Download Formulation, Development and Manufacturing of Vaccines Ebook PDF

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
GET BOOK

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
Modality-Based Approaches

by Dushyant Varshney,Manmohan Singh

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

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.

Formulation, Development and Manufacturing of Vaccines

Formulation, Development and Manufacturing of Vaccines
The Practical Aspects

by Satoshi Ohtake,Parag Kolhe

  • Publisher : Academic Press
  • Release : 2019-05-15
  • Pages : 410
  • ISBN : 9780128143575
  • Language : En, Es, Fr & De
GET BOOK

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

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
GET BOOK

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.

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
GET BOOK

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.

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
A Book

by Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe

  • Publisher : Springer
  • Release : 2015-04-01
  • Pages : 710
  • ISBN : 1493923161
  • Language : En, Es, Fr & De
GET BOOK

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.

The Vaccine Book

The Vaccine Book
A Book

by Barry R. Bloom,Paul-Henri Lambert

  • Publisher : Academic Press
  • Release : 2016-06-23
  • Pages : 664
  • ISBN : 012805400X
  • Language : En, Es, Fr & De
GET BOOK

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

I-Bytes Technology Industry

I-Bytes Technology Industry
A Book

by IT Shades

  • Publisher : EGBG Services LLC
  • Release : 2020-10-13
  • Pages : 130
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

This document brings together a set of latest data points and publicly available information relevant for Technology Industry. We are very excited to share this content and believe that readers will benefit from this periodic publication immensely.

Current Applications of Pharmaceutical Biotechnology

Current Applications of Pharmaceutical Biotechnology
A Book

by Ana Catarina Silva,João Nuno Moreira,José Manuel Sousa Lobo,Hugo Almeida

  • Publisher : Springer Nature
  • Release : 2020-02-06
  • Pages : 400
  • ISBN : 3030404641
  • Language : En, Es, Fr & De
GET BOOK

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account.

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Pharmaceutical Inhalation Aerosol Technology, Third Edition
A Book

by Anthony J. Hickey,Sandro R. da Rocha

  • Publisher : CRC Press
  • Release : 2019-03-26
  • Pages : 730
  • ISBN : 042962171X
  • Language : En, Es, Fr & De
GET BOOK

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
An Introduction for Pharmacists, Physicians and Other Health Practitioners

by Iqbal Ramzan

  • Publisher : John Wiley & Sons
  • Release : 2021-02-03
  • Pages : 320
  • ISBN : 1119564654
  • Language : En, Es, Fr & De
GET BOOK

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Hope for the Future : Developing an Hiv/aids Vaccine

Hope for the Future : Developing an Hiv/aids Vaccine
A Book

by Anonim

  • Publisher : DIANE Publishing
  • Release : 2021
  • Pages : 329
  • ISBN : 1422333000
  • Language : En, Es, Fr & De
GET BOOK

Parenteral Medications, Fourth Edition

Parenteral Medications, Fourth Edition
A Book

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2019-08-08
  • Pages : 1125
  • ISBN : 042957472X
  • Language : En, Es, Fr & De
GET BOOK

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

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
Summary of a Workshop

by National Research Council,Division on Earth and Life Studies,Board on Life Sciences

  • Publisher : National Academies Press
  • Release : 2010-07-09
  • Pages : 38
  • ISBN : 0309153212
  • Language : En, Es, Fr & De
GET BOOK

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.

Delivery Systems for Tuberculosis Prevention and Treatment

Delivery Systems for Tuberculosis Prevention and Treatment
A Book

by Anthony J. Hickey

  • Publisher : John Wiley & Sons
  • Release : 2016-08-25
  • Pages : 456
  • ISBN : 1118943198
  • Language : En, Es, Fr & De
GET BOOK

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

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.
A Book

by World Intellectual Property Organization

  • Publisher : WIPO
  • Release : 2020-07-28
  • Pages : 347
  • ISBN : 9280531743
  • Language : En, Es, Fr & De
GET BOOK

This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.

