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Formulation Development And Manufacturing Of Vaccines

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Vaccine Development and Manufacturing

Vaccine Development and Manufacturing Book
Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher : John Wiley & Sons
Release : 2014-10-06
ISBN : 1118870905
Language : En, Es, Fr & De

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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

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development Book
Author : Parag Kolhe,Satoshi Ohtake
Publisher : Elsevier
Release : 2021-09-24
ISBN : 0128143576
Language : En, Es, Fr & De

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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

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing Book
Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher : John Wiley & Sons
Release : 2014-11-17
ISBN : 0470261943
Language : En, Es, Fr & De

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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

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines Book
Author : Dushyant Varshney,Manmohan Singh
Publisher : Springer
Release : 2015-05-19
ISBN : 1493923838
Language : En, Es, Fr & De

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Book Description :

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development Book
Author : Parag Kolhe,Satoshi Ohtake
Publisher : Academic Press
Release : 2021-09-17
ISBN : 0128143584
Language : En, Es, Fr & De

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Book Description :

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

Vaccines development and manufacturing process

Vaccines development and manufacturing process Book
Author : Bruce Wembulua
Publisher : GRIN Verlag
Release : 2016-11-21
ISBN : 3668344701
Language : En, Es, Fr & De

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Book Description :

Essay from the year 2016 in the subject Medicine - Public Health, grade: 80/100, , course: Tropical Medicine-Immuniwation and surveillance, language: English, abstract: This paper explains how vaccines are developed and describes in detail their manufacturing process The Greeks had two gods of health: Aesculapius and Hygieia, therapy and prevention, respectively. Medicine in the twentieth century retains those two concepts, and vaccination is a powerful means of prevention. Vaccines provide the immunity that comes from natural infection without the consequences of natural infection; help protect people from harmful infections before they come in contact with the disease. Vaccines may also help alleviate the symptoms of the infection caused by the virus.Vaccines provide the immunity that comes from natural infection without the consequences of natural infection. Vaccine development is difficult, complex, highly risky, and costly and includes clinical development, process development and assay development. Vaccine development requires strong management systems and controls, and requisite skill sets among scientists and engineers. Pharmaceutical companies must demonstrate the safety and efficacy of a medicinal product or vaccine through the use of clinical trials, before a regulatory authority registers the product. The vast majority of over one billion doses of vaccines manufactured worldwide each year are given to perfectly healthy individuals. It is this fact that drives the requirements for vaccines to be among the most rigorously designed, monitored and compliant products manufactured today.

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development Book
Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
Publisher : Springer
Release : 2015-04-01
ISBN : 1493923161
Language : En, Es, Fr & De

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Book Description :

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Hope for the Future Developing an Hiv aids Vaccine

Hope for the Future   Developing an Hiv aids Vaccine Book
Author : Anonim
Publisher : DIANE Publishing
Release : 2022-06-27
ISBN : 1422333000
Language : En, Es, Fr & De

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Book Description :

Download Hope for the Future Developing an Hiv aids Vaccine book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Delivery Systems for Tuberculosis Prevention and Treatment

Delivery Systems for Tuberculosis Prevention and Treatment Book
Author : Anthony J. Hickey
Publisher : John Wiley & Sons
Release : 2016-08-25
ISBN : 1118943201
Language : En, Es, Fr & De

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Book Description :

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs Presents a novel perspective on tuberculosis prevention and treatment Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

Antiviral Discovery for Highly Pathogenic Emerging Viruses

Antiviral Discovery for Highly Pathogenic Emerging Viruses Book
Author : Rafael Delgado,Cesar Munoz-Fontela
Publisher : Royal Society of Chemistry
Release : 2021-12-08
ISBN : 1788015649
Language : En, Es, Fr & De

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Book Description :

Ideal for drug discovery scientists and medicinal chemists with an interest in antiviral drug discovery and development, this book provides a complete overview of the latest progress in the field, recent advances and the challenges that remain in developing these highly pathogenic agents.

The Vaccine Book

The Vaccine Book Book
Author : Barry R. Bloom,Paul-Henri Lambert
Publisher : Academic Press
Release : 2016-06-23
ISBN : 012805400X
Language : En, Es, Fr & De

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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

Vaccines E Book

Vaccines E Book Book
Author : Stanley A. Plotkin,Walter Orenstein,Paul A. Offit,Kathryn M. Edwards
Publisher : Elsevier Health Sciences
Release : 2017-04-07
ISBN : 0323393012
Language : En, Es, Fr & De

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Book Description :

From the development of each vaccine to its use in reducing disease, Plotkin’s Vaccines, 7th Edition, provides the expert information you need to provide optimal care to your patients. This award-winning text offers a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as "an indispensable guide to the enhancement of the well-being of our world," Plotkin’s Vaccines is a must-have reference for current, authoritative information in this fast-moving field. Includes complete information for each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, epidemiology, and public health and regulatory issues – plus complete information for each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. Analyzes the cost-benefit and cost-effectiveness of different vaccine options. Helps you clearly visualize concepts and objective data through an abundance of tables and figures. Covers the new oral cholera and zoster vaccines, as well as newly licensed meningococcal group B vaccines and a newly licensed dengue vaccine. Brings you up to date on successful human trials of Ebola vaccines, an enterovirus 71 vaccine licensed in China, and new recommendations and changes to polio vaccines. Features a new chapter on maternal immunization.

