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The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?
Natural Products, broadly defined as high value chemical entities derived from plants or microbial sources, have been known and exploited for many years. In recent years, as the need for higher potency and predictability of such products has increased, more sophisticated concentration and isolation procedures have been developed. With the passage of time, such procedures have been rationalized in terms of scientific principles but, in general, theory has followed behind practice, leading at any given time to an absence from the literature of methods which are truly state of the art. Downstream Processing of Natural Products: A Practical Handbook is a highly practical manual which addresses this issue, and guides researchers and industrial workers through the many potential pitfalls of natural product isolation. The contributors to this volume, all of whom have wide practical experience in this field, present state-of-the-art techniques and observations. The three main stages of natural product purification are covered, namely product release, capture, and purification, and both proteins and secondary metabolites are covered. There is special mention of the requirements of the regulatory authorities with respect to Good Manufacturing Practice, and practical guidance is given on scale-up procedures and process scale instrumentation. Downstream Processing of Natural Products: A Practical Handbook will provide essential practical guidance to all those involved in natural product isolation. This includes academic and industrial researchers, postgraduate students and technicians working in the biotechnology field.
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design
An all-in-one practical guide on how to efficiently use chromatographic separation methods Based on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstream Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization. -Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies -Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions -Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries -Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S. Protein Chromatography: Process Development and Scale-Up, Second Edition will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
Handbook of Biofuels looks at the many new developments in various type of bioenergy, along with the significant constraints in their production and/or applications. Beyond introducing current approaches and possible future directions of research, this title covers sources and processing of raw materials to downstream processing, constraints involved and research approaches to address and overcome these needs. Different combinations of products from the biorefinery are included, along with the material to answer questions surrounding the optimum process conditions for conversion of different feedstocks to bioenergy, the basis for choosing conversion technology, and what bioenergy products make economic sense. With chapters on the techno-economic analysis of biofuel production and concepts and step-by-step approaches in bioenergy processing, the objective of this book is to present a comprehensive and all-encompassing reference about bioenergy to students, teachers, researchers and professionals. - Reviews all existing and emerging technologies surrounding the production of advanced biofuels, including biodiesel and bioethanol - Includes biofuel applications with compatible global application case studies - Offers new pathways for converting biomass
Proteins are important biomolecules that are vital for the cellular structure and function. They perform a vast array of functions within organisms, including the catalysis of metabolic reactions, DNA replication, response to stimuli, and transporting molecules from one location to another. The technological advances in the omics areas (e.g., genomics, transcriptomics, proteomics, metagenomics, etc.) have dramatically increased the rate of discovering new proteins. Some of them hold large opportunities for innovative research and the development of commercial products and applications. It is worth noting that the global protein ingredients market is poised to grow over the next decade to reach approximately 58.49 billion USD by 2022, with the protein therapeutics market valuing around USD 315.9 billion by 2025. Interestingly, about seventy monoclonal antibody products will be on the market by 2020 with a combined worldwide sales of about 125 billion USD.The most significant parameter for the successful commercial exploitation of proteins rely on the development of an efficient and effective isolation and purification technology, known as protein downstream processing. Downstream processing refers to the technology that involves the isolation and production of purified products from natural sources such as animal tissues, plant tissues, microorganisms or fermentation broth. The most important element of this technology is the high purification processes, most important of which is chromatography and in particular affinity chromatography.This book provides information on the resent developments of protein downstream processing and deals with the information gained over the last years from the application of protein purification technologies on different research areas. Each chapter gives key examples that cover a wide range of diverse scientific disciplines in order to provide the reader with a representative sample of the current status of the field. The present book would definitely be an ideal source of scientific information to the advanced students, junior researchers, and scientists involved in cellular and molecular biology, biochemistry, microbiology, biotechnology and other related areas.
This book covers all aspects of physical vapor deposition (PVD) process technology from the characterizing and preparing the substrate material, through deposition processing and film characterization, to post-deposition processing. The emphasis of the book is on the aspects of the process flow that are critical to economical deposition of films that can meet the required performance specifications. The book covers subjects seldom treated in the literature: substrate characterization, adhesion, cleaning and the processing. The book also covers the widely discussed subjects of vacuum technology and the fundamentals of individual deposition processes. However, the author uniquely relates these topics to the practical issues that arise in PVD processing, such as contamination control and film growth effects, which are also rarely discussed in the literature. In bringing these subjects together in one book, the reader can understand the interrelationship between various aspects of the film deposition processing and the resulting film properties. The author draws upon his long experience with developing PVD processes and troubleshooting the processes in the manufacturing environment, to provide useful hints for not only avoiding problems, but also for solving problems when they arise. He uses actual experiences, called ""war stories"", to emphasize certain points. Special formatting of the text allows a reader who is already knowledgeable in the subject to scan through a section and find discussions that are of particular interest. The author has tried to make the subject index as useful as possible so that the reader can rapidly go to sections of particular interest. Extensive references allow the reader to pursue subjects in greater detail if desired. The book is intended to be both an introduction for those who are new to the field and a valuable resource to those already in the field. The discussion of transferring technology between R&D and manufacturing provided in Appendix 1, will be of special interest to the manager or engineer responsible for moving a PVD product and process from R&D into production. Appendix 2 has an extensive listing of periodical publications and professional societies that relate to PVD processing. The extensive Glossary of Terms and Acronyms provided in Appendix 3 will be of particular use to students and to those not fully conversant with the terminology of PVD processing or with the English language.
A unique, well-documented, and forward-thinking work, the second edition of Handbook of Natural Gas Transmission and Processing continues to present a thoroughly updated, authoritative, and comprehensive description of all major aspects of natural gas transmission and processing. It provides an ideal platform for engineers, technologists, and operations personnel working in the natural gas industry to get a better understanding of any special requirements for optimal design and operations of natural gas transmission pipelines and processing plants. First book of its kind that covers all aspects of natural gas transmission and processing Provides pivotal updates on the latest technologies, which have not been addressed in-depth in any existing books Offers practical advice for design and operation based on sound engineering principles and established techniques Examines ways to select the best processing route for optimal design of gas-processing plants Contains new discussions on process modeling, control, and optimization in gas processing industry
Handbook of Microalgal Culture is truly a landmarkpublication, drawing on some 50 years of worldwide experience inmicroalgal mass culture. This important book comprisescomprehensive reviews of the current available information onmicroalgal culture, written by 40 contributing authors from aroundthe globe. The book is divided into four parts, with Part I detailingbiological and environmental aspects of microalgae with referenceto microalgal biotechnology and Part II looking in depth at majortheories and techniques of mass cultivation. Part III compriseschapters on the economic applications of microalgae, includingcoverage of industrial production, the use of microalgae in humanand animal nutrition and in aquaculture, in nitrogen fixation,hydrogen and methane production, and in bioremediation of pollutedwater. Finally, Part IV looks at new frontiers and includeschapters on genetic engineering, microalgae as platforms forrecombinant proteins, bioactive chemicals, heterotrophicproduction, microalgae as gene-delivery systems for expressingmosquitocidal toxins and the enhancement of marine productivity forclimate stabilization and food security. Handbook of Microalgal Culture is an essential purchasefor all phycologists and also those researching aquatic systems,aquaculture and plant sciences. There is also much of great use toresearchers and those involved in product formulation withinpharmaceutical, nutrition and food companies. Libraries in alluniversities and research establishments teaching and researchingin chemistry, biological and pharmaceutical sciences, food sciencesand nutrition, and aquaculture will need copies of this book ontheir shelves. Amos Richmond is at the Blaustein Institute for DesertResearch, Ben-Gurion University of the Negev, Israel.