This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.

This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.

Safety in Industrial Microbiology and Biotechnology reviews the hazards involved in work with both naturally occurring and genetically-modified microorganisms. This text is divided into 12 chapters and begins with an overview of the laboratory- and industry-associated infection hazards. The subsequent chapters deal with the legal issues, containment, risk assessment, and pathogenicity testing of infection related to industrial microbiology and biotechnology. These topics are followed by discussions of the safety considerations in recombinant plasmid preparation, the safe handling of industrially-produced mammalian cells, and some genetic designs that can be applied to processes based on recombinant DNA microorganisms. Other chapters explore the design for safety in bioprocessing and the containment in the development and manufacture of recombinant DNA-derived products. The remaining chapters look into the monitoring and validation in biotechnological processes, as well as the occupational health implications of industrial biotechnology. This book will prove useful to biotechnologists, microbiologists, safety engineers, and researchers.

The experience of Eli Lilly and Co. has demonstrated that large-scale bioprocessing can be conducted under conditions that provide safety for the fermentation operator as well as the environment. Thirty years of medical surveillance of workers associated with large-scale bioprocessing has shown no increased incidence of morbidity or mortality associated with these processes. Over 100 000 h of experience with large-scale recombinant DNA fermentations has demonstrated that, with proper design and validation criteria, genetically engineered microorganisms can be developed and the operation scaled to efficient and economical processes with excellent protection to the environment and the operating personnel. Large-scale mammalian cell culture processes, which possess their own unique set of bio-safety issues, are being developed with safeguards that ensure the use of well-characterized cell lines, the inactivation of process streams, and the elimination of risk to the bioprocess operators.

As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.

Bioprocess Engineering involves the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials. It also deals with studying various biotechnological processes. "Bioprocess Kinetics and Systems Engineering" first of its kind contains systematic and comprehensive content on bioprocess kinetics, bioprocess systems, sustainability and reaction engineering. Dr. Shijie Liu reviews the relevant fundamentals of chemical kinetics-including batch and continuous reactors, biochemistry, microbiology, molecular biology, reaction engineering, and bioprocess systems engineering- introducing key principles that enable bioprocess engineers to engage in the analysis, optimization, design and consistent control over biological and chemical transformations. The quantitative treatment of bioprocesses is the central theme of this book, while more advanced techniques and applications are covered with some depth. Many theoretical derivations and simplifications are used to demonstrate how empirical kinetic models are applicable to complicated bioprocess systems. - Contains extensive illustrative drawings which make the understanding of the subject easy - Contains worked examples of the various process parameters, their significance and their specific practical use - Provides the theory of bioprocess kinetics from simple concepts to complex metabolic pathways - Incorporates sustainability concepts into the various bioprocesses

It is now more than half a century since animal cells first came into regular use in the laboratory. Instances of laboratory acquired infection and con tamination of therapeutic products, derived from the use of animal cell cultures are rare. The use of animal cells, in addition to an established role in the production of vaccines and therapeutic proteins, has many new medical applications including gene therapy, tissue engineering and cell therapy. Furthermore, C;ldvances in molecular and cell biology are enabling rapid development and application of these technologies and the development of new and more sensitive methods, such as nucleic acid amplification, for the characterisation of cells and the detection of adven titious agents. However, it is clear that there is no room for complacency in this field and the recent expansion in the use of animal cells in the manufacture of medical products and the development of new biological assays for diagnostic and pharmaco-toxicological screening, underlines the need for vigilance regarding the correct and safe use of animal cells as substrates. This book is therefore very timely and should prove to be a highly valuable text, finding a wider audience beyond those with respon sibility for laboratory safety. The book guides the reader from fundamental cell biology issues and the establishment of new in vitro methods, through testing and validation of cell lines and on to issues in the use of animal cells in manufacturing processes.

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference