P. Hambleton – författare

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.

Biotechnology is now applied to the production of a wide range of chemical, pharmaceutical, agricultural and food products. Increasingly, there has been a need for the biotechnological processes themselves, not just the products, to be regulated and for possible hazards to be identified. This book provides a practical approach to the industrial and international regulatory aspects of biosafety in biotechnology. Chapters cover relevant national (and international) legal requirements, policy-making bodies and regulatory agencies, providing practical guidelines to industry on how to comply with the regulations. Industrial aspects covered include a review of potential health hazards, effluent management and equipment monitoring procedures. This book is an essential source of practical advice and reference for industrial biotechnologists, particularly those with responsibility for safety, ecotoxicologists, health inspectors and chemical engineers.This book should be of interest to production managers, quality managers, safety managers and biological safety officers in biotechnology and pharmaceutical companies; process equipment designers, fabricators and users; and researchers and lecturers in biochemical engineering, biotechnology process design and development, industrial hygiene and occupational health departments in universities and technical colleges.

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.

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.

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.