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Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
Author: Emily P. Wen
Publisher: John Wiley & Sons
Total Pages: 452
Release: 2014-10-06
Genre: Technology & Engineering
ISBN: 1118870905

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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


Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development
Author: Parag Kolhe
Publisher: Elsevier
Total Pages: 386
Release: 2021-09-08
Genre: Business & Economics
ISBN: 0128143576

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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 Development: From Concept to Clinic

Vaccine Development: From Concept to Clinic
Author: A. Krishna Prasad
Publisher: Royal Society of Chemistry
Total Pages: 323
Release: 2022-11-09
Genre: Medical
ISBN: 178801877X

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Utilising successful case studies Vaccine Development will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development.


Vaccine Analysis: Strategies, Principles, and Control

Vaccine Analysis: Strategies, Principles, and Control
Author: Brian K. Nunnally
Publisher: Springer
Total Pages: 669
Release: 2014-11-27
Genre: Medical
ISBN: 3662450240

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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.


Opportunities in Biotechnology for Future Army Applications

Opportunities in Biotechnology for Future Army Applications
Author: National Research Council
Publisher: National Academies Press
Total Pages: 118
Release: 2001-07-11
Genre: Science
ISBN: 0309075556

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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.


The Anthrax Vaccine

The Anthrax Vaccine
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 288
Release: 2002-04-18
Genre: Medical
ISBN: 0309182743

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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.


Priorities for the National Vaccine Plan

Priorities for the National Vaccine Plan
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 368
Release: 2010-05-17
Genre: Medical
ISBN: 0309156203

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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.


Pharmaceutical Biotechnology

Pharmaceutical Biotechnology
Author: Oliver Kayser
Publisher: John Wiley & Sons
Total Pages: 677
Release: 2012-05-21
Genre: Science
ISBN: 3527329943

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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.


Exploring Lessons Learned from a Century of Outbreaks

Exploring Lessons Learned from a Century of Outbreaks
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 231
Release: 2019-06-05
Genre: Medical
ISBN: 0309490359

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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

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines
Author: National Academy of Medicine
Publisher: National Academies Press
Total Pages:
Release: 2021-12-31
Genre: Medical
ISBN: 9780309089159

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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.