Vaccine Development And Manufacturing

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Vaccine Development and Manufacturing

Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Vaccine Development and Manufacturing Book PDF

Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher : John Wiley & Sons
Page : 456 pages
File Size : 50,8 Mb
Release : 2014-10-06
Category : Technology & Engineering
ISBN : 9781118870907

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Vaccine Development and Manufacturing by Emily P. Wen,Ronald Ellis,Narahari S. Pujar Pdf

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

Vaccine Development and Manufacturing

Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Vaccine Development and Manufacturing Book PDF

Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher : John Wiley & Sons
Page : 452 pages
File Size : 49,7 Mb
Release : 2014-11-17
Category : Technology & Engineering
ISBN : 9780470261941

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Vaccine Development and Manufacturing by Emily P. Wen,Ronald Ellis,Narahari S. Pujar Pdf

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

Practical Aspects of Vaccine Development

Parag Kolhe,Satoshi Ohtake
Practical Aspects of Vaccine Development Book PDF

Author : Parag Kolhe,Satoshi Ohtake
Publisher : Elsevier
Page : 386 pages
File Size : 50,6 Mb
Release : 2021-09-08
Category : Business & Economics
ISBN : 9780128143575

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Practical Aspects of Vaccine Development by Parag Kolhe,Satoshi Ohtake Pdf

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates and live vaccines Considers process development for solution, suspension and lyophilized products Explores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Vaccine Analysis: Strategies, Principles, and Control

Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin
Vaccine Analysis Strategies Principles and Control Book PDF

Author : Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin
Publisher : Springer
Page : 669 pages
File Size : 40,6 Mb
Release : 2014-11-27
Category : Medical
ISBN : 9783662450246

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Vaccine Analysis: Strategies, Principles, and Control by Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin Pdf

This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.

The Children's Vaccine Initiative

Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
The Children s Vaccine Initiative Book PDF

Author : Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
Publisher : National Academies Press
Page : 238 pages
File Size : 46,5 Mb
Release : 1993-02-01
Category : Medical
ISBN : 9780309049405

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The Children's Vaccine Initiative by Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies Pdf

The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.

Opportunities in Biotechnology for Future Army Applications

National Research Council,Division on Engineering and Physical Sciences,Board on Army Science and Technology,Committee on Opportunities in Biotechnology for Future Army Applications
Opportunities in Biotechnology for Future Army Applications Book PDF

Author : National Research Council,Division on Engineering and Physical Sciences,Board on Army Science and Technology,Committee on Opportunities in Biotechnology for Future Army Applications
Publisher : National Academies Press
Page : 118 pages
File Size : 54,9 Mb
Release : 2001-07-11
Category : Science
ISBN : 9780309075558

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Opportunities in Biotechnology for Future Army Applications by National Research Council,Division on Engineering and Physical Sciences,Board on Army Science and Technology,Committee on Opportunities in Biotechnology for Future Army Applications Pdf

This report surveys opportunities for future Army applications in biotechnology, including sensors, electronics and computers, materials, logistics, and medical therapeutics, by matching commercial trends and developments with enduring Army requirements. Several biotechnology areas are identified as important for the Army to exploit, either by direct funding of research or by indirect influence of commercial sources, to achieve significant gains in combat effectiveness before 2025.

Priorities for the National Vaccine Plan

Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Review of Priorities in the National Vaccine Plan
Priorities for the National Vaccine Plan Book PDF

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Review of Priorities in the National Vaccine Plan
Publisher : National Academies Press
Page : 368 pages
File Size : 52,6 Mb
Release : 2010-05-17
Category : Medical
ISBN : 9780309156202

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Priorities for the National Vaccine Plan by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Review of Priorities in the National Vaccine Plan Pdf

Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health.

The Anthrax Vaccine

Institute of Medicine,Medical Follow-up Agency,Committee to Assess the Safety and Efficacy of the Anthrax Vaccine
The Anthrax Vaccine Book PDF

Author : Institute of Medicine,Medical Follow-up Agency,Committee to Assess the Safety and Efficacy of the Anthrax Vaccine
Publisher : National Academies Press
Page : 288 pages
File Size : 55,8 Mb
Release : 2002-04-18
Category : Medical
ISBN : 9780309182744

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The Anthrax Vaccine by Institute of Medicine,Medical Follow-up Agency,Committee to Assess the Safety and Efficacy of the Anthrax Vaccine Pdf

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

Exploring Lessons Learned from a Century of Outbreaks

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Forum on Microbial Threats
Exploring Lessons Learned from a Century of Outbreaks Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Forum on Microbial Threats
Publisher : National Academies Press
Page : 231 pages
File Size : 44,7 Mb
Release : 2019-06-05
Category : Medical
ISBN : 9780309490351

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Exploring Lessons Learned from a Century of Outbreaks by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Forum on Microbial Threats Pdf

In November 2018, an ad hoc planning committee at the National Academies of Sciences, Engineering, and Medicine planned two sister workshops held in Washington, DC, to examine the lessons from influenza pandemics and other major outbreaks, understand the extent to which the lessons have been learned, and discuss how they could be applied further to ensure that countries are sufficiently ready for future pandemics. This publication summarizes the presentations and discussions from both workshops.