Curious2018

Curious2018
Future Insights in Science and Technology

by Ulrich A.K. Betz

  • Publisher : Springer
  • Release : 2019-08-13
  • Pages : 162
  • ISBN : 3030160610
  • Language : En, Es, Fr & De
GET BOOK

This book expands the debate on the future of science and technology at the Curious2018 – Future Insight Conference, held on the occasion of Merck’s 350-year anniversary. In the respective chapters, some of the world’s top scientists, managers and entrepreneurs explore breakthrough technologies and how they can be applied to make a better world for humanity. Divided into three parts, the book begins with an introduction to the vision of the conference and to the importance of curiosity for innovation, while also exploring the latest scientific developments that are shaping the future of healthcare, medicine, the life and material sciences, digitalization and new ways of working together. In the second part, particular attention is paid to new therapies and diagnostics; here, readers will learn how synthetic biology and chemistry are being used to solve problems that are essential to the future of humanity. The role of in-silico research is also discussed. In the final part of the book, readers will find some thoughts on ethical principles guiding our application of science and technology to create a bright future for humanity. Given its interdisciplinary appeal, the book will inspire curiosity in a wide readership, from scholars and researchers to professionals with an interest in exploring the future of science and technology, solving the problems of today, and paving the way for a better tomorrow. Chapters 1, 2, 3 and 17 are available open access under a Creative Commons Attribution-NonCommercial 4.0 International License via link.springer.com.

Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2013

Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2013
Hearings Before a Subcommittee of the Committee on Appropriations, House of Representatives, One Hundred Twelfth Congress, Second Session

by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies

  • Publisher : Unknown Publisher
  • Release : 2012
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

Revolution

Revolution
Ice Age Re-Entry

by Carlton B. Brown

  • Publisher : Atitlan Press
  • Release : 2021
  • Pages : 329
  • ISBN : 0992775051
  • Language : En, Es, Fr & De
GET BOOK

Mitigating the Risks of a 21st Century Climate Switch (to global cooling) and Running Out of Oil and Gas: There is an urgent need to prepare the world for a 21st century climate switch to a cooling phase, and this current grand solar minimum is a prime time for that switch. The world will face natural climate change-related risks during the current grand solar minimum—risks dismissed or ignored by the Intergovernmental Panel on Climate Change (IPCC) because of its constraining Articles 1 and 2. Solar scientists expert in climate change are warning us of a 21st century global cooling, but the IPCC process has dismissed their science and that of other climate sub-disciplines. Climate-forcing volcanism, Arctic glacier expansion, rapid climate change, and the climate- and volcanic-related catastrophes that occurred during the Little Ice Age are risks that were also dismissed by the IPCC process. Earth actually entered a new Ice Age 8 and 10.5 millennia ago, in the Arctic and the Antarctic respectively. Since the Holocene Climate Optimum 8,000 years ago, Greenland’s temperature declined by 4.90C to its lowest trough in 1700. The subsequent 1700-2016 trough-to-peak temperature rise is the largest temperature increase in 8,000 years. Glacier ice accumulation also started 5,000 years ago, reaching its peak during the Little Ice Age. However, since the mid-19th century much of this glacier ice melted as the sun entered an extreme grand solar maximum phase, which human activity has exacerbated. Section 3 of this book provides best-practice strategies for implementing decentralized sustainable development and switching the world’s energy system to renewable energy. These strategies will be required to mitigate the yet unseen climate and resource supply-related risks that loom on the horizon. This book is pitched at the levels of central governments, local governments, and for you at home, and is a must if you want to know the data-driven facts about natural climate change.

Novel Immune Potentiators and Delivery Technologies for Next Generation Vaccines

Novel Immune Potentiators and Delivery Technologies for Next Generation Vaccines
A Book

by Manmohan Singh

  • Publisher : Springer Science & Business Media
  • Release : 2013-03-03
  • Pages : 370
  • ISBN : 1461453801
  • Language : En, Es, Fr & De
GET BOOK

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations—many of which will be nanoparticulates—can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.​