This book covers several bases at once. It is useful as a textbook for a second course in experimental optimization techniques for industrial production processes. In addition, it is a superb reference volume for use by professors and graduate students in Industrial Engineering and Statistics departments. It will also be of huge interest to applied statisticians, process engineers, and quality engineers working in the electronics and biotech manufacturing industries. In all, it provides an in-depth presentation of the statistical issues that arise in optimization problems, including confidence regions on the optimal settings of a process, stopping rules in experimental optimization, and more.

Bioprocess technology involves the combination of living matter (whole organism or enzymes ) with nutrients under laboratory conditions to make a desired product within the pharmaceutical, food, cosmetics, biotechnology, fine chemicals and bulk chemicals sectors. Industry is under increasing pressure to develop new processes that are both environmentally friendly and cost-effective, and this can be achieved by taking a fresh look at process development; - namely by combining modern process modeling techniques with sustainability assessment methods. Development of Sustainable Bioprocesses: Modeling and Assessment describes methodologies and supporting case studies for the evolution and implementation of sustainable bioprocesses. Practical and industry-focused, the book begins with an introduction to the bioprocess industries and development procedures. Bioprocesses and bioproducts are then introduced, together with a description of the unit operations involved. Modeling procedures, a key feature of the book, are covered in chapter 3 prior to an overview of the key sustainability assessment methods in use (environmental, economic and societal). The second part of the book is devoted to case studies, which cover the development of bioprocesses in the pharmaceutical, food, fine chemicals, cosmetics and bulk chemicals industries. Some selected case studies include: citric acid, biopolymers, antibiotics, biopharmaceuticals. Supplementary material provides hands-on materials so that the techniques can be put into practice. These materials include a demo version of SuperPro Designer software (used in process engineering) and models of all featured case studies, excel sheets of assessment methods, Monte Carlo simulations and exercises. Previously available on CD-ROM, the supplementary material can now be accessed via http://booksupport.wiley.com by entering the author name, book title or isbn and clicking on the desired entry. This will then give a listing of all the content available for download. Please read any text files before downloading material.

The emergence and refinement of techniques in molecular biology has changed our perceptions of medicine, agriculture and environmental management. Scientific breakthroughs in gene expression, protein engineering and cell fusion are being translated by a strengthening biotechnology industry into revolutionary new products and services. Many a student has been enticed by the promise of biotechnology and the excitement of being near the cutting edge of scientific advancement. However, graduates trained in molecular biology and cell manipulation soon realise that these techniques are only part of the picture. Reaping the full benefits of biotechnology requires manufacturing capability involving the large-scale processing of biological material. Increasingly, biotechnologists are being employed by companies to work in co-operation with chemical engineers to achieve pragmatic commercial goals. For many years aspects of biochemistry and molecular genetics have been included in chemical engineering curricula, yet there has been little attempt until recently to teach aspects of engineering applicable to process design to biotechnologists.This textbook is the first to present the principles of bioprocess engineering in a way that is accessible to biological scientists. Other texts on bioprocess engineering currently available assume that the reader already has engineering training. On the other hand, chemical engineering textbooks do not consider examples from bioprocessing, and are written almost exclusively with the petroleum and chemical industries in mind. This publication explains process analysis from an engineering point of view, but refers exclusively to the treatment of biological systems. Over 170 problems and worked examples encompass a wide range of applications, including recombinant cells, plant and animal cell cultures, immobilised catalysts as well as traditional fermentation systems.* * First book to present the principles of bioprocess engineering in a way that is accessible to biological scientists* Explains process analysis from an engineering point of view, but uses worked examples relating to biological systems* Comprehensive, single-authored* 170 problems and worked examples encompass a wide range of applications, involving recombinant plant and animal cell cultures, immobilized catalysts, and traditional fermentation systems* 13 chapters, organized according to engineering sub-disciplines, are groupled in four sections - Introduction, Material and Energy Balances, Physical Processes, and Reactions and Reactors* Each chapter includes a set of problems and exercises for the student, key references, and a list of suggestions for further reading* Includes useful appendices, detailing conversion factors, physical and chemical property data, steam tables, mathematical rules, and a list of symbols used* Suitable for course adoption - follows closely curricula used on most bioprocessing and process biotechnology courses at senior undergraduate and graduate levels.

Food process modelling provides an authoritative review of one of the most exciting and influential developments in the food industry. The modelling of food processes allows analysts not only to understand such processes more clearly but also to control them more closely and make predictions about them. Modelling thus aids the search for greater and more consistent food quality. Written by a distinguished international team of experts, Food process modelling covers both the range of modelling techniques and their practical applications across the food chain.

The second edition of Comprehensive Biotechnology, Six Volume Set continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work serves the needs of newcomers as well as established experts combining the latest relevant science and industry practice in a manageable format. It is a multi-authored work, written by experts and vetted by a prestigious advisory board and group of volume editors who are biotechnology innovators and educators with international influence. All six volumes are published at the same time, not as a series; this is not a conventional encyclopedia but a symbiotic integration of brief articles on established topics and longer chapters on new emerging areas. Hyperlinks provide sources of extensive additional related information; material authored and edited by world-renown experts in all aspects of the broad multidisciplinary field of biotechnology Scope and nature of the work are vetted by a prestigious International Advisory Board including three Nobel laureates Each article carries a glossary and a professional summary of the authors indicating their appropriate credentials An extensive index for the entire publication gives a complete list of the many topics treated in the increasingly expanding field

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies

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 devel

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.