Biotechnology and Bioprocessing – serie

From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzyme kinetics for successful applications of biocatalysis and bioprocess technologies in the food, chiral drug, vitamin, pharmaceutical, and animal feed industries. Studying reactions from small to supramolecules, this reference provides an abundant supply of end-of-chapter problems to sharpen understanding of key concepts presented in the text.

Offers coverage of the development of protein purification processes for large-scale commercial operations, and addresses process development, scale-up, applications and mathematical descriptions. Technologies currently used at the commercial scale are covered in depth.

Consolidating and expanding current, fundamental notions of virology and animal cell cultivation, this practical reference examines the development of insect cell culture techniques for the production of recombinant proteins and insect pathogenic viruses.;Resolving on-the-job problems such as sparging cell damage and reduced infectivity cells, Insect Cell Culture Engineering: includes special introductory material as well as background information on insect pathogenic viruses, the molecular biology of baculoviruses and bioreactor design; offers advice on how to save time when deciding which insect cell line, bioreactor and medium to exploit; discusses the preparation of mathematical modelling in animal cell culture; addresses the concerns associated with insect cell immobilization and the use of serum-free culture media; provides insights into the protective effects of polymer additives and insect cell gene expression in pharmaceutical research; and analyzes process scale-up and reactor design.;Bridging the gap between laboratory research and pilot plant scale insect culture/baculovirus technology, Insect Cell Culture Engineering is designed as a reference for biochemical and bioprocess engineers, bioprocess technologists, biochemists, molecular and cell biologists, microbiologists, and upper-level undergraduate and graduate students in these disciplines.

Contributors from European and US universities and corporations review recent developments in the integration of downstream processing and bioconversion, describing their experience with many separation technologies, including some still in the experimental stage. The topics include the construction

Fills a gap between the existing studies of proteins, which tend to be highly technical and geared toward the practicing protein chemist, and biochemistry textbooks, which focus on general principles. Scientists cover a dozen topics by presenting fundamental principles, an overview, and the practica

Contributors from universities and food, pharmaceutical, and brewing companies detail the current state of yeast strain development and handling, highlighting advances in yeast selection for academic research, industry, and recombinant DNA technology. Featuring the use of Saccharomyces and other yea

This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications.

Process engineering can potentially provide the means to develop economically viable and environmentally friendly technologies for the production of fuel ethanol. Focusing on a key tool of process engineering, Process Synthesis for Fuel Ethanol Production is a comprehensive guide to the design and analysis of the most advanced technologies for fuel ethanol production from feedstocks. It describes how process systems engineering can be applied to fuel ethanol production to achieve new levels of efficiency according to technical, economic, and environmental criteria.Drawing on the authors’ more than 15 years of process engineering and ethanol research, the book first focuses on liquid biofuels, before examining the role of process synthesis in the rapid and high-tech analysis and design of complex biotechnological processes. It then describes various types of feedstocks, including sugars, starchy crops, lignocellulosic biomass, and microorganisms, as well as hydrolysis technologies, such as saccharification. The authors cover the fuel ethanol production technologies for different feedstocks, the new technological innovations based on process integration to reduce energy consumption, and the environmental issues of bioethanol production. They also discuss the technological configurations for fuel ethanol production in the industry and the possible factors affecting food security with fuel ethanol production and consumption.Supported by case studies that include calculations and discussions of results, this book uses a process engineering approach to explore the analysis and development of fuel ethanol production from different feedstocks. It shows how accurate analysis and precise design, along with responsible government policies, can lead to fair and sustainable development of energy crops worldwide.

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules.Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends.Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.

The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzyme kinetics for successful applications of biocatalysis and bioprocess technologies in the food, chiral drug, vitamin, pharmaceutical, and animal feed industries. Studying reactions from small to supramolecules, this reference provides an abundant supply of end-of-chapter problems to sharpen understanding of key concepts presented in the text.

Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the importance of gene discovery and genomic technology development in the production of biotechnology products, tissue engineering, and cell-based therapies. Offering detailed guidance, they cover the steps leading up to the creation of viable therapies including host cell selection, cloning and gene amplification, bioreactor design and operation, protein purification, optimization, scale-up, and facility design.

This unique reference/text presents the basic theory and practical applications of metabolic engineering (ME). It offers systematic analysis of complex metabolic pathways and ways of employing recombinant DNA techniques to alter cell behavior, metabolic patterns, and product formation. Treating ME as a distinct subfield of genetic engineering, the book demonstrates new means of enabling cells to produce valuable proteins, polypeptides, and primary and secondary metabolites.Written by more than 35 leading international experts in the field, this book discusses metabolic engineering in plant and mammalian cells, bacteria, and yeasts and assesses metabolic engineering applications in agriculture, pharmaceuticals, and environmental systems. It illuminates the potential of the "cell factory" model for production of chemicals and therapeutics and examines methods for developing new antiviral and antibacterial molecules and effective gene and somatic-cell therapies. Metabolic Engineering also addresses the use of metabolic flux analysis, metabolic control analysis, and online metabolic flux analysis.

