Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches

Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches PDF 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.

Glyco-Engineering

Glyco-Engineering PDF Author: Alexandra Castilho
Publisher: Humana
ISBN: 9781493927593
Category : Science
Languages : en
Pages : 0

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Book Description
Conceived with the intention of providing an array of strategies and technologies currently in use for glyco-engineering distinct living organisms, this book contains a wide range of methods being developed to control the composition of carbohydrates and the properties of proteins through manipulations on the production host rather than in the protein itself. The first five sections deal with host-specific glyco-engineering and contain chapters that provide protocols for modifications of the glycosylation pathway in bacteria, yeast, insect, plants and mammalian cells, while the last two sections explore alternative approaches to host glyco-engineering and selected protocols for the analysis of the N-glycans and glyco-profiling by mass spectrometry. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols and tips on troubleshooting and avoiding known pitfalls. Authoritative and extensive, Glyco-Engineering: Methods and Protocols offers vast options to help researchers to choose the expression system and approach that best suits their intended protein research or applications.

Blue Marble Health

Blue Marble Health PDF 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.

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development PDF 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

Synthetic mRNA

Synthetic mRNA PDF 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.

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing PDF Author: Emily P. Wen
Publisher: John Wiley & Sons
ISBN: 1118870905
Category : Technology & Engineering
Languages : en
Pages : 452

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Book Description
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

The Vaccine Book

The Vaccine Book PDF 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

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals PDF Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Category : Science
Languages : en
Pages : 986

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Book Description
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Protein Therapeutics

Protein Therapeutics PDF Author: Zuben E. Sauna
Publisher: Springer
ISBN: 3319418181
Category : Science
Languages : en
Pages : 192

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Book Description
Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

China and the Origins of Immunology

China and the Origins of Immunology PDF Author: Joseph Needham
Publisher:
ISBN:
Category : Immunization
Languages : en
Pages : 46

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Book Description
Immunologie / Geschichte / China.