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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 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


History of Vaccine Development

History of Vaccine Development
Author: Stanley A. Plotkin
Publisher: Springer Science & Business Media
Total Pages: 352
Release: 2011-05-11
Genre: Medical
ISBN: 1441913394

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Vaccinology, the concept of a science ranging from the study of immunology to the development and distribution of vaccines, was a word invented by Jonas Salk. This book covers the history of the methodological progress in vaccine development and to the social and ethical issues raised by vaccination. Chapters include "Jenner and the Vaccination against Smallpox," "Viral Vaccines," and "Ethical and Social Aspects of vaccines." Contributing authors include pioneers in the field, such as Samuel L. Katz and Hilary Koprowski. This history of vaccines is relatively short and many of its protagonists are still alive. This book was written by some of the chief actors in the drama whose subject matter is the conquest of epidemic disease.


Vaccines for the 21st Century

Vaccines for the 21st Century
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 472
Release: 2001-02-21
Genre: Medical
ISBN: 0309174988

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Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis. What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development. This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines: Lessons to be learned from the polio experience. Scientific advances that set the stage for new vaccines. Factors that affect how vaccines are used in the population. Value judgments and ethical questions raised by comparison of health needs and benefits. The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.


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.


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.


The Design and Development of Novel Drugs and Vaccines

The Design and Development of Novel Drugs and Vaccines
Author: Tarun Kumar Bhatt
Publisher: Academic Press
Total Pages: 310
Release: 2021-01-21
Genre: Business & Economics
ISBN: 0128214759

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The Design and Development of Novel Drugs and Vaccines: Principles and Protocols presents both in silico methods and experimental protocols for vaccine and drug design and development, critically reviewing the most current research and emphasizing approaches and technologies that accelerate and lower the cost of product development. Sections review the technologies and approaches used to identify, characterize and establish a protein as a new drug and vaccine target, cover several molecular methods for in vitro studies of the desired target, and present various physiological parameters for in vivo studies. The book includes preclinical trials and research, along with information on FDA approval. Covers both in silico methods and experimental protocols for vaccine and drug development in a single, accessible volume Offers a holistic accounting of how developments in bioinformatics and large experimental datasets can be used in the development of vaccines and drugs Shows researchers the entire gamut of current therapies, ranging from computational inputs to animal studies Reviews the most current, cutting-edge research available on vaccine and drug design and development


Vaccines

Vaccines
Author: Stanley A. Plotkin
Publisher: Elsevier Health Sciences
Total Pages: 1748
Release: 2008-02-11
Genre: Medical
ISBN: 1437721583

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Completely revised and updated, this respected reference offers comprehensive and current coverage of every aspect of vaccination-from development to use in reducing disease. It provides authoritative information on vaccine production, available preparations, efficacy, and safety...recommendations for vaccine use, with rationales...data on the impact of vaccination programs on morbidity and mortality...and more. And now, as an Expert Consult title, it includes a companion web site offering this unparalleled guidance where and when you need it most! Provides a complete understanding of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well an epidemiology and public health issues. Offers comprehensive coverage of both existing vaccines and vaccines currently in the research and development stage. Examines vaccine stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease control strategies. Analyses the cost-benefit and cost-effectiveness of vaccines. Discusses the proper use of immune globulins and antitoxins. Illustrates concepts and objective data with approximately 600 tables and figures. Includes access to a companion web site offering the complete contents of the book - fully searchable - for rapid consultation from anyplace with an Internet connection.


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.


A Shot to Save the World

A Shot to Save the World
Author: Gregory Zuckerman
Publisher: Penguin
Total Pages: 384
Release: 2021-10-26
Genre: Business & Economics
ISBN: 0593420403

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"An inspiring and informative page-turner." –Walter Isaacson Longlisted for the FT/McKinsey Business Book of the Year Award The authoritative account of the race to produce the vaccines that are saving us all, from the #1 New York Times bestselling author of The Man Who Solved the Market Few were ready when a mysterious respiratory illness emerged in Wuhan, China in January 2020. Politicians, government officials, business leaders, and public-health professionals were unprepared for the most devastating pandemic in a century. Many of the world’s biggest drug and vaccine makers were slow to react or couldn’t muster an effective response. It was up to a small group of unlikely and untested scientists and executives to save civilization. A French businessman dismissed by many as a fabulist. A Turkish immigrant with little virus experience. A quirky Midwesterner obsessed with insect cells. A Boston scientist employing questionable techniques. A British scientist despised by his peers. Far from the limelight, each had spent years developing innovative vaccine approaches. Their work was met with skepticism and scorn. By 2020, these individuals had little proof of progress. Yet they and their colleagues wanted to be the ones to stop the virus holding the world hostage. They scrambled to turn their life’s work into life-saving vaccines in a matter of months, each gunning to make the big breakthrough—and to beat each other for the glory that a vaccine guaranteed. A #1 New York Times bestselling author and award-winning Wall Street Journal investigative journalist lauded for his “bravura storytelling” (Gary Shteyngart) and “first-rate” reporting (The New York Times), Zuckerman takes us inside the top-secret laboratories, corporate clashes, and high-stakes government negotiations that led to effective shots. Deeply reported and endlessly gripping, this is a dazzling, blow-by-blow chronicle of the most consequential scientific breakthrough of our time. It’s a story of courage, genius, and heroism. It’s also a tale of heated rivalries, unbridled ambitions, crippling insecurities, and unexpected drama. A Shot to Save the World is the story of how science saved the world.