Download or read book Spray Drying of Vaccines written by Cordin Arpagaus and published by Springer Nature. This book was released on 2023-04-03 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the stabilization of vaccine powders by spray drying and provides an overview of the current state of the art on a laboratory and industrial scale. The book aims to familiarize readers with the advances in vaccine spray drying technology to understand its application potential better. In particular, the book addresses the design of aseptic spray dryers, parameters affecting the spray drying process, sterile powder processing, cleaning procedures, and powder filling. In addition, different drying technologies for the production of dry powder vaccines are compared to discuss the unique capabilities of spray drying as a particle technology for vaccines. Special attention is given to research studies on spray-dried vaccines published over the past 30 years, with key findings from laboratory research to clinical trials. Potential applications of spray-dried vaccines and routes of administration are presented in detail. Finally, an outlook is given on how close the aseptic spray-drying of vaccines is to the market and the challenges that need to be overcome to be commercially successful. The book's target audience is academics, researchers, vaccine developers, industry experts, students, and possibly funders, including government agencies, who are active in the field. In addition, the book is a reference source for those involved in the vaccine formulation and biopharmaceutical processing industry.
Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Download or read book Lyophilized Biologics and Vaccines written by Dushyant Varshney and published by Springer. This book was released on 2015-05-19 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Micro and Nanotechnology in Vaccine Development written by Mariusz Skwarczynski and published by William Andrew. This book was released on 2016-09-20 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of how use of micro- and nanotechnology (MNT) has allowed major new advance in vaccine development research, and the challenges that immunologists face in making further progress. MNT allows the creation of particles that exploit the inherent ability of the human immune system to recognize small particles such as viruses and toxins. In combination with minimal protective epitope design, this permits the creation of immunogenic particles that stimulate a response against the targeted pathogen. The finely tuned response of the human immune system to small particles makes it unsurprising that many of the lead adjuvants and vaccine delivery systems currently under investigation are based on nanoparticles. - Provides a comprehensive and unparalleled overview of the role of micro- and nanotechnology in vaccine development - Allows researchers to quickly familiarize themselves with the broad spectrum of vaccines and how micro- and nanotechnologies are applied to their development - Includes a combination of overview chapters setting out general principles, and focused content dealing with specific vaccines, making it useful to readers from a variety of disciplines
Download or read book Comprehensive Biotechnology written by and published by Elsevier. This book was released on 2019-07-17 with total page 4876 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science
Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies
Download or read book Spray Freeze Drying of Foods and Bioproducts written by S. Padma Ishwarya and published by CRC Press. This book was released on 2022-04-19 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.
Download or read book Pharmaceutical Inhalation Aerosol Technology Third Edition written by Anthony J. Hickey and published by CRC Press. This book was released on 2019-03-26 with total page 731 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines written by Darren R. Flower and published by Springer Science & Business Media. This book was released on 2012-12-09 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Mucosal Vaccines written by Pamela A. Kozlowski and published by Springer Science & Business Media. This book was released on 2012-01-10 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is focused on the development of vaccines which generate immune effectors capable of blocking mucosal entry or peripheral pathogen spread. A critical first step in the design of mucosal vaccines is the selection of administration route. Not all mucosal immunization routes are created equally when it comes to eliciting immune responses in multiple body compartments. This subject and situations when a mucosal route may not be required for vaccine delivery are reviewed here with an emphasis on the sublingual immunization route, which may offer a safer alternative to the nasal route for induction of broadly disseminated immune responses. External host defenses that inhibit entry of microorganisms at mucosal surfaces also pose obstacles to the efficient internalization of mucosally-applied vaccines. Transcutaneous immunization with appropriate adjuvants and permeation enhancers can induce mucosal immune responses and may be advantageous for bypassing these luminal barriers. Other chapters describe strategies for enhancing uptake of mucosal vaccines, for instance through targeted delivery to antigen-sampling M cells, construction of virus-like particles which mimic natural pathogens, addition of mucoadhesives or formulation as nanoparticles. Topics include edible vaccines as well as plant-based production of subunit or particulate vaccines that could be administered by any route. Dry powder vaccines that could be insufflated or directly applied to mucosal surfaces may be particularly ideal for mass vaccination in developing countries. The manufacture, stability and efficacy of powder formulations is comprehensively reviewed. We conclude with chapters on two of the greatest challenges facing mucosal vaccine development: human immunodeficiency virus and bioterrorist agents. This monograph highlights progress and information that should prove invaluable for the development of contemporary vaccines that prevent infection by these and other mucosal pathogens.
Download or read book Vaccine Development written by A Krishna Prasad and published by Royal Society of Chemistry. This book was released on 2022-11-09 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccine development is a complex and time consuming process that differs from the development of conventional pharmaceuticals. Primarily, vaccines are intended for use in healthy individuals as a preventative measure, requiring a long and rigorous process of research and many years of testing and development prior to clinical trials and regulatory approval. The average time for the development of vaccines to clinical is 12 to 15 years. Vaccine Development: From Concept to Clinic is a detailed overview of the development of new vaccines, covering the entire process and addresses all classes of vaccines from a processing, development and regulatory viewpoint. Utilising successful case studies the book will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development. This book is an ideal companion for any researchers working in vaccine discovery and development or with an interest in the field.
Download or read book Bacterial Extracellular Vesicles written by Steven Jay and published by Springer Nature. This book was released on with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Vaccine Development From Concept to Clinic written by A. Krishna Prasad and published by Royal Society of Chemistry. This book was released on 2022-11-09 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Utilising successful case studies Vaccine Development will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development.
Download or read book Vaccine Development and Manufacturing written by Emily P. Wen and published by John Wiley & Sons. This book was released on 2014-11-17 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Organ Specific Drug Delivery and Targeting to the Lungs written by Ajit S. Narang and published by CRC Press. This book was released on 2022-11-23 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organ Specific Drug Delivery and Targeting to the Lungs provides up to date information on the multidisciplinary field of particle engineering and drug delivery to the lungs, including advancements of nanotechnology. The text presents a unique, pragmatic focus with case studies, that help translate scientific understanding to practical implementation. In addition to highlighting the successful case studies, it also offers practical advice on watchouts, limitations, and ‘bookend’ boundaries involved in the stages of testing and development. Additional Features Include: Provides an account of particle engineering, discovery, biology, development, and delivery in relation with the advancements of nanotechnology, unlike any previous book. Brings together the leading experts and researchers in the field to critically assess and discuss various topics influencing drug delivery. Highlights the interplay of different scientific disciplines and the balance of requirements that are critical to molecule and product design. With the strategic focus on what matters during new product development, this book provides a guide to understanding and navigating new drug discovery and development for lung targets.
Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-03 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Download or read book Molecular Vaccines written by Matthias Giese and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title discusses all aspects of non-infectious and non-cancer– so called NINC – vaccines. Hypertension, diabetes and allergy vaccine development are referred to as well as the use of adjuvants and nanotechnology in vaccine development. The way of novel vaccines from bench to preclinical to clinical studies and launch to the market under EMEA (European Medicines Agency) and FDA (Food and Drug Administration) guidelines are described in-depth. The book is therefore of interest for researchers and clinicians engaged in vaccine development and molecular vaccine application.
