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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 : Satoshi Ohtake,Parag Kolhe
Publisher : Academic Press
Release : 2020-12-01
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

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.

Biological Drug Products

Biological Drug Products Book
Author : Wei Wang,Manmohan Singh
Publisher : John Wiley & Sons
Release : 2013-08-29
ISBN : 1118695224
Language : En, Es, Fr & De

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Book Description :

Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2019-08-08
ISBN : 042957472X
Language : En, Es, Fr & De

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Book Description :

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

Vaccinology

Vaccinology Book
Author : Gregg N. Milligan,Alan D. T. Barrett
Publisher : John Wiley & Sons
Release : 2014-12-04
ISBN : 111863652X
Language : En, Es, Fr & De

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Book Description :

Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2014-12-03
ISBN : 3527673709
Language : En, Es, Fr & De

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Book Description :

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

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.

Development of Novel Vaccines

Development of Novel Vaccines Book
Author : Alexander von Gabain,Christoph Klade
Publisher : Springer Science & Business Media
Release : 2012-04-23
ISBN : 3709107091
Language : En, Es, Fr & De

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Book Description :

“Development of novel vaccines” gives an overview of the tasks in basic research leading to the final product – the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Book
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release : 2014-05-02
ISBN : 1118874080
Language : En, Es, Fr & De

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Book Description :

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Influenza Vaccine Federal Investments in Alternative Technologies and Challenges to Development and Licensure

Influenza Vaccine  Federal Investments in Alternative Technologies and Challenges to Development and Licensure Book
Author : Marcia Crosse
Publisher : DIANE Publishing
Release : 2011-10-07
ISBN : 1437988296
Language : En, Es, Fr & De

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Book Description :

Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Dept. of Health and Human Services (HHS) and the Dept. of Defense (DOD) support the development of technologies that can be used in producing technologies that can be used in producing influenza vaccines. HHS's Food and Drug Admin. (FDA) reviews licensing applications for new vaccine, and the Dept. of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. This report examines (1) federal funding from FY 2005 through March 2011 for alternative technologies and the status of manufacturers' efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. Tables and figures. This is a print on demand report.

Novel Technologies for Vaccine Development

Novel Technologies for Vaccine Development Book
Author : Igor S Lukashevich,Haval Shirwan
Publisher : Springer
Release : 2014-11-13
ISBN : 3709118182
Language : En, Es, Fr & De

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Book Description :

This book presents a detailed overview of the development of new viral vector-based vaccines before discussing two major applications: preventive vaccines for infectious diseases and therapeutic cancer vaccines. Viral vector-based vaccines hold a great potential for development into successful pharmaceutical products and several examples at the advanced pre-clinical or clinical stage are presented. Nevertheless, the most efforts were focused on novel and very innovative technologies for new generation of vector-based vaccines. Furthermore, specific topics such as delivery and adjuvant and protection strategies for cell-mediated-based vaccines are presented. Given its scope, the book is a “must read” for all those involved in vaccine development, both in academia and industrial vaccine development.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-08-09
ISBN : 0470118121
Language : En, Es, Fr & De

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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.

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.

Vaccine Analysis Strategies Principles and Control

Vaccine Analysis  Strategies  Principles  and Control Book
Author : Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin
Publisher : Springer
Release : 2014-11-27
ISBN : 3662450240
Language : En, Es, Fr & De

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Book Description :

This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.

Science

Science Book
Author : John Michels
Publisher :
Release : 2001-02
ISBN :
Language : En, Es, Fr & De

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Book Description :

Drugs Advances in Research and Application 2011 Edition

Drugs  Advances in Research and Application  2011 Edition Book
Author : N.A
Publisher : ScholarlyEditions
Release : 2012-01-09
ISBN : 1464920923
Language : En, Es, Fr & De

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Book Description :

Drugs: Advances in Research and Application: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Trials. The editors have built Drugs: Advances in Research and Application: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Trials in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Drugs: Advances in Research and Application: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

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 Book
Author : Allam Ahmed
Publisher : Routledge
Release : 2009
ISBN :
Language : En, Es, Fr & De

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Book Description :

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

Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines

Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines Book
Author : Darren R. Flower,Yvonne Perrie
Publisher : Springer Science & Business Media
Release : 2012-12-09
ISBN : 1461450705
Language : En, Es, Fr & De

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Book Description :

This volume will address an important emergent area within the field of immunomics: the discovery of antigens and adjuvants within the context of reverse vaccinology. Conventional approaches to vaccine design and development requires pathogens to be cultivated in the laboratory and the immunogenic molecules within them to be identifiable. Conventional vaccinology is no longer universally successful, particularly for recalcitrant pathogens. By using genomic information we can study vaccine development in silico: 'reverse vaccinology', can identify candidate subunits vaccines by identifying antigenic proteins and by using equally rational approaches to identify novel immune response-enhancing adjuvants.