Edited to avoid duplication and favor comprehensiveness, 20 contributors detail the recovery, separation, and purification operations of bioprocess technology. Individual chapters in this classic yet still highly relevant work emphasize concepts that are becoming more and more important when applied to the large scale versions of techniques that are considered well established. Aside from fully discussing processes, Separation Processes in Biotechnology includes sections on concentration separation and operation, purification operations, and product release and recovery. It also discusses plant operation and equipment and delves into economic considerations

Contributors from European and US universities and corporations review recent developments in the integration of downstream processing and bioconversion, describing their experience with many separation technologies, including some still in the experimental stage. The topics include the construction

This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications.

Contributors from universities and food, pharmaceutical, and brewing companies detail the current state of yeast strain development and handling, highlighting advances in yeast selection for academic research, industry, and recombinant DNA technology. Featuring the use of Saccharomyces and other yea

An interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. The volume offers a biological perspective of large-scale animal cell culture and examines diverse processing strategies, process management, regulator

Fills a gap between the existing studies of proteins, which tend to be highly technical and geared toward the practicing protein chemist, and biochemistry textbooks, which focus on general principles. Scientists cover a dozen topics by presenting fundamental principles, an overview, and the practica

Consolidating and expanding current, fundamental notions of virology and animal cell cultivation, this practical reference examines the development of insect cell culture techniques for the production of recombinant proteins and insect pathogenic viruses.;Resolving on-the-job problems such as sparging cell damage and reduced infectivity cells, Insect Cell Culture Engineering: includes special introductory material as well as background information on insect pathogenic viruses, the molecular biology of baculoviruses and bioreactor design; offers advice on how to save time when deciding which insect cell line, bioreactor and medium to exploit; discusses the preparation of mathematical modelling in animal cell culture; addresses the concerns associated with insect cell immobilization and the use of serum-free culture media; provides insights into the protective effects of polymer additives and insect cell gene expression in pharmaceutical research; and analyzes process scale-up and reactor design.;Bridging the gap between laboratory research and pilot plant scale insect culture/baculovirus technology, Insect Cell Culture Engineering is designed as a reference for biochemical and bioprocess engineers, bioprocess technologists, biochemists, molecular and cell biologists, microbiologists, and upper-level undergraduate and graduate students in these disciplines.

Offers a detailed introduction to the fundamental phenomena that govern cell adhesion and describes bioengineering processes that employ cell adhesion, focusing on both biochemical and biomedical applications. All industrially relevant issues of cell adhesion - from basic concepts, quantitative experiments, and mathematical models to applications in bioreactors and other process equipment - are examined.

Describes the state-of-the-art techniques and methods involved in the design, operation, preparation and containment of bioreactor systems, taking into account the interrelated effects of variables associated with both upstream and downstream stages of the design process. The importance of the initial steps in the development of a bioprocess, such as strain and media selection, that have an overwhelming influence on all further operations, is emphasized.;This work is intended for biochemical, chemical and bioprocess engineers; biotechnologists; industrial biochemists; micro- and molecular biologists; food scientists; and upper-level undergraduate and graduate students in these disciplines.

Offers coverage of the development of protein purification processes for large-scale commercial operations, and addresses process development, scale-up, applications and mathematical descriptions. Technologies currently used at the commercial scale are covered in depth.

Bridging the gap between laboratory observations and industrial practices, this work presents detailed information on recombinant micro-organisms and their applications in industry and agriculture. All recombinant microbes, bacteria, yeasts and fungi are covered.

Process engineering can potentially provide the means to develop economically viable and environmentally friendly technologies for the production of fuel ethanol. Focusing on a key tool of process engineering, Process Synthesis for Fuel Ethanol Production is a comprehensive guide to the design and analysis of the most advanced technologies for fuel ethanol production from feedstocks. It describes how process systems engineering can be applied to fuel ethanol production to achieve new levels of efficiency according to technical, economic, and environmental criteria.Drawing on the authors’ more than 15 years of process engineering and ethanol research, the book first focuses on liquid biofuels, before examining the role of process synthesis in the rapid and high-tech analysis and design of complex biotechnological processes. It then describes various types of feedstocks, including sugars, starchy crops, lignocellulosic biomass, and microorganisms, as well as hydrolysis technologies, such as saccharification. The authors cover the fuel ethanol production technologies for different feedstocks, the new technological innovations based on process integration to reduce energy consumption, and the environmental issues of bioethanol production. They also discuss the technological configurations for fuel ethanol production in the industry and the possible factors affecting food security with fuel ethanol production and consumption.Supported by case studies that include calculations and discussions of results, this book uses a process engineering approach to explore the analysis and development of fuel ethanol production from different feedstocks. It shows how accurate analysis and precise design, along with responsible government policies, can lead to fair and sustainable development of energy crops worldwide.

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time.Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.