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Exam Prep for: Formulation, Development and Manufacturing of ...

Exam Prep for: Formulation, Development and Manufacturing of ...
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2021
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
A Book

by Emily P. Wen,Ronald Ellis,Narahari S. Pujar

  • Publisher : John Wiley & Sons
  • Release : 2014-10-06
  • Pages : 456
  • ISBN : 1118870905
  • Language : En, Es, Fr & De
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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
A Book

by Parag Kolhe,Satoshi Ohtake

  • Publisher : Academic Press
  • Release : 2021-06-01
  • Pages : 410
  • ISBN : 0128143584
  • Language : En, Es, Fr & De
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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

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
Modality-Based Approaches

by Dushyant Varshney,Manmohan Singh

  • Publisher : Springer
  • Release : 2015-05-19
  • Pages : 401
  • ISBN : 1493923838
  • Language : En, Es, Fr & De
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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.

Vaccines E-Book

Vaccines E-Book
A Book

by Stanley A. Plotkin,Walter Orenstein,Paul A. Offit,Kathryn M. Edwards

  • Publisher : Elsevier Health Sciences
  • Release : 2017-04-07
  • Pages : 1376
  • ISBN : 0323393012
  • Language : En, Es, Fr & De
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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.

The Anthrax Vaccine Immunization Program--what Have We Learned?

The Anthrax Vaccine Immunization Program--what Have We Learned?
Hearings Before the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, Second Session, October 3 and 11, 2000

by United States,United States. Congress. House. Committee on Government Reform

  • Publisher : Unknown Publisher
  • Release : 2001
  • Pages : 1108
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Vaccines

Vaccines
A Book

by Stanley A. Plotkin,Walter A. Orenstein,Paul A. Offit

  • Publisher : Elsevier Health Sciences
  • Release : 2012-10
  • Pages : 1550
  • ISBN : 1455700908
  • Language : En, Es, Fr & De
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2013 BMA Medical Book Awards Highly Commended in Public Health! Apply the latest vaccination knowledge with a reference that Bill Gates calls "an indispensable guide to the enhancement of the well-being of our world." Inside Vaccines, you'll find comprehensive and current coverage of every aspect of vaccination, from the development of each vaccine to its use in reducing disease. This medical reference book offers the expert information you need to apply the very latest techniques and information in your practice! Gain a complete understanding of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. Update your knowledge of both existing vaccines and vaccines currently in the research and development stage. Get complete answers on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. Analyze the cost-benefit and cost-effectiveness of different vaccine options. Clearly visualize concepts and objective data through an abundance of tables and figures. Perform seamless searches of the complete text online, access all the references, and download all the images at www.expertconsult.com. Make optimal use of the latest vaccines for pneumococcal disease, rotavirus, human papillomavirus, herpes zoster, meningococcal disease, and much more. Stay at the forefront of new developments with completely updated chapters on malaria and HIV vaccines, a new chapter on vaccine regulations across the world, and many other revisions throughout.

The Role of Diaspora in Technology Transfer and Achieving Sustainable Development in Sudan

The Role of Diaspora in Technology Transfer and Achieving Sustainable Development in Sudan
A Book

by Allam Ahmed

  • Publisher : Routledge
  • Release : 2009
  • Pages : 214
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This volume includes a wide range (research areas and topics) of papers, projects, proposals and case studies presented during the First Sudanese Diaspora International Conference, held in January 2009 in Brighton, United Kingdom.Sudan like much of the rest of the developing world has toyed with and abided by various approaches or strategies to transfer technology (TT) and achieve sustainable development (SD) without reaping any significant socio-economic benefits. The Sudanese diasporic community is relatively large and has a significant impact on Sudan development on account of the size and volume of financial remittances. However diasporic contribution is largely neglected within national science and technology policies and strategies. Adopting a more holistic approach, the conference aims to provide a stimulus for knowledge exchange and discussion that focuses on issues relating to the role of diaspora in TT and achieving SD to critically examine the relations and links between diaspora, Sudan and host countries, and attempts to outline policy and strategies to support the role of diaspora in developing, creating wealth and achieving SD in Sudan. The conference also aims to learn lessons from the successful communities across the world and emulate the ideas and innovations of these communities by Sudan.It is hoped that the ensemble of papers presented in this volume will help to stimulate debate amongst scholars, researchers and policymakers and that readers will find this volume interesting and thought-provoking. The seven main sections include: Diaspora Contribution to Home CountryTechnology and Scientific Knowledge TransferEducation, Training and DevelopmentMedical Sciences and Public HealthEngineering Applications and Sustainable Business ExcellenceEnvironment and Waste ManagementAbstracts for Oral Presentations

