vaccine development and manufacturing wiley series in biotechnology and bioengineering

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Vaccine Development And Manufacturing

Author : Emily P. Wen
ISBN : 9781118870907
Genre : Technology & Engineering
File Size : 75. 11 MB
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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

Current Developments In Biotechnology And Bioengineering

Author : Vanete Thomaz Soccol
ISBN : 9780444636713
Genre : Science
File Size : 88. 21 MB
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Current Developments in Biotechnology and Bioengineering: Human and Animal Health Applications provides extensive coverage of new developments, state-of-the-art technologies, and potential future trends, presenting data-based scientific knowledge and information on medical biotechnological interventions for human and animal health. Drawing on the key development areas in this field, the book reviews biotechnological advances and applications in immunotechnology, vaccines and vaccinology, combinatorial libraries, gene and cell therapy, tissue engineering, and parasite and infectious disease diagnostics. This title outlines why biotechnological techniques in these areas are useful in a clinical context and considers their potential uses, limitations, and the ethical considerations surrounding their use. Provides development in human and animal health due to biotechnology Includes immunotechnology and vaccinology Outlines diagnostic techniques based on tissue and metabolic engineering principles Considers potential uses of the various biotechnology based techniques and the ethical issues raised in their use

Preparative Chromatography For Separation Of Proteins

Author : Arne Staby
ISBN : 9781119031109
Genre : Science
File Size : 62. 50 MB
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"Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals"--

Continuous Processing In Pharmaceutical Manufacturing

Author : Ganapathy Subramanian
ISBN : 9783527673704
Genre : Medical
File Size : 77. 64 MB
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With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Quality By Design For Biopharmaceuticals

Author : Anurag S. Rathore
ISBN : 9781118210918
Genre : Science
File Size : 65. 24 MB
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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Biological Drug Products

Author : Wei Wang
ISBN : 9781118695227
Genre : Medical
File Size : 29. 40 MB
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Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

Fundamentals Of Food Biotechnology

Author : Byong H. Lee
ISBN : 9781118384916
Genre : Science
File Size : 67. 33 MB
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Food biotechnology is the application of modern biotechnological techniques to the manufacture and processing of food, for example through fermentation of food (which is the oldest biotechnological process) and food additives, as well as plant and animal cell cultures. New developments in fermentation and enzyme technological processes, molecular thermodynamics, genetic engineering, protein engineering, metabolic engineering, bioengineering, and processes involving monoclonal antibodies, nanobiotechnology and quorum sensing have introduced exciting new dimensions to food biotechnology, a burgeoning field that transcends many scientific disciplines. Fundamentals of Food Biotechnology, 2nd edition is based on the author’s 25 years of experience teaching on a food biotechnology course at McGill University in Canada. The book will appeal to professional food scientists as well as graduate and advanced undergraduate students by addressing the latest exciting food biotechnology research in areas such as genetically modified foods (GMOs), bioenergy, bioplastics, functional foods/nutraceuticals, nanobiotechnology, quorum sensing and quenching. In addition, cloning techniques for bacterial and yeast enzymes are included in a “New Trends and Tools” section and selected references, questions and answers appear at the end of each chapter. This new edition has been comprehensively rewritten and restructured to reflect the new technologies, products and trends that have emerged since the original book. Many new aspects highlight the short and longer term commercial potential of food biotechnology.

Nucleic Acids

Author : Botho Bowien
ISBN : 1588830187
Genre : Computers
File Size : 80. 52 MB
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Nucleic Acids Isolation Methods is part of a book series entitled Genome Science and Nucleic Acids. The volume Nucleic Acids Isolation Methods is devoted to preparation of genomic DNA, plasmid DNA, viral nucleic acids, and RNA. Emphasis is also put on stabilization of nucleic acids prior to isolation, scale-up of plasmid isolation, and DNA cleanup from gels, PCR, sequencing, etc. A number of specific medical and forensic applications are detailed such as preparation of pathogen nucleic acids for real-time PCR analysis, extraction of DNA from paraffin embedded bone marrow trephine biopsies, and isolation of nucleic acids from tissue, blood, semen, hair, and saliva for DNA fingerprints, RELP, and PCR analyses. This book contains 10 state-of-the-art review chapters written by 20 renowned experts from leading research institutions, industry and a criminal investigation department. Detailed description of methods as well as their theoretical background makes this volume an essential reference for specialists in academia, research institutions, and industry and also a valuable manual for newcomers to this field.

Engineering Conference Index

Author :
ISBN : 0873940415
Genre : Engineering
File Size : 34. 77 MB
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G Rungschemisches Praktikum

Author : Konrad Bernhauer
ISBN : 9783642913921
Genre : Science
File Size : 43. 18 MB
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Dieser Buchtitel ist Teil des Digitalisierungsprojekts Springer Book Archives mit Publikationen, die seit den Anfängen des Verlags von 1842 erschienen sind. Der Verlag stellt mit diesem Archiv Quellen für die historische wie auch die disziplingeschichtliche Forschung zur Verfügung, die jeweils im historischen Kontext betrachtet werden müssen. Dieser Titel erschien in der Zeit vor 1945 und wird daher in seiner zeittypischen politisch-ideologischen Ausrichtung vom Verlag nicht beworben.

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