Research and Development of Vaccines and Pharmaceuticals from Biotechnology

Research and Development of Vaccines and Pharmaceuticals from Biotechnology Book
Author : Jens-Peter Gregersen
Publisher : John Wiley & Sons
Release : 2008-07-11
ISBN : 3527615822
Language : En, Es, Fr & De

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Book Description :

Unique in approach, exhaustive in coverage: this book provides information usually not available to scientists. It explains the basic scientific and technical requirements which apply to the patenting and registration of human or veterinary vaccines and therapeutic biomedicinal products. Pragmatic and practice-oriented, it helps users select and manage successfully the most attractive research and development projects. An impressive number of topics is covered, including: * planning and managing product development * product development phases * requirements for a patentable invention * patent costs * user safety * ecotoxicity The book will rapidly pay for itself by more successful fund applications,increased protection and remuneration of intellectual property, and by faster and more efficient product development.

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics Book
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release : 2013-06-27
ISBN : 0123948231
Language : En, Es, Fr & De

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Book Description :

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

Vaccines

Vaccines Book
Author : Stanley A. Plotkin,Walter A. Orenstein,Paul A. Offit
Publisher : Elsevier Health Sciences
Release : 2008
ISBN : 1416036113
Language : En, Es, Fr & De

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Book Description :

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 also includes access to a companion Web site for more coverage.

Sterile Product Development

Sterile Product Development Book
Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Release : 2013-10-12
ISBN : 1461479789
Language : En, Es, Fr & De

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Book Description :

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Vaccines for Biodefense and Emerging and Neglected Diseases

Vaccines for Biodefense and Emerging and Neglected Diseases Book
Author : Alan D.T. Barrett,Lawrence R. Stanberry
Publisher : Academic Press
Release : 2009-03-05
ISBN : 9780080919027
Language : En, Es, Fr & De

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Book Description :

The last 20 years has seen a rapid increase in infectious diseases, particularly those that are termed "emerging diseases" such as SARS, "neglected diseases" such as malaria and those that are deemed biothreats such as anthrax. It is well-recognized that the most effective modality for preventing infectious diseases is vaccination. This book provides researchers with a better understanding of what is currently known about these diseases, including whether there is a vaccine available or under development. It also informs readers of the key issues in development of a vaccine for each disease. * Provides a comprehensive treatise of the agents that are responsible for emerging and neglected diseases and those that can be used as biothreats * Includes the processes such as the vaccine development pathway, vaccine manufacturing and regulatory issues that are critical to the generation of these vaccines to the marketplace * Each chapter will include a map of the world showing where that particular disease is naturally found

Vaccine Protocols

Vaccine Protocols Book
Author : Andrew Robinson,Michael J. Hudson,Michael Hudson,Martin P. Cranage
Publisher : Springer Science & Business Media
Release : 2003
ISBN : 1592593992
Language : En, Es, Fr & De

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Book Description :

This extensively revised, updated, and expanded second edition of a classic laboratory manual applies new understanding of molecular mechanisms to the rational design and development of vaccines. Here the working researcher will find readily reproducible techniques for the development and production of live attenuated vaccines, and vaccines based on inactivated toxins, peptides, and polysaccharide conjugates.

Gene Vaccines

Gene Vaccines Book
Author : Josef Thalhamer,Richard Weiss,Sandra Scheiblhofer
Publisher : Springer Science & Business Media
Release : 2011-08-31
ISBN : 9783709104392
Language : En, Es, Fr & De

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Book Description :

The induction of antigen-specific immune responses after in vivo transfection with expression plasmids has triggered a revolution of vaccine research. After a first hype, evoked by the fascinating options of this method, clinical studies did not reach the ambitious aims and a phase of disillusion ensued. It became obvious that Gene vaccines displayed a weaker immunogenicity in humans than had been observed in the mouse models. Meanwhile these hurdles have been overcome and gene vaccines undergo a renaissance. The present book gives an update of the “world of naked gene vaccines”, namely DNA and RNA vaccines. Its content ranges from general mechanisms, inherent immunostimulatory properties and the vast potential to modulate immune responses, to recent successful clinical studies and approved veterinary gene vaccines. Beyond the state-of-the-art of genetic immunization, the reader will be stimulated with a chapter addressing “burning questions”.

Vaccine Adjuvants and Delivery Systems

Vaccine Adjuvants and Delivery Systems Book
Author : Manmohan Singh
Publisher : John Wiley & Sons
Release : 2007-08-03
ISBN : 9780470134924
Language : En, Es, Fr & De

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Book Description :

The authoritative reference on recent developments in vaccinology New technologies, including recombinant protein and DNA, have sparked phenomenal progress in vaccine development and delivery systems. This unique resource brings scientists up to date on recent advances and provides the information they need to select candidate adjuvants. With chapters written by leading experts in their fields, Vaccine Adjuvants and Delivery Systems: * Provides a comprehensive overview of the rapidly evolving field and developing formulation methods * Covers cutting-edge technologies and gives the current status of adjuvants in clinical trials and those still in the pre-clinical stage * Includes detailed information on specific vaccine adjuvants, including MF59, TLR4 agonists, new iscoms, cytokines, polyphosphazenes, and more * Provides a historical perspective on the development of vaccine adjuvants and discusses the mechanisms of adjuvant actions * Covers some novel adjuvants and delivery systems and the safety evaluation of adjuvants A great reference for researchers, scientists, and students in vaccinology, biotechnology, immunology, and molecular biology, this resource is also valuable for researchers and scientists in veterinary medicine who work to prevent diseases in animals.