Mammalian Cell Cultures for Biologics Manufacturing, Weichang Zhou; Anne Kantardjieff

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

Автор: V?zquez-Nin
Название: Cell Death in Mammalian Ovary
ISBN: 9400711336 ISBN-13(EAN): 9789400711334
Издательство: Springer
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Описание: The ovary is a suitable organ for studying the processes of cell death. Cell death was first described in the rabbit ovary (Graaffian follicles), the phenomenon being called ‘chromatolysis’. To date, it is recognized that various forms of cell death (programmed cell death, apoptosis and autophagy) are essential components of ovarian development and function. Programmed cell death is responsable for the ovarian endowment of primordial follicles around birth; in the prepuberal and adult period, apoptosis is a basic mechanism by which oocytes are eliminated by cancer therapies and environmental toxicants; in the ovarian cycle, follicular atresia and luteal regression involve follicular cell apoptosis. Finally, abnormalities in cell death processes may lead to ovarian disease such as cancer and chemoresistance. In this book, after an introductory description of various forms of cell death and of the ovary development and function in mammals, the processes of cell death in ovarian somatic cells and oocytes are described at cytological, physiological and molecular levels and analyzed in the embryonic, prepuberal and adult ovary. A complex array of molecular pathways triggered by extrinsic and intrinsic signals able tor induce or suppress cell death in the same cell, according to cell type and ovary developmental stage, emerges. Physiological interactions with the axis hypothalamus-hypophysis as well as ovarian internal functional signal are also critically reviewed to explain the abortive development of follicles before the beginning of the ovarian cycle. The book conveys information useful to the updating of biologists and physicians who are interested to the ovary biology and functions. Hopefully it should provide also clues for stimulating novel experiments in the study of cell death in the mammalian ovary still at an early stage.

Автор: Wei Shou Hu; An-Ping Zeng
Название: Genomics and Systems Biology of Mammalian Cell Culture
ISBN: 3642434061 ISBN-13(EAN): 9783642434068
Издательство: Springer
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Описание: Transcriptome Analysis, by Frank Stahl, Bernd Hitzmann, Kai Mutz, Daniel Landgrebe, Miriam L bbecke, Cornelia Kasper, Johanna Walter und Thomas Scheper Transcriptome Data Analysis for Cell Culture Processes, by Marlene Castro-Melchor, Huong Le und Wei-Shou Hu Modeling Metabolic Networks for Mammalian Cell Systems: General Considerations, Modeling Strategies, and Available Tools, by Ziomara P. Gerdtzen Metabolic Flux Analysis in Systems Biology of Mammalian Cells, by Jens Niklas und Elmar Heinzle Advancing Biopharmaceutical Process Development by System-Level Data Analysis and Integration of Omics Data, by Jochen Schaub, Christoph Clemens, Hitto Kaufmann und Torsten W. Schulz Protein Glycosylation and Its Impact on Biotechnology, by Markus Berger, Matthias Kaup und V ronique Blanchard Protein Glycosylation Control in Mammalian Cell Culture: Past Precedents and Contemporary Prospects, by Patrick Hossler Modeling of Intracellular Transport and Compartmentation, by Uwe Jandt und An-Ping Zeng Genetic Aspects of Cell Line Development from a Synthetic Biology Perspective, by L. Botezatu, S. Sievers, L. Gama-Norton, R. Schucht, H. Hauser und D. Wirth.

Автор: Gerardo H. V?zquez-Nin; Mar?a Luisa Escobar; M. De
Название: Cell Death in Mammalian Ovary
ISBN: 9400793944 ISBN-13(EAN): 9789400793941
Издательство: Springer
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Описание: Following a description of various forms of cell death and of ovary development and function in mammals, cell death processes in ovarian somatic cells and oocytes are described at cytological, physiological and molecular levels, as well as at differing ages.

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.

Автор: Dushyant Varshney; Manmohan Singh
Название: Lyophilized Biologics and Vaccines
ISBN: 1493955683 ISBN-13(EAN): 9781493955688
Издательство: Springer
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Цена: 16070.00 р.
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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.

Автор: Martin J. Stoddart
Название: Mammalian Cell Viability
ISBN: 1493961535 ISBN-13(EAN): 9781493961535
Издательство: Springer
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Цена: 16769.00 р.
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Описание: This book presents methods for monolayer and suspension cells, methods for determining viability within tissue sections and 3 dimensional culture systems, and methods requiring specialized equipment, all in the popular Methods in Molecular Biology (TM) series format.

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.

Автор: Henry J. Leese; Daniel R. Brison
Название: Cell Signaling During Mammalian Early Embryo Development
ISBN: 1493948288 ISBN-13(EAN): 9781493948284
Издательство: Springer
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Цена: 16977.00 р.
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Описание: The book considers signaling events from the zygote embryo through to the blastocyst with relevant data from embryonic stem (ES) cells, including dialogue with the extracellular environment and with the maternal tract during the implantation process.

Автор: S.W. de Laat; J.G. Bluemink; C.L. Mummery
Название: Cell to Cell Signals in Mammalian Development
ISBN: 3642731449 ISBN-13(EAN): 9783642731440
Издательство: Springer
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Цена: 18167.00 р.
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Описание: Proceedings of the NATO Advanced Research Workshop on Cell to Cell Signalling in Mammalian Development Held in Les Arcs, France, from February 21-26, 1988