Biotechnology overview

Modern biotechnology covers various technologies related to the use of living organisms or their products for food or medical industry by the way of improving plants and animals, developing organisms for specific uses, and improving human health and usual environment.

Biotechnology is an ancient and well-developed science that affects our daily lives. Since the dawn of time plants and animals were selectively bred and microorganisms were used for production of foods such as bread, cheese, wine, and beer. Some samples found by archaeologists may be dating back as far as to 5000 BC.

Much time has passed since the evolution of the early biotechnology and today's modern biotech industry that applies recombinant DNA on a production scale and many achievements have been reached since then, the greatest of them being the following:

• Biological heredity experiments and discoveries in the field of genetics (by Gregor Mendel, 1865).
• Description of structure of double-spiral DNA (James Watsonn and Francis Crick, 1953).
• First experiments with recombinant DNA (Walter Gilbert, 1973).
• Foundation of Genentech, the first biotech company that announced in 1978 the production of Somatostatin, the first human protein ever produced from bacteria (1976).
• John Baxter announces a successful cloning of a human growth hormone (1979).
• Scientists at Biogen company are the first to announce the expression of biologically active recombinant human leukocyte alfa interferon (1980).
• Industrial production of the first recombinant protein - insulin (1982, produced by Eli Lilly under a Genentech license).
• Genentech receives a Food and Drug Administration (FDA) approval for release into market of human recombinant growth hormone for treatment of children with diagnosed growth hormone deficiency (1982).
• Genentech transfers the license for the production of recombinant interferon alfa-2b to Hoffman-La Roche company which obtains an FDA approval in 1986 regarding the suitability of this medicine for the treatment of leukaemia and obtains permission in 1987 to start a mass production of genetically modified plasminogen activator and recombinant Hepatitis B vaccine.
• Amgen company obtains an FDA approval regarding the suitability of genetically modified erythropoietin for the treatment of kidney failure and anaemia (1989).
• The start of Humane Genome Project, an international attempt to decode all genes contained in a human cell (1990).
• Publication of the final version of Human Genome (2003).

Modern biotechnologies based on recombinant DNA or hybridoma techniques (the technology of production of specific antibodies) are applied in production of new food and pharma products and help solving environmental problems. This supports the division of biotechnologies into several areas such as agricultural, industrial, environmental, and pharmaceutical biotechnology.

Pharmaceutical biotech involves the production of pharmaceutical protein preparations: vaccines, diagnostic proteins, and proteins for treatment of humans. Biological, chemical, and engineering principles help to develop technologies allowing the production of large amounts of proteins or other biological materials. These processes take place at specialised plants where media and buffer solutions are prepared, microorganisms or cell cultures are grown, and bio-product recovery and purification is performed. All processes are supervised by quality control specialists. All production processes must comply with current requirements of Good Manufacturing Practice (GMP).

Today, hundreds of biotech companies are performing clinical trials of over 350 medicinal products and vaccines, hundreds more are engaged in development of various biopharma projects. Such projects will eventually result in future drug products, diagnostic tests, and genetic modifications of plants and animals. The majority of new pharma products are designed for the treatment of diseases still resilient to traditional drug products. Scientists have learned how to manipulate DNA and proteins, two crucial elements of life. This allows the biotech science to cover vast areas, from the production of genetically modified drug products to the cloning of Dolly, the famous sheep.

The next step after the initial version of determination of human genome sequence is complete is discovering new types of drug products. The number of discovered, tested, and released pharma products is expected to increase 6 times over the next two decades.

The share of biotech products in the global medicine market was 15% in 2000 and increased to 35% in 2001. The same trend remains in the EU: the share of biotech products (88 recombinant proteins and preparations based on monoclonal antibodies) was 35% among all drug products newly registered in the EU since 1995 [Walsh G., Eur J Pharm Biopharm. 2003; 55(1):3–10].

Not only have the modern diagnostic and gene engineering technologies led to improvement of medicinal therapies, they have provided the opportunity to investigate the patient's individual genetic structure prior to the selection of specific drug products. Such treatment methods will become widely available in the next 15-20 years.