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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
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.
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.
Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. - Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products - Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years - Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
​Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.
Animal Cell Bioreactors provides an introduction to the underlying principles and strategies in the in vitro cell culture biotechnology. It addresses engineering aspects such as mass transfer, instrumentation, and control ensuring successful design and operation of animal cell bioreactors. The goal is to provide a comprehensive analysis and review in the advancement of the bioreactor systems for large-scale animal cell cultures. The book is organized into four parts. Part I traces the historical development of animal cell biotechnology. It presents examples of work in progress that seeks to make animal cell biotechnology processes as productive on a cost per unit of product basis as that achieved by other microbial systems. Part II includes chapters dealing with the implications of cell biology in animal cell biotechnology; protein-bound oligosaccharides and their structures; the development of serum-free media and its use in the production of biologically active substances; and the metabolism of mammalian cells. Part III focuses on animal cell cultivation, covering topics such as the fixed bed immobilized culture; three-dimensional microcarriers; and hydrodynamic phenomena in microcarrier cultures. Part IV discusses the design, operation, and control of animal cell bioreactors.
The completion of the Human Genome Project and the rapid progress in cell bi- ogy and biochemical engineering, are major forces driving the steady increase of approved biotech products, especially biopharmaceuticals, in the market. Today mammalian cell products (“products from cells”), primarily monoclonals, cytokines, recombinant glycoproteins, and, increasingly, vaccines, dominate the biopharmaceutical industry. Moreover, a small number of products consisting of in vitro cultivated cells (“cells as product”) for regenerative medicine have also been introduced in the market. Their efficient production requires comprehensive knowledge of biological as well as biochemical mammalian cell culture fundamentals (e.g., cell characteristics and metabolism, cell line establishment, culture medium optimization) and related engineering principles (e.g., bioreactor design, process scale-up and optimization). In addition, new developments focusing on cell line development, animal-free c- ture media, disposables and the implications of changing processes (multi-purpo- facilities) have to be taken into account. While a number of excellent books treating the basic methods and applications of mammalian cell culture technology have been published, only little attention has been afforded to their engineering aspects. The aim of this book is to make a contribution to closing this gap; it particularly focuses on the interactions between biological and biochemical and engineering principles in processes derived from cell cultures. It is not intended to give a c- prehensive overview of the literature. This has been done extensively elsewhere.
Access Your Prophetic Advantage in Prayer! What is really happening in the unseen realm when we pray in tongues? In Tongues of Fire, seasoned prophetic teacher and prayer leader, Jennifer LeClaire offers fresh biblical insight into what goes on when we activate our heavenly prayer language. Using directed prayer activations, Jennifer helps you tap into the power of praying in tongues. She examines the physiological effects that praying in tongues has on our bodies as well as the promises of God we access when we pray. Divided into 101 easy to read mini-chapters, you will discover how to: Break Religious Mindsets Strengthen Your Physical Body Tap into Heaven's Revelation and Mysteries Receive Holy Boldness Open Your Seer Eyes to the Unseen Realm Shift Spiritual Atmospheres Pray Perfect Prayers Don't get stuck in a rut of powerless prayer. There’s a whole realm of glory and power awaiting you as you unlock the mysteries of praying in tongues. Tap into it today and see your life transformed from the inside out!
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.