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.

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.

Describing the scientific and commercial applications of microbial recombinant DNA technology, this outstanding, single-source reference offers state-of-the-art reviews of gene expression in the most important classes of recombinant microorganisms-providing numerous examples of the expression of homologous genes or heterologous gene products. Presents a unique collection of safety and regulatory considerations from around the world and addresses specific measures to be taken for large-scale industrial operations!

Of major economic, environmental and social importance, industrialmicrobiology involves the utilization of microorganisms in theproduction of a wide range of products, including enzymes, foods,beverages, chemical feedstocks, fuels and pharmaceuticals, andclean technologies employed for waste treatment and pollutioncontrol. Aimed at undergraduates studying the applied aspects of biology,particularly those on biotechnology and microbiology courses andstudents of food science and biochemical engineering, this textprovides a wide-ranging introduction to the field of industrialmicrobiology. The content is divided into three sections: key aspects of microbial physiology, exploring the versatilityof microorganisms, their diverse metabolic activities andproducts industrial microorganisms and the technology required forlarge-scale cultivation and isolation of fermentationproducts investigation of a wide range of established and novelindustrial fermentation processes and products Written by experienced lecturers with industrial backgrounds,Industrial Microbiology provides the reader with groundwork in boththe fundamental principles of microbial biology and the varioustraditional and novel applications of microorganisms to industrialprocesses, many of which have been made possible or enhanced byrecent developments in genetic engineering technology. A wide-ranging introduction to the field of industrialmicrobiology Based on years of teaching experience by experienced lecturerswith industrial backgrounds Explains the underlying microbiology as well as the industrialapplication. Content is divided into three sections: 1. key aspects of microbial physiology, exploring theversatility of microorganisms, their diverse metabolic activitiesand products 2. industrial microorganisms and the technology required forlarge-scale cultivation and isolation of fermentation products 3. investigation of a wide range of established and novelindustrial fermentation processes and products

This comprehensive edited book on microbial prospective discusses the innovative approaches and investigation strategies, as well as provides a broad spectrum of the cutting-edge research on the processing, properties and technological developments of microbial products and their applications. Microbes finds very important applications in our lives including industries and food processing. They are widely used in the fermentation of beverages, processing of dairy products, production of pharmaceuticals, chemicals, enzymes, proteins and biomaterials; conversion of biomass into fuel, fuel cell technology, health and environmental sectors. Some of these products are produced commercially, while others are potentially valuable in biotechnology. Microorganisms are considered invaluable in research as model organisms. This is a useful compilation for students and researchers in microbiology, biotechnology and chemical industries.

The field of industrial microbiology involves a thorough knowledge of the microbial physiology behind the processes in the large-scale, profit-oriented production of microbe-related goods which are the subject of the field. In recent times a paradigm shift has occurred, and a molecular understanding of the various processes by which plants, animals and microorganisms are manipulated is now central to industrial microbiology. Thus the various applications of industrial microbiology are covered broadly, with emphasis on the physiological and genomic principles behind these applications. Relevance of the new elements such as bioinformatics, genomics, proteomics, site-directed mutation and metabolic engineering, which have necessitated the paradigm shift in industrial microbiology are discussed.

This book was written with the purpose of providing a sound basis for the design of enzymatic reactions based on kinetic principles, but also to give an updated vision of the potentials and limitations of biocatalysis, especially with respect to recent app- cations in processes of organic synthesis. The ?rst ?ve chapters are structured in the form of a textbook, going from the basic principles of enzyme structure and fu- tion to reactor design for homogeneous systems with soluble enzymes and hete- geneous systems with immobilized enzymes. The last chapter of the book is divided into six sections that represent illustrative case studies of biocatalytic processes of industrial relevance or potential, written by experts in the respective ?elds. We sincerely hope that this book will represent an element in the toolbox of gr- uate students in applied biology and chemical and biochemical engineering and also of undergraduate students with formal training in organic chemistry, biochemistry, thermodynamics and chemical reaction kinetics. Beyond that, the book pretends also to illustrate the potential of biocatalytic processes with case studies in the ?eld of organic synthesis, which we hope will be of interest for the academia and prof- sionals involved in R&D&I. If some of our young readers are encouraged to engage or persevere in their work in biocatalysis this will certainly be our more precious reward.

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.

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

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.