304704 ISBN-13(EAN): 9783319304700
Издательство: Springer
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Цена: 22359.00 р.
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Описание: This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

Biologics in General Medicine

Автор: W.-H. Boehncke; H.H. Radeke
Название: Biologics in General Medicine
ISBN: 364243567X ISBN-13(EAN): 9783642435676
Издательство: Springer
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Цена: 23757.00 р.
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Описание: The idea for this book was born during the symposium on biologics organized by ZAFES (Center for Drug Research, Development and Safety at the University of Frankfurt am Main) in September 2005. Highly distinguished researchers special- ing in the field of biologics had gathered together to exchange information on this relatively new subject. Realizing that this symposium was one of the few sources of condensed information on biologics, it became obvious that we had to create a means of informing an interested wider circle of scientists and especially general c- nicians. Therefore, the editors of this book suggested to the researchers at the symposium andalsotoprominent scientists andcliniciansinvolvedinthe developmentand application of biologics as their major field of interest the idea of assembling this compendium. We received an overwhelmingly positive response – thankfully also from the publisher – most being more than willing to support this innovative project with highly relevant chapters on the latest state of the art. As we were eager to fill the information gap with up-to-date knowledge, the project had to be finished within the shortest time possible. To all experienced with editing this was obviously a ch- lengeand we areverythankfultoall thecontributorsthatour timeline hadtobe extended by only a few months. This book represents a collection of the most recent knowledge on biologics written by people who have been active in the field for many years. Wolf-Henning Boehncke Heinfried H. Radeke Contents 1 Introduction: Definition and Classification of Biologics W. -H. Boehncke, H. H. Radeke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vaccines

Автор: Peter Perlman; Hans Wigzell
Название: Vaccines
ISBN: 3642641962 ISBN-13(EAN): 9783642641961
Издательство: Springer
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Цена: 18167.00 р.
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Описание: With contributions by numerous experts

Biological Modulation of Solid Tumours by Interferons

Автор: Karl Pummer
Название: Biological Modulation of Solid Tumours by Interferons
ISBN: 3642788688 ISBN-13(EAN): 9783642788680
Издательство: Springer
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Цена: 18167.00 р.
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Описание: For this purpose, after two chapters of general aspects of interferon action and interaction, selected solid tumours which are commonly considered difficult to treat in advanced stages are discussed with respect to both preclinical data and clinical experience.

Mammalian Cell Cultures for Biologics Manufacturing

Автор: Weichang Zhou; Anne Kantardjieff
Название: Mammalian Cell Cultures for Biologics Manufacturing
ISBN: 364254049X ISBN-13(EAN): 9783642540493
Издательство: Springer
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Цена: 39130.00 р.
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Описание: Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification.

Mammalian Cell Cultures for Biologics Manufacturing

Автор: Weichang Zhou; Anne Kantardjieff
Название: Mammalian Cell Cultures for Biologics Manufacturing
ISBN: 3662522705 ISBN-13(EAN): 9783662522707
Издательство: Springer
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Цена: 48913.00 р.
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Описание: Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Vaccines and Autoimmunity

Автор: Yehuda Shoenfeld,Nancy Agmon–Levin
Название: Vaccines and Autoimmunity
ISBN: 1118663438 ISBN-13(EAN): 9781118663431
Издательство: Wiley
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Цена: 22485.00 р.
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Описание: In light of the discovery of Autoimmune Syndrome Induced by Adjuvants, or ASIA, Vaccines and Autoimmunity explores the role of adjuvants specifically aluminum in different vaccines and how they can induce diverse autoimmune clinical manifestations in genetically prone individuals.

Defense of Mucosal Surfaces: Pathogenesis, Immunity and Vaccines

Автор: Jean-Pierre Kraehenbuhl; Marian R. Neutra
Название: Defense of Mucosal Surfaces: Pathogenesis, Immunity and Vaccines
ISBN: 3642641946 ISBN-13(EAN): 9783642641947
Издательство: Springer
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Цена: 18167.00 р.
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Описание: Mucosal immunity encompasses a broad field of research that includes areas of epithelial cell and molecular biology, molecular and cellular immunology, microbiology, virology, and vaccinology. It provides an overview of the components of the mucosal immune system, and the basic science relevant to mucosal vaccination.


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