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Author: National Research Council
Publisher: National Academies Press
ISBN: 0309153212
Category : Medical
Languages : en
Pages : 38
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Book Description
A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure-currently defined as enough material to treat or vaccinate 3 million personnel-within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014. The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"-repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309153212
Category : Medical
Languages : en
Pages : 38
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Book Description
A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure-currently defined as enough material to treat or vaccinate 3 million personnel-within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014. The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"-repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Category : Medical
Languages : en
Pages : 69
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Book Description
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Author: Parag Kolhe
Publisher: Elsevier
ISBN: 0128143576
Category : Business & Economics
Languages : en
Pages : 386
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Book Description
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
Author: Joseph Needham
Publisher:
ISBN:
Category : Immunization
Languages : en
Pages : 46
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Book Description
Immunologie / Geschichte / China.
Author: Robert E. Rhoads
Publisher: Humana
ISBN: 9781493936236
Category : Medical
Languages : en
Pages : 0
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Book Description
This volume presents detailed laboratory protocols for in vitro synthesis of mRNA with favorable properties, its introduction into cells by a variety of techniques, and the measurement of physiological and clinical consequences such as protein replacement and cancer immunotherapy. Synthetic techniques are described for structural features in mRNA that provide investigational tools such as fluorescence emission, click chemistry, photo-chemical crosslinking, and that produce mRNA with increased stability in the cell, increased translational efficiency, and reduced activation of the innate immune response. Protocols are described for clinical applications such as large-scale transfection of dendritic cells, production of GMP-grade mRNA, redirecting T cell specificity, and use of molecular adjuvants for RNA vaccines. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Synthetic mRNA: Production, Introduction into Cells, and Physiological Consequences is a valuable and cutting-edge resource for both laboratory investigators and clinicians interested in this powerful and rapidly evolving technology.
Author: Peter J. Hotez
Publisher: JHU Press
ISBN: 1421420465
Category : Law
Languages : en
Pages : 224
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Book Description
Why do diseases of poverty afflict more people in wealthy countries than in the developing world? In 2011, Dr. Peter J. Hotez relocated to Houston to launch Baylor’s National School of Tropical Medicine. He was shocked to discover that a number of neglected diseases often associated with developing countries were widespread in impoverished Texas communities. Despite the United States’ economic prowess and first-world status, an estimated 12 million Americans living at the poverty level currently suffer from at least one neglected tropical disease, or NTD. Hotez concluded that the world’s neglected diseases—which include tuberculosis, hookworm infection, lymphatic filariasis, Chagas disease, and leishmaniasis—are born first and foremost of extreme poverty. In this book, Hotez describes a new global paradigm known as “blue marble health,” through which he asserts that poor people living in wealthy countries account for most of the world’s poverty-related illness. He explores the current state of neglected diseases in such disparate countries as Mexico, South Korea, Argentina, Australia, the United States, Japan, and Nigeria. By crafting public policy and relying on global partnerships to control or eliminate some of the world’s worst poverty-related illnesses, Hotez believes, it is possible to eliminate life-threatening disease while at the same time creating unprecedented opportunities for science and diplomacy. Clear, compassionate, and timely, Blue Marble Health is a must-read for leaders in global health, tropical medicine, and international development, along with anyone committed to helping the millions of people who are caught in the desperate cycle of poverty and disease.
Author: Barry R. Bloom
Publisher: Academic Press
ISBN: 012805400X
Category : Medical
Languages : en
Pages : 666
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Book Description
The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child's risk. - Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines - Gives new ideas about future vaccines and concepts - Introduces new vaccines and concepts - Gives ideas about challenges facing public and private industrial investors in the vaccine area - Discusses the problem of declining immunization rates and vaccine hesitancy
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Stanley A. Plotkin
Publisher: Springer Science & Business Media
ISBN: 1441913394
Category : Medical
Languages : en
Pages : 352
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030916995X
Category : Political Science
Languages : en
Pages : 335
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Book Description
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.
