Download or read book Bioprocessing of Viral Vaccines written by Amine Kamen and published by CRC Press. This book was released on 2022-09-06 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.
Download or read book Bioreactor Design Concepts for Viral Vaccine Production written by Surajbhan Sevda and published by Elsevier. This book was released on 2024-05-12 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioreactor Design Concepts for Viral Vaccine Production covers a range of interdisciplinary chapters from the engineering perspective of bioreactor design to the biotechnological perspectives of vector design for vaccine development. The book covers bioreactor concepts such as static systems, single-use systems, stirred tanks, perfusion, wave and packed-beds. It reviews options for efficient and economical production of human vaccines and discusses basic factors relevant for viral antigen production in mammalian cells, avian cells, and insect cells. This book will be a great resource for those interested in implemented novel bioreactor design or experimental schemes towards intensified or/and enhanced vaccine production. Covers the fundamentals of bioreactor designs Provides strategies for designing a successful vector-based vaccine Discusses the applications of biological kinetics, thermodynamics and basic substrate requirements for viral vaccine production
Download or read book Opportunities in Biotechnology for Future Army Applications written by National Research Council and published by National Academies Press. This book was released on 2001-07-11 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report surveys opportunities for future Army applications in biotechnology, including sensors, electronics and computers, materials, logistics, and medical therapeutics, by matching commercial trends and developments with enduring Army requirements. Several biotechnology areas are identified as important for the Army to exploit, either by direct funding of research or by indirect influence of commercial sources, to achieve significant gains in combat effectiveness before 2025.
Download or read book Vaccine Development and Manufacturing written by Emily P. Wen and published by John Wiley & Sons. This book was released on 2014-10-06 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 Bioprocess Development for Plasmid based Vaccine Production written by Clarence Ongkudon and published by . This book was released on 2011 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plasmid DNA (pDNA) vaccine is a promising vaccine technology, with better safety profile, more economical production and transport logistics, than conventional viral vaccines. Most importantly, pDNA vaccines elicit different immune responses including antibody-mediated, CD4 T-cell-mediated and CD8 T-cell-mediated immune responses, for defending against viral infections and cancer. The increasing number of preclinical and clinical trials on plasmid vaccines has triggered the need to make more in less time. Recent developments in theproduction of plasmid therapeutics involve the establishment of innovative and cost effective methods as well as simplified operations. This dissertation reports fundamental studies essential to the development of a rapid economically-viable plasmid production system which is cGMP-compatible. Optimisation of upstream bacterial fermentation and continuousdownstream purification of the plasmid vaccine fraction are the main aspects considered in the project of this dissertation. Process variables required to improve the volumetric and specific yields of a model plasmid-based measles vaccine (pcDNA3F) harboured in E. coli DH5[alpha] were investigated. A cGMP-compatible method offering the capacity to continuouslyproduce homogeneous supercoiled pDNA from clarified bacterial lysate using a monolithicadsorbent was developed. The method involved optimisation of the adsorbent characteristics, ligand functionalisation and chromatographic process conditions. The feasibility of using free metal ions to preferentially precipitate endotoxins (LPS) from a clarified plasmid DNAcontainingbacterial lysate was investigated. Screening of various free metal ions for effectiveendotoxin removal and optimisation of process conditions, such as pH, ion concentration, temperature and incubation time, using central composite design experiments were performed. The potential and advantages of using Zn2+-induced LPS aggregation as a secondary pDNA purification method was validated by studying the interaction of Zn2+ with LPS and pDNA. A comparative economic analysis on the basis of vaccine cost per dose for influenza vaccine produced via pDNA vaccine technology and fertilised egg-based technology was also studied. Experimental results from growth medium optimisation in 500 mL culture showed a maximum volumetric yield of 13.65 mg/L, twice the amount generated using a standard medium (PDM). Fed-batch fermentation in combination with exponential glycerol feeding strategy resulted in a significant increase of 110 mg/L pcDNA3F volumetricyield and a specific yield of 14 mg/g. In addition, growth pH variation (6 to 8.5) andtemperature fluctuation (35 oC to 45 oC) also resulted in improved plasmid yield.Chromatographic purification of pDNA using a triethylamine-activated conical monolithicadsorbent resulted in preferential pcDNA3F adsorption with optimum resolution achievedunder the conditions of 400 nm pore size of monolith, 0.7 M NaCl (pH 6) of binding bufferand 3 % B/min of gradient elution up to 1 M NaCl. Plasmid volumetric yield and recovery of ~3g/L and ~90% were obtained. Contaminant levels recorded were protein (0.01 mg/L), LPS(0.12 EU/mg) with no detectable gDNA and RNA. Results from endotoxin removal andanalysis showed that ZnSO4 displayed the highest endotoxin removal efficiency (~91%) and plasmid recovery (~100%). It was found that selective endotoxin precipitation ( 0.05 EU/Mg) could effectively be carried out during neutralisation in alkaline cell lysis at a pH condition similar to that of clarified cell lysate, a low ZnSO4 concentration (0.5 M), a minimum incubation time (30 min) and a temperature of 15 oC. Apparently, the lipopolysaccharide (LPS) showed a decreased aggregate size at the start of the ZnSO4 addition before increasing gradually. Results from the LPS aggregation analysis drew a hypothesis thatcationic close range encounter and interaction with LPS monomers may contribute to LPS self-aggregation whilst bridging of LPS monomers may increase the LPS aggregate size to a greater extent compared to that of self-aggregation. Specifically, addition of Zn2+ resulted in the largest number of LPS particles per aggregate and the value of aggregation constant (Km)for LPS-Zn2+ was substantially low (0.28 M) and considerably large (2 M) for pDNA-Zn2+,indicating its preferential ability to remove LPS from pDNA-containing solutions. The economic studies suggested that pDNA-based influenza vaccine production was highly dependent on the selling price and production volume. A similar cost per dose of about $2 was calculated although most of the manufacturing costs for plasmid DNA vaccine were lower than inactivated virus vaccine. This dissertation has developed a simple bioprocess framework to successfully improve production specification of plasmid vaccines using pcDNA3F as a model. The method offers ease of plasmid DNA purification due to reduced bulk impurities, cost-efficiency and most importantly high endotoxin removal (> 80%) and plasmid recovery (> 90% ). The technology will have a great impact on overall plasmidproduction and in particular on the development of axial flow monolithic purification in combination with selective endotoxin precipitation.
Download or read book Adenoviral Vectors for Gene Therapy written by David T. Curiel and published by Academic Press. This book was released on 2016-03-10 with total page 870 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adenoviral Vectors for Gene Therapy, Second Edition provides detailed, comprehensive coverage of the gene delivery vehicles that are based on the adenovirus that is emerging as an important tool in gene therapy. These exciting new therapeutic agents have great potential for the treatment of disease, making gene therapy a fast-growing field for research. This book presents topics ranging from the basic biology of adenoviruses, through the construction and purification of adenoviral vectors, cutting-edge vectorology, and the use of adenoviral vectors in preclinical animal models, with final consideration of the regulatory issues surrounding human clinical gene therapy trials. This broad scope of information provides a solid overview of the field, allowing the reader to gain a complete understanding of the development and use of adenoviral vectors. Provides complete coverage of the basic biology of adenoviruses, as well as their construction, propagation, and purification of adenoviral vectors Introduces common strategies for the development of adenoviral vectors, along with cutting-edge methods for their improvement Demonstrates noninvasive imaging of adenovirus-mediated gene transfer Discusses utility of adenoviral vectors in animal disease models Considers Federal Drug Administration regulations for human clinical trials
Download or read book Animal Cell Biotechnology written by Ralf Pörtner and published by Humana. This book was released on 2016-08-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal Cell Biotechnology: Methods and Protocols, Third Edition constitutes a comprehensive manual of state-of-the-art and new techniques for setting up mammalian cell lines for production of biopharmaceuticals, and for optimizing critical parameters for cell culture from lab to final production. The volume is divided into five parts that reflect the processes required for different stages of production. In Part I, basic techniques for establishment of production cell lines are addressed, especially high-throughput synchronization, insect cell lines, transient gene and protein expression, DNA Profiling and Characterisation. Part II addresses tools for process and medium optimization as well as microcarrier technology while Part III covers monitoring of cell growth, viability and apoptosis, metabolic flux estimation, quenching methods as well as NMR-based techniques. Part IV details cultivation techniques, and Part V describes special applications, including vaccine production, baculovirus protein expression, chromatographic techniques for downstream as well as membrane techniques for virus separation. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Animal Cell Biotechnology: Methods and Protocols, Third Edition provides a compendium of techniques for scientists in industrial and research laboratories that use mammalian cells for biotechnology purposes.
Download or read book Biological Threats and Terrorism written by Institute of Medicine and published by National Academies Press. This book was released on 2002-03-07 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.
Download or read book Putting Biotechnology to Work written by National Research Council and published by National Academies Press. This book was released on 1992-02-01 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ability of the United States to sustain a dominant global position in biotechnology lies in maintaining its primacy in basic life-science research and developing a strong resource base for bioprocess engineering and bioproduct manufacturing. This book examines the status of bioprocessing and biotechnology in the United States; current bioprocess technology, products, and opportunities; and challenges of the future and what must be done to meet those challenges. It gives recommendations for action to provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer.
Download or read book Industrial Scale Suspension Culture of Living Cells written by Hans-Peter Meyer and published by John Wiley & Sons. This book was released on 2014-08-04 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: The submersed cultivation of organisms in sterile containments or fermenters has become the standard manufacturing procedure, and will remain the gold standard for some time to come. This book thus addresses submersed cell culture and fermentation and its importance for the manufacturing industry. It goes beyond expression systems and integrally investigates all those factors relevant for manufacturing using suspension cultures. In so doing, the contributions cover all industrial cultivation methods in a comprehensive and comparative manner, with most of the authors coming from the industry itself. Depending on the maturity of the technology, the chapters address in turn the expression system, basic process design, key factors affecting process economics, plant and bioreactor design, and regulatory aspects.
