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Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.
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.
Bioprocess Engineering: Kinetics, Sustainability, and Reactor Design, Second Edition, provides a comprehensive resource on bioprocess kinetics, bioprocess systems, sustainability, and reaction engineering. Author Dr. Shijie Liu reviews the relevant fundamentals of chemical kinetics, batch and continuous reactors, biochemistry, microbiology, molecular biology, reaction engineering, and bioprocess systems engineering, also introducing key principles that enable bioprocess engineers to engage in analysis, optimization, and design with consistent control over biological and chemical transformations. The quantitative treatment of bioprocesses is the central theme in this book, with more advanced techniques and applications being covered in depth. This updated edition reflects advances that are transforming the field, ranging from genetic sequencing, to new techniques for producing proteins from recombinant DNA, and from green chemistry, to process stability and sustainability. The book introduces techniques with broad applications, including the conversion of renewable biomass, the production of chemicals, materials, pharmaceuticals, biologics, and commodities, medical applications, such as tissue engineering and gene therapy, and solving critical environmental problems. Includes the mechanistic description of biotransformations and chemical transformations Provides quantitative descriptions of bioprocesses Contains extensive illustrative drawings, which make the understanding of the subject easy Includes bioprocess kinetics and reactor analysis Contains examples of the various process parameters, their significance, and their specific practical use Incorporates sustainability concepts into the various bioprocesses
Bioprocessing for Value-Added Products from Renewable Resources provides a timely review of new and unconventional techniques for manufacturing high-value products based on simple biological material. The book discusses the principles underpinning modern industrial biotechnology and describes a unique collection of novel bioprocesses for a sustainable future. This book begins in a very structured way. It first looks at the modern technologies that form the basis for creating a bio-based industry before describing the various organisms that are suitable for bioprocessing - from bacteria to algae - as well as their unique characteristics. This is followed by a discussion of novel, experimental bioprocesses, such as the production of medicinal chemicals, the production of chiral compounds and the design of biofuel cells. The book concludes with examples where biological, renewable resources become an important feedstock for large-scale industrial production. This book is suitable for researchers, practitioners, students, and consultants in the bioprocess and biotechnology fields, and for others who are interested in biotechnology, engineering, industrial microbiology and chemical engineering. ·Reviews the principles underpinning modern industrial biotechnology ·Provides a unique collection of novel bioprocesses for a sustainable future ·Gives examples of economical use of renewable resources as feedstocks ·Suitable for both non-experts and experts in the bioproduct industry
ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] * Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications [Q6A, Q6B] * Part VII: Good Manufacturing Practice [Q7] * Part VIII: Pharmaceutical Development [Q8(R2)] * Part IX: Quality Risk Management [Q9] * Part X: Pharmaceutical Quality System [Q10] Reference Tools * Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents * Part XII: Combined Glossary and Index for all Quality Guidance Documents
Current Developments in Biotechnology and Bioengineering: Bioprocesses, Bioreactors and Controls provides extensive coverage of new developments, state-of-the-art technologies, and potential future trends, reviewing industrial biotechnology and bioengineering practices that facilitate and enhance the transition of processes from lab to plant scale, which is becoming increasingly important as such transitions continue to grow in frequency. Focusing on industrial bioprocesses, bioreactors for bioprocesses, and controls for bioprocesses, this title reviews industrial practice to identify bottlenecks and propose solutions, highlighting that the optimal control of a bioprocess involves not only maximization of product yield, but also taking into account parameters such as quality assurance and environmental aspects. Describes industrial bioprocesses based on the reaction media Lists the type of bioreactors used for a specific bioprocess/application Outlines the principles of control systems in various bioprocesses
This book deals with bioprocess engineering, which encompasses the design and development of equipment and processes for the manufacturing of products such as food, pharmaceuticals, chemicals, polymers and paper from biological materials. It also deals with studying various biotechnological processes used in industries for large scale production of biological products, for the optimization of yield. This work also incorporates significant treatment on biocatalysts and their applications in food industry, bioplastics production, conversion of agro waste and the importance of biotechnology in bioprocessing. This is coupled with pertinent information related to environmental contaminants.

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