Bioprocessing Safety
Author: Warren C. Hyer
Publisher: ASTM International
Published: 1990
Total Pages: 167
ISBN-13: 0803112645
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Guidelines for Process Safety in Bioprocess Manufacturing Facilities
Author: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
Published: 2011-12-28
Total Pages: 244
ISBN-13: 1118009002
DOWNLOAD EBOOKThis 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.
Guidelines for Process Safety in Bioprocess Manufacturing Facilities
Author: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
Published: 2010-11-23
Total Pages: 244
ISBN-13: 0470251492
DOWNLOAD EBOOKThis 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 Bioprocessing
Author: MA. Foglesong
Publisher:
Published: 1990
Total Pages: 6
ISBN-13:
DOWNLOAD EBOOKThe 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.
Disposable Bioprocessing Systems
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Published: 2011-12-19
Total Pages: 325
ISBN-13: 1439866708
DOWNLOAD EBOOKBecause of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems. Written by a researcher and professor with hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide, and creating model facilities using maximum disposable technology, this book is the first comprehensive introduction to understanding disposable systems. It gives an overview of the current state of the disposable bioprocessing industry, resolves all controversial issues, and guides readers in choosing disposable components that meet their needs. An important chapter on safety addresses facts and myths about the use of plastics and elastomers—including the issue of leaching—and how to ensure regulatory compliance. Helping readers understand their choices, the book describes the equipment and systems available to prepare the starting materials for the manufacturing of biological drugs—from disposable containers to filters. The author also discusses costs, regulations, and concerns about waste disposal, and shares his predictions for the future of the disposable bioprocessing industry. A practical manual for those interested in the transition to disposable systems, this book will also interest students of bioprocessing. It offers a timely view of disposable bioprocessing technology as a "game changer" that will facilitate developing new drugs and conducting research in the emerging field of stem cells and gene therapy.
Biosafety in Industrial Biotechnology
Author: P. Hambleton
Publisher: Springer Science & Business Media
Published: 2012-12-06
Total Pages: 317
ISBN-13: 9401113521
DOWNLOAD EBOOKAs 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.
Perspectives on Opportunities Toward a Hazard-Free Bioprocessing Environment
Author: LJ. Elliott
Publisher:
Published: 1990
Total Pages: 7
ISBN-13:
DOWNLOAD EBOOKPractical research and commercial applications of biotechnologies are expanding rapidly. The increasing utilization of biotechnology is evident in the areas of clinical research, general medicine, agriculture, chemical synthesis, and waste disposal, to name only a few. In an effort to identify potential occupational health hazards during the early stages of this development, the National Institute for Occupational Safety and Health conducted industrial hygiene surveys at six companies involved in research and development of recombinant DNA (rDNA) techniques applicable to fermentation processes. During each visit potential worker exposures, engineering controls, work practices, and medical surveillance programs were assessed. Varying degrees of proficiency and sophistication were noted in all of the assessed areas. Three companies new to the field (less than ten years old) of industrial fermentation were less sophisticated in their approach to issues involving occupational safety and health than were companies with years of experience (20, 25, and 106 years) in such operations. The three less experienced companies had no operational protocols, conducted limited (if any) environmental monitoring for chemical and microbial hazards, did not conduct preventive maintenance, and had very limited medical surveillance programs. Two of these companies had not conducted any environmental monitoring of the fermentation or product extraction processes. Recommendations were made in the areas of preventive maintenance, environmental monitoring, medical surveillance, and improved containment during fermenter inoculation.
Bioprocessing of Viral Vaccines
Author: Amine Kamen
Publisher: CRC Press
Published: 2022-09-06
Total Pages: 267
ISBN-13: 1000643050
DOWNLOAD EBOOKThis book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.
Bioprocessing Technology in Food and Health: Potential Applications and Emerging Scope
Author: Deepak Kumar Verma
Publisher: CRC Press
Published: 2018-09-21
Total Pages: 334
ISBN-13: 1351167863
DOWNLOAD EBOOKThe functional foods market represents one of the fastest growing and most fascinating areas of investigation and innovation in the food sector. This new volume focuses on recent findings, new research trends, and emerging technologies in bioprocessing: making use of microorganisms in the production of food with health and nutritional benefits. The volume is divided into three main parts. Part I discusses functional food production and human health, looking at some newly emerged bioprocessing technological advances in the functional foods (chocolates, whey beverages) in conjunction their prospective health benefits. Part II, on emerging applications of microorganism in safe food production, covers recent breakthroughs in food safety in microbial bioprocessing. Chapters discuss spoilage issues, harmful/pathogenic microorganisms, genetically modified microorganisms, stability and functionality, and potential of food-grade microbes for biodegradation of toxic compounds, such as mycotoxins, pesticides, and polycyclic hydrocarbons. Chapters in Part III, on emerging scope and potential application in the dairy and food industry, explore and investigate the current shortcomings and challenges of the microbially mediated processes at the industrial level. The editors have brought together a group of outstanding international contributors at the forefront of bioprocessing technology to produce a valuable resource for researchers, faculty, students, food nutrition and health practitioners, and all those working in the dairy, food, and nutraceutical industries, especially in the development of functional foods.
Safety in Cell and Tissue Culture
Author: G. Stacey
Publisher: Springer Science & Business Media
Published: 2012-12-06
Total Pages: 257
ISBN-13: 940114916X
DOWNLOAD EBOOKIt 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.