Download or read book Biological Safety written by Dawn P. Wooley and published by John Wiley & Sons. This book was released on 2017-02-01 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.
Download or read book Viral Nanoparticles written by Nicole F. Steinmetz and published by CRC Press. This book was released on 2019-08-21 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book overviews the applications of viral nanoparticles (VNPs) in areas ranging from materials science to biomedicine. It summarizes the many different VNP building blocks and describes chemistries that allow one to attach, entrap, or display functionalities on VNPs. The book outlines the strategies for the construction of 1-, 2-, and 3-D arrays, highlights the achievements in utilizing VNPs as tools for novel biosensors and nanoelectronic devices, and describes efforts in designing VNPs for biomedical applications, including their use as gene delivery vectors, novel vaccines, imaging modalities, and applications in targeted therapeutics.
Download or read book The Application of Viruses to Biotechnology written by Carla Varanda and published by Mdpi AG. This book was released on 2021-12-21 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Viruses are microscopic agents that exist worldwide and are present in humans, animals, plants, and other living organisms in which they can cause devastating diseases. However, the advances of biotechnology and next-generation sequencing technologies have accelerated novel virus discovery, identification, sequencing, and manipulation, showing that they present unique characteristics that place them as valuable tools for a wide variety of biotechnological applications. Many applications of viruses have been used for agricultural purposes, namely concerning plant breeding and plant protection. Nevertheless, it is interesting to mention that plants have also many advantages to be used in vaccine production, such as the low cost and low risks they entail, showing once more the versatility of the use of viruses in biotechnology. Although it will obviously never be ignored that viruses are responsible for devastating diseases, it is clear that the more they are studied, the more possibilities they offer to us. They are now on the front line of the most revolutionizing techniques in several fields, providing advances that would not be possible without their existence. In this book there are presented studies that demonstrate the work developed using viruses in biotechnology. These studies were brought by experts that focus on the development and applications of many viruses in several fields, such as agriculture, the pharmaceutical industry, and medicine.
Download or read book Bioprocess and Analytics Development for Virus based Advanced Therapeutics and Medicinal Products ATMPs written by Saurabh Gautam and published by Springer Nature. This book was released on 2023-08-10 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control. The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.
Download or read book Viral Vectors in Veterinary Vaccine Development written by Thiru Vanniasinkam and published by Springer Nature. This book was released on 2020-11-30 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly accessible textbook introduces readers to the development of viral vectors and discusses their application in veterinary vaccinology. It offers comprehensive information on the latest advances in this emerging research field, together with a broad overview of the history of veterinary vaccines and viral vectors. The book also addresses issues concerning funding, translational research and ethics that will impact the future development, manufacture and global use of viral vector-based veterinary vaccines. The book addresses the needs of graduate students and researchers in the fields of Veterinary Medicine, Virology and Immunology.
Download or read book Genetically Engineered Plants as a Source of Vaccines Against Wide Spread Diseases written by Sergio Rosales-Mendoza and published by Springer. This book was released on 2016-09-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetically Engineered Plants as a Source of Vaccines Against Wide Spread Diseases: An Integrated View provides an integrated outlook of the disciplines involved in the development of plant-based vaccines as well as an updated compilation of the successful developments in the field. The volume covers immunological aspects of mucosal vaccine design, molecular approaches to attain high levels of the recombinant antigens, the rationale of using bioreactor to expand plant biomass, and pharmaceutical technology approaches that have been applied to the development of plant-based vaccine formulations. Practical figures and tables are presented to facilitate reading and identification of key points. Perspectives for this field are also discussed. Written by authorities in the field, Genetically Engineered Plants as a Source of Vaccines Against Wide Spread Diseases: An Integrated View is a comprehensive resource for researchers and students interested in plant genetics and breeding, immunology, and genetic engineering.
Download or read book Biotechnology for Beginners written by Reinhard Renneberg and published by Academic Press. This book was released on 2023-01-16 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology for Beginners, Third Edition presents the latest developments in the evolving field of biotechnology which has grown to such an extent over the past few years that increasing numbers of professional’s work in areas that are directly impacted by the science. This book offers an exciting and colorful overview of biotechnology for professionals and students in a wide array of the life sciences, including genetics, immunology, biochemistry, agronomy and animal science. This book will also appeals to lay readers who do not have a scientific background but are interested in an entertaining and informative introduction to the key aspects of biotechnology. Authors Renneberg and Loroch discuss the opportunities and risks of individual technologies and provide historical data in easy-to-reference boxes, highlighting key topics. The book covers all major aspects of the field, from food biotechnology to enzymes, genetic engineering, viruses, antibodies, and vaccines, to environmental biotechnology, transgenic animals, analytical biotechnology, and the human genome. Covers the whole of biotechnology Presents an extremely accessible style, including lavish and humorous illustrations throughout Includes new chapters on CRISPR cas-9, COVID-19, the biotechnology of cancer, and more
