It is our goal to optimise the use of genetic engineering in the manufacturing of our products, not only to ensure high-quality and efficient production at our sites, but also as a boon to the environment.

The core technology used by Novo Nordisk is microbial fermentation to produce therapeutic proteins, the active ingredient in our pharmaceutical products. For each product, we develop specific genetically modified microorganisms (GMMs) that are suitable for producing that particular protein.

The main raw materials used in our closed fermentation tanks are water, nutrients and sugar. During the recovery and purification processes, we use organic chemicals (primarily ethanol), inorganic chemicals such as acids, bases and salts, and filter materials such as kieselgel.

The main by-product from our production is a nutrient-rich organic material known as yeast sludge, which is recycled either as pig feed (yeast cream) or as raw material for biogas generation. The biomass is deactivated by heating, ensuring that all microorganisms are killed.

We have optimised the use of resources in the development of our new generation of insulin products. Our new yeast strain is able to substantially reduce the consumption of water, energy and raw materials per produced unit, resulting in a significant improvement in environmental performance. The new generation of insulin products will be produced in a new plant in Kalundborg, which will start production in 2003.

The application of genetic engineering enables us to produce a variety of active proteins used for the production of biopharmaceuticals, various types of insulin for the treatment of diabetes, growth hormones, glucagon and clotting factors for haemostasis treatment. Our products do not contain GMMs as these are separated from the final products in the recovery process.

With genