Introduction

While modern biotechnology may be considered as one of the main economic development forces for the twenty-first century, it equally presents far-reaching legal, moral and ethical implications for society. Central to the application of biotechnological techniques to a wide range of industries is gene technology – a controversial and emotive subject.

In the industrialised world, public policy makers on biotechnology have been influenced by the concerted interests of governments, industries, academia and environmental groups. Nationally and internationally, such policies are being developed within a climate of tension and conflicting aims. Central to most of these debates is the single main issue – should regulation be dependent on the characteristics of the products modified by recombinant DNA (rDNA) technology or on the use of the rDNA technology per se? The product-versus-process debate has continued for many years and exposes conflicting views on what should represent public policies on new technology development. What is public interest? Should this be left to the scientists and technologists to decide or should the ‘public’ become part of such decision-making processes? The many crucial decisions to be made will affect the future of humanity and the planet's natural resources. Such decisions should be based on the best scientific information in order to allow effective choices for policy options.

As world populations continue to increase, there is also a growing per capita demand for energy. Coupled to this are the international commitments to reduce carbon dioxide emissions that were agreed at the Kyoto Conference.

Photosynthesis: the ultimate energy resource

The total economically recoverable world reserves of the three main fossil fuels, namely coal, natural gas and oil – applying current technology and assuming continued consumption of present-day rates – are, respectively, less than 1000 years, 35 years and 16 years. Modern industry is almost totally dependent on these limited supplies. Approximately 93% of fossil fuel consumed throughout the world is for energy production, with only 7% being used by industry for the production of solvents, plastics and a host of other organic chemicals.

The continual depletion of global fossil-fuel energy has generated an ever-increasing need to seek out alternative sources of energy. These have so far included: the harnessing of hydro-, tidal, wave and wind power; the capture of solar and geothermal energy supplies; and the much misunderstood, but most significant – nuclear power. With all of these systems there is as yet no definitive answer on both the economic and energetic outlay necessary for successful operation. However, it cannot be doubted that fossil fuels will disappear completely in the not too distant future.

Introduction

During the twentieth century there have been the greatest gains in health in most parts of the world owing to dramatic reductions in infant mortality, eradication of life-threatening diseases such as smallpox, and considerable improvements in life expectancy in developing and industrialised countries. In the past, life for most people was coarse, lacking in adequate nutrition, with poor housing and, above all, short in years. With the advent of improved sanitation and better living conditions, together with the availability of vaccinations and antibiotics, there has been, for many, a vast improvement in health status. However, health status still differs widely among nations and by geographic region. For instance, life expectancy is less than 50 years in some sub-Saharan African countries, but over 75 years in established industrialised countries. The wealthiest economies appear to be the healthiest. A crucial factor related to life expectancy is access to safe water! In much of the developing world, simply drinking water is a high-risk exposure.

Undoubtedly, the real gains in health over the last century can be attributed mainly to the impact of public health and disease prevention rather than to medical interventions. Public health can be primarily distinguished from clinical medicine by placing emphasis on the prevention of disease rather than the curing, and having a main focus on population and communities rather than on the individual patient.

The nature of enzymes

Enzymes are complex organic molecules present in living cells where they act as catalysts in bringing about chemical changes in substances. With the development of the science of biochemistry has come a fuller understanding of the wide range of enzymes present in living cells and of their modes of action. Without enzymes, there can be no life. Although enzymes are only formed in living cells, many can be separated from the cells and can continue to function in vitro. This unique ability of enzymes to perform their specific chemical transformations in isolation has led to an ever-increasing use of enzymes in industrial and food processes, in bioremediation, and in medicine, and their production is collectively termed ‘enzyme technology’.

The activity of an enzyme is due to its catalytic nature. An enzyme carries out its activity without being consumed in the reaction, and the reaction occurs at a very much higher rate when the enzyme is present. Enzymes are highly specific and function only on designated types of compounds – the substrates. A minute amount of enzyme can react with a large amount of substrate. The catalytic function of the enzyme is due not only to its primary molecular structure but also to the intricate folding configuration of the whole enzyme molecule. It is this configuration which endows the protein with its specific catalytic function; disturb the configuration by, for example, a change in pH or temperature, and the activity can be lost.

The British National Economic Development Office has projected that the sales worldwide from new biotechnology could exceed £60 billion per annum by early this century. This will be derived from a wide range of biotechnology-based products and processes which have evolved, in most cases, from many years of expensive research and development. How can such biotechnology products and processes be protected and the due financial profits returned to the rightful inventors and industrial developers? Inventors in the area of biotechnology can be protected by way of different titles of protection, including patents for invention, plant breeders' rights and trade secrets. In the context of biotechnology inventions can be in the form of products or processes.

Products

These can be considered either as living entities of natural or artificial origin, e.g animals, plants and microorganisms, cell lines, organelles, plasmids and DNA sequences, or as naturally occurring substances – primary or secondary – derived from living systems.

Processes

These can include those of isolation, cultivation, multiplication, purification and bioconversion. Such processes can be involved in: the isolation or the creation of the above products, e.g. antibiotic production; the production of substances through bioconversion of products, e.g. enzymatic conversion of sugar to alcohol; or the use of the products for any purpose, e.g. monoclonal antibodies used for analysis or diagnosis, or microbes used for biocontrol of pathogens.

Introduction

As societies throughout the world are increasingly moving to greater levels of urbanisation and industrial development, public concern is mounting over the state of the environment, and much attention is now being given to improving the environment for future generations. To achieve this, there has been, particularly in developed nations, major environmental legislation directed towards liquid, solid and hazardous wastes. In most developing countries the situation is less encouraging, where financing is limited, or not available, for the construction of water and waste-treatment facilities and where there is a shortage of trained personnel to operate the systems. Furthermore, in many developing countries there is a lack of official regulations and control systems, no administration bodies responsible for waste control, and little obligation for existing and emerging industries to dispose of waste properly. Also, it is in such countries that there is the greatest movement towards urbanisation and new industrial development, with concomitant destruction of the environment.

Waste generation is a side-effect of consumption and production activities, and tends to rise with the level of economic advance. Wastes arise from domestic and industrial activity, e.g. sewage, waste waters, agriculture and food wastes from processing, wood wastes, and an ever-increasing range of toxic industrial chemical products and by-products. In the final assessment, wastes represent the end of the technical and economic life of products.

Biotechnology has been shown to be a spectrum of enabling technologies which are increasingly being applied in many aspects of modern society. The applied use of biological systems, especially microorganisms, in such processes as brewing, wine making and cheese production was primarily accomplished in an empirical manner, with the management of these processes seen more as an art rather than a science. In recent times these ancient biotechnological processes have been subjected to rigorous scientific study and analysis, which has largely led to the replacement of traditional empiricism. Better understanding of microbial strain selection, molecular biology and genetics, together with improved bioprocess technology, have yielded major advances in all of the traditional biotechnology industries and will continue to achieve improved quality and safety together with cost-effectiveness.

A central feature of new biotechnological advances derives from an increasing understanding of the mechanisms of life and how these will eventually transform human lives as well as give a deeper appreciation of agriculture, aquaculture, forestry and the biological environment. The ability to select and manipulate genetic material within and outwith species has permitted unprecedented opportunities to alter life forms for the benefit of society. The successful sequencing of the human and other genomes is the beginning of a new scientific period of discovery. However, rather than genomic sequences being an end in themselves, it is but the beginning of scientific study to put the information into context with regard to the biological significance to the organism.

Introduction

In previous chapters the many applications of biotechnology can be divided into the traditional domains of fermentation for the production of various potable beverages, bread, cheese, organic acids, antibiotics and waste treatment, and the new biotechnologies, including production and use of genetically modified organisms for the large-scale production of vaccines, therapeutic proteins and other health products, together with the use of hybridomas for the production of monoclonal antibodies for diagnostic and therapeutic end-points. As such, biotechnology spans a vast range of industrial activities, and considerations of biosafety can potentially encompass activities within the research laboratory, the process plant, the final product and, in many cases, the environment. The term ‘biosafety’ has evolved as a new area of corporate activity created as an inevitable response generated by an expanding biotechnology industry and its increasing influence upon may aspects of commercial and public life. In particular, the many public issues recently generated, especially in Europe, concerning genetically modified crop trials have done much to raise the profile of this subject.

In all biotechnology processes, however, safety is of paramount importance. Table 13.1 lists the main areas of consideration for safety aspects in biotechnology.

Concepts of hazard and risk

Essential to the understanding of biosafety are the recognition and appreciation of the terms ‘hazard’ and ‘risk’. In the context of health and safety, ‘hazard’ can be a substance, object or situation with a potential for an accident or damage, and ‘risk’ is the likelihood that this will occur (Table 13.2).

The need for protein

A major challenge to creating a sustainable future for the world's populations will be to secure adequate food supplies for the majority. The number of humans in the world now approximates six billion, and increasing, and could well be over nine billion within the next 25 years (Fig. 7.1). Fortunately, recent statistics suggest that world population growth rate is slowing but, even so, overall numbers are increasing. Patterns of births worldwide indicate that over 90% are occurring in the southern hemisphere, where already 80% of the world's population live, yet they only use 20% of the world's resources.

It is also estimated that, by 2030, urban populations will be at least twice that of rural populations. The growth of urbanisation, together with ensuing environmental degradation, causes serious losses in the availability of productive agricultural land. In many parts of the world, such as Africa, soil fertility is declining and is further exacerbated by increasing water scarcity in the southern hemisphere. Furthermore, worldwide climate changes and increasing civil strifes continue to make accurate predictions of future food supplies unpredictable.

It is becoming increasingly documented that conventional agriculture will struggle to supply sufficient food, in particular protein, to satisfy a growing world population.

However, productivity is increasing throughout the world in all branches of agriculture. Biotechnological innovations will accelerate this trend (Chapter 10). Food surpluses are occurring in many places, particularly in North America and western Europe, where there are near static populations.

Introduction

Bioprocess or fermentation technology is an important component of most ‘old’ and ‘new’ biotechnology processes and will normally involve complete living cells (microbe, mammalian or plant), organelles or enzymes as the biocatalyst and will aim to bring about specific chemical and/or physical changes in organic materials (the medium). In order to be viable in any specific industrial context, bioprocessing must possess advantages over competing methods of production such as chemical technology. In practice, many bioprocessing techniques will be used industrially because they are the only practical way in which a specific product can be made (e.g. vaccines, antibiotics).

The very beginnings of fermentation technology, or as it is now better recognised, ‘bioprocess technology’, were derived in part from the use of microorganisms for the production of foods such as cheeses, yoghurts, sauerkraut, fermented pickles and sausages, soy sauce, and other Oriental products, and beverages such as beers, wines and derived spirits (Table 4.1). In many cases, the present-day production processes for such products are still remarkably similar. These forms of bioprocessing were long viewed as arts or crafts but are now increasingly subjected to the full array of modern science and technology. Paralleling these useful product formations was the identification of the roles that microorganisms could play in removing obnoxious and unhealthful wastes, which has resulted in worldwide service industries involved in water purification, effluent treatment and solid waste management (Chapter 9).

Introduction

Food production is the largest worldwide industry and, in industrialised nations, the expenditure on food can account for at least 20–30% of household budgets. The food industry has evolved through specialist trades or occupations, e.g. butchers, bakers and confectioners, to national and multinational organisations involved in the manufacture and distribution of food on a worldwide scale. With the improvement in means of transportation, foods are available on a worldwide basis and developments in food preservation methods give independence for seasonal availability.

In essence, the food industry now serves the function of supplying society with high-quality, wholesome foods all the year round, and at a distance – in time and location – from the place of primary production.

The food chain has its origins in production agriculture, with the planting of the seed or the rearing of animals, and concludes with the utilisation of the food products by the consumer. Apart from fruits and vegetables, most raw food materials, e.g. cereals and meats, will require some degree of processing. The link between the products of the farm and the consumer is the food processing industry, whereby relatively bulky, perishable, raw agricultural products are transformed into shelf-stable, convenient and palatable foods and beverages.

Biotechnology is, in essence, the deciphering and use of biological knowledge. It is highly multidisciplinary since it has its foundations in many disciplines, including biology, microbiology, biochemistry, molecular biology, genetics, chemistry and chemical and process engineering. It may also be viewed as a series of enabling technologies that involve the practical application of organisms (especially microorganisms) or their cellular components to manufacturing and service industries and environmental management. Historically, biotechnology was an artisanal skill rather than a science, exemplified by the manufacture of wines, beers, cheese, etc., where the techniques of manufacture were well worked out and reproducible, while the biological mechanisms were not understood. As the scientific basis of these biotechnology processes has developed, this has led to more efficient manufacturing of the traditional processes that still represent the major financial rewards of biotechnology. Modern biotechnological processes have generated a wide range of new and novel products, including antibiotics, recombinant proteins and vaccines, and monoclonal antibodies, the production of which has been optimised by improved fermentation practices. Biotechnology has been further revolutionised by a range of new molecular innovations, allowing unprecedented molecular changes to be made to living organisms. Genomics and proteomics are now heralding a new age of biotechnology, especially in the areas of human health and food production. In the environment, biotechnology innovations are creating major advances in water and land management and also remediating the pollution guaranteed by over-industrialisation.

Introduction

In essence, all properties of organisms depend on the sum of their genes. There are two broad categories of genes: structural and regulatory. Structural genes encode for amino acid sequences of proteins which, as enzymes, determine the biochemical capabilities of the organism by catalysing particular synthetic or catabolic reactions or, alternatively, play more static roles as components of cellular structures. In contrast, the regulatory genes control the expression of the structural genes by determining the rate of production of their protein products in response to intra- or extracellular signals. The derivation of these principles has been achieved using well-known genetic techniques which will not be considered further here.

The seminal studies of Watson and Crick and others in the early 1950s led to the construction of the double-helix model depicting the molecular structure of DNA and subsequent hypotheses on its implications for the understanding of gene replication. Since then there has been a spectacular unravelling of the complex interactions required to express the coded chemical information of the DNA molecule into cellular and organismal expression. Changes in the DNA molecule making up the genetic complement of an organism is the means by which organisms evolve and adapt themselves to new environments.

Introduction

Globally, agriculture and food production are challenged to produce, in a sustainable way, sufficient, healthy and safe food for the further growing world population. It is estimated that nearly eight billion people will be living on this planet by 2020, with 3.5 billion living in urban areas. To feed this world population there will need to be substantial increases in the production of the staple food commodities, namely cereals (40% increase), meat (63%) and roots and tubers (40%). At least 80% of this food will need to be produced in developing countries, yet only about 6% of new virgin soil can be brought into cultivation. Mankind must, somehow, raise yields from areas planted with cereals (two-thirds of all energy in the human diet) to approximately double the present value. Consequently, there can be no alternative other than to plan, with modern scientific inputs, new agricultural systems that are sustainable yet intensive. Whereas in the last great ‘green revolution’ in agriculture in the 1960s to 1970s, the environment was adapted to the plant by increased use of fertilisers, biocides, irrigation, etc., modern sustainable agriculture must increasingly adapt the plant to the environment, breeding high-yielding crops that can grow in places deficient in nitrogen or water, and where plant diseases and pests prevail. Many aspects of modern biotechnology are, and will increasingly be, applied to agriculture.

A biomass strategy

It has been estimated that the annual net yield of plant biomass arising from photosynthesis is at least 120 billion tonnes of dry matter on land and about 50 billion tonnes from the world's oceans. Of the land-produced biomass, approximately 50% occurs in the complex form of lignocellulose.

The highest proportion of land-based biomass (44%) is produced as forest (Table 2.1). It is surprising to note that while agricultural crops account for only 6% of the primary photosynthetic productivity, from this amount is derived a major portion of food for humans and animals as well as many essential structural materials, textiles and paper products (Table 2.2). Many traditional agricultural products may well be further exploited with the increasing awareness of biotechnology. In particular, new technological approaches will undoubtedly be able to utilise the large volume of waste material from conventional food processing that presently finds little use.

Biomass agriculture, aquaculture and forestry may hold great economic potential for many national economies, particularly in tropical and subtropical regions (Fig. 2.1). Indeed, the development of biotechnological processes in developing areas where plant growth excels could well bring about a change in the balance of economic power. world has drawn heavily on fossil fuels that took millions of years to form beneath the beds of the oceans or in the depths of the earth. Furthermore, it is a very unequal pattern of usage.