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines

National Academy of Medicine,National Academies Of Sciences Engineeri,Health And Medicine Division,Board on Global Health,Committee on Addressing Issues of Vaccine Distribution and Supply Chains to Advance Pandemic and Seasonal Influenza Preparedness and Response
Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines Book PDF

Author : National Academy of Medicine,National Academies Of Sciences Engineeri,Health And Medicine Division,Board on Global Health,Committee on Addressing Issues of Vaccine Distribution and Supply Chains to Advance Pandemic and Seasonal Influenza Preparedness and Response
Publisher : National Academies Press
Page : 128 pages
File Size : 41,6 Mb
Release : 2021-12-31
Category : Medical
ISBN : 0309089158

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Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines by National Academy of Medicine,National Academies Of Sciences Engineeri,Health And Medicine Division,Board on Global Health,Committee on Addressing Issues of Vaccine Distribution and Supply Chains to Advance Pandemic and Seasonal Influenza Preparedness and Response Pdf

Influenza viruses, both seasonal and pandemic, have the potential to disrupt the health and well-being of populations around the world. The global response to the COVID-19 pandemic and prior public health emergencies of international concern illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental organizations, the private sector, and the public to address the threat of pandemic influenza. These health emergencies have revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines outlines key findings and recommendations to bolster vaccine distribution, manufacturing, and supply chains for future seasonal and pandemic influenza events. This report addresses the challenges of manufacturing and distributing vaccines for both seasonal and pandemic influenza, highlighting the critical components of vaccine manufacturing and distribution and offering recommendations that would address gaps in the current global vaccine infrastructure.

Veterinary Vaccines

Samia Metwally,Gerrit Viljoen,Ahmed El Idrissi
Veterinary Vaccines Book PDF

Author : Samia Metwally,Gerrit Viljoen,Ahmed El Idrissi
Publisher : John Wiley & Sons
Page : 350 pages
File Size : 46,7 Mb
Release : 2021-04-01
Category : Medical
ISBN : 9781119506263

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Veterinary Vaccines by Samia Metwally,Gerrit Viljoen,Ahmed El Idrissi Pdf

Provides a concise and authoritative reference on the use of vaccines against diseases of livestock Compiled by Senior Animal Health Officers at The Food and Agriculture Organization of the United Nations, and with contributions from international leading experts, Veterinary Vaccines: Principles and Applications is a concise and authoritative reference featuring easily readable reviews of the latest research in vaccinology and vaccine immune response to pathogens of major economic impact to livestock. It covers advice and recommendations for vaccine production, quality control, and effective vaccination schemes including vaccine selection, specifications, vaccination programs, vaccine handling in the field, application, failures, and assessment of herd protection. In addition, the book presents discussions on the current status and potential future developments of vaccines and vaccination against selected transboundary animal diseases. Provides a clear and comprehensive guide on using veterinary vaccines to protect livestock from diseases Teaches the principles of vaccinology and vaccine immune response Highlights the vaccine production schemes and standards for quality control testing Offers easy-to-read reviews of the most current research on the subject Gives readers advice and recommendations on which vaccination schemes are most effective Discusses the today’s state of vaccines and vaccination against selected transboundary animal diseases as well as possible future developments in the field Veterinary Vaccines: Principles and Applications is an important resource for veterinary practitioners, animal health department officials, vaccine scientists, and veterinary students. It will also be of interest to professional associations and NGO active in livestock industry.

Practical Aspects of Vaccine Development

Parag Kolhe,Satoshi Ohtake
Practical Aspects of Vaccine Development Book PDF

Author : Parag Kolhe,Satoshi Ohtake
Publisher : Academic Press
Page : 388 pages
File Size : 41,6 Mb
Release : 2021-09-10
Category : Business & Economics
ISBN : 9780128143582

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Practical Aspects of Vaccine Development by Parag Kolhe,Satoshi Ohtake Pdf

Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines Covers process development for solution, suspension, and lyophilized products Explores the future of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Biological Threats and Terrorism

Institute of Medicine,Board on Global Health,Forum on Emerging Infections
Biological Threats and Terrorism Book PDF

Author : Institute of Medicine,Board on Global Health,Forum on Emerging Infections
Publisher : National Academies Press
Page : 335 pages
File Size : 40,8 Mb
Release : 2002-03-07
Category : Political Science
ISBN : 9780309169950

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Biological Threats and Terrorism by Institute of Medicine,Board on Global Health,Forum on Emerging Infections Pdf

In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.

Pharmaceutical Biotechnology

Oliver Kayser,Heribert Warzecha
Pharmaceutical Biotechnology Book PDF

Author : Oliver Kayser,Heribert Warzecha
Publisher : John Wiley & Sons
Page : 677 pages
File Size : 54,6 Mb
Release : 2012-05-21
Category : Science
ISBN : 9783527329946

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Pharmaceutical Biotechnology by Oliver Kayser,Heribert Warzecha Pdf

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

Vaccinology

Gregg N. Milligan,Alan D. T. Barrett
Vaccinology Book PDF

Author : Gregg N. Milligan,Alan D. T. Barrett
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 47,8 Mb
Release : 2015-02-16
Category : Medical
ISBN : 9780470656167

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Vaccinology by Gregg N. Milligan,Alan D. T. Barrett Pdf

Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.