Photo: GSK Marburg

Biotechnology and biopharmaceuticals

(last update: March 2016, Matthieu Stettler)

Biotechnology is not an innovation of the 20th century but has been an important part of the human civilization for many thousands of years. Microbiological fermentation has been used to meet the nutritional needs of human beings and animals for centuries. Without fermentation our diet would be poorer, and far less varied than it is today, fermentation allows us to store food that would otherwise degrade and become inedible very quickly. This can be done directly (cabbage to sauerkraut) or indirectly by producing vinegar for use in pickling. In addition, the taste and texture of foods can be improved as a result of microbial action. Yeast has been used to produce bread, beer, wine, all of which have been found in the early Egyptian pyramids. A variety of bacterial strains are employed in the production of cheese, curds and yogurt. In Asia, microbial fermentations are used to modify soya, peanuts and other products. Lactobacilli produce animal fodder from green plant material stored in silos. All of these are examples of biotechnological products, which have been accepted as natural products.

Industrial fermentation

Industrial fermentation is a recent development, which has grown from the understanding of the basic scientific background for these naturally occurring events to established technologies which can be used to produce large amounts of antibiotics, vitamins and steroids for the prevention and treatment of a variety of diseases. As a result, health and the life expectancy of both humans and agriculturally important animals has been improved. Furthermore, a broad spectrum of industrial chemicals, such as organic solvents and enzymes, can be produced by using biotechnological methodologies. Some of them are produced exclusively by biotechnology whereas others use the biotechnological methods to replace chemical reactions which can deplete and endanger the environment.

Modern biotechnology

Today, for many people, biotechnology has become synonymous with genetic engineering or the selective alteration and recombination of genetic material within living cells. The vast majority of products made for therapeutic use in modern biotechnology are made in bioreactors using genetically modified cells. Our understanding of how cells and disease work is expanding all the time. This expanded understanding in multiple disciplines such as cell biology, systems biology, molecular biology, genetics, immunology and genetic engineering has opened new perspectives for the future. With ‘classical’ biotechnology, the selection of interest was based on visible characters of an organism. In modern biotechnology, new techniques allow us to detect and select genes of choice, even if their expression is not visible, and transfer them to the desired cell line in a very efficient and faster way.

Modern biotechnology and biopharmaceuticals

Biotechnology can produce different types of products. There are three main groups:

  • Replacement products (insulin for diabetes, blood clotting factors for haemophilia, human growth factor, fertility hormones- in the longer term some gene therapy may fall into this category). Animal or human sources may have been used for some of these products in the past but there are problems with availability, consistency, safety and compatibility of these products.
  • Non replacement therapies such as antibiotics, antibodies, cytokines, and therapeutic vaccines to treat a range of diseases including infectious diseases, cancer and autoimmune diseases.
  • Preventive therapies – vaccination

Many of these products are used by patients for many years on a regular basis. These products must be produced in large quantities by methods that ensure the consistency, efficacy and safety of the product. The breakthrough in the pharmaceutical field has been to use the benefits of genetic engineering and biotechnology to produce these large, complex structures in sufficient amounts to be used in modern therapy. Biotechnological production processes are considered safer for the environment than many older, accepted technologies.

Safety assessments

Different European pharmaceutical industry associations have self-imposed restrictions for the manipulation of human derived material. There are clearly significant ethical questions in this area and balancing the needs of patient with diseases such as haemophilia or cystic fibrosis against other concerns will continue to be a challenge.

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