Doing Business in Boston

Doing Business in Boston
A Book

by Jeffrey P. Levine

  • Publisher : Unknown Publisher
  • Release : 1996-06
  • Pages : 974
  • ISBN : 9780964098916
  • Language : En, Es, Fr & De
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New Scientist

New Scientist
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Combined Vaccines and Simultaneous Administration

Combined Vaccines and Simultaneous Administration
Current Issues and Perspectives

by Jim C. Williams

  • Publisher : Unknown Publisher
  • Release : 1995
  • Pages : 404
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This text brings together contributions from members of the scientific, public health and regulatory communities on areas of vaccinology addressing safety, immunogenicity, protective efficacy, development of immunologic correlates of protection and manufacturing issues. Scientific advances and regulatory issues bearing on the development of combination vaccines and vaccines for simultaneous administration are discussed. The goals and impact of the Children's Vaccines Initiative are considered.

The Bullion

The Bullion
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1999
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Preclinical and Clinical Development of New Vaccines

Preclinical and Clinical Development of New Vaccines
Institut Pasteur, Paris, France 27-28 May 1997

by Stanley A. Plotkin,Fred Brown,Florian Horaud

  • Publisher : S Karger Ag
  • Release : 1998
  • Pages : 280
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This publication covers all aspects of new vaccine development from the preclinical stage to licensing. It contains discussions about the preclinical testing which is necessary to obtain permission to test a new vaccine in clinical trials and to organize a clinical plan that will demonstrate the safety and efficacy of a new vaccine. In addition, some aspects of newer strategies, such as DNA immunization, are presented as well as a number of theoretical issues relating to vaccination, such as immunological correlates of protection, interference with immune responses, combination of vaccines, and the natural history of disease. Much attention is devoted to the proof of efficacy, a process which is both expensive and complicated. This volume is important reading for all scientists interested in vaccine development, especially those working in industry, government and public health authorities.

Vaccine Design

Vaccine Design
The Subunit and Adjuvant Approach

by Michael F. Powell,Mark J. Newman

  • Publisher : Springer
  • Release : 2012-12-06
  • Pages : 949
  • ISBN : 1461518237
  • Language : En, Es, Fr & De
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When my interest was first drawn to the phenomenon of vaccination for virus diseases in the late 1930s, the state of the art and the science of vaccine design was not far advanced beyond the time of Jenner at the end of the 18th century and of Pasteur a century later. In the 1930s it was still believed that for the induction of immunity to a virus-caused disease the experience of infection was required, but not for a toxin-caused disease such as diphtheria or tetanus, for which a chemically detoxified antigen was effective for immu nization. This prompted the question as to whether it might be possible to produce a similar effect for virus diseases using nonreplicating antigens. When in the 1930s and 1940s it was found possible to propagate influenza viruses in the chick embryo, protective effects could be induced without the need to experience infection by the use of a sufficient dose of a noninfectious influenza virus preparation. Later in the 1940s, it became possible to propagate polio and other viruses in cultures of human and monkey tissue and to immunize against other virus diseases in the same way. Later, with the advent of the era of molecular biology and genetic engineering, antigens and vaccines could be produced in new and creative ways, using either replicating or nonreplicating forms of the appropriate antigens for inducing a dose-related protective state.

the worldwide biotech industry reporting service

the worldwide biotech industry reporting service
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Manual of Standards for Diagnostic Tests and Vaccines

Manual of Standards for Diagnostic Tests and Vaccines
Lists A and B Diseases of Mammals, Birds and Bees

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 957
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Fiebre Aftosa

Fiebre Aftosa
Afrontar Los Nuevos Dilemas

by G. R. Thomson

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 493
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Sterile Product Development

Sterile Product Development
Formulation, Process, Quality and Regulatory Considerations

by Parag Kolhe,Mrinal Shah,Nitin Rathore

  • Publisher : Springer Science & Business Media
  • Release : 2013-10-12
  • Pages : 585
  • ISBN : 1461479789
  • Language : En, Es, Fr & De
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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.

Science

Science
A Book

by John Michels

  • Publisher : Unknown Publisher
  • Release : 2001-02
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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BioScan

BioScan
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2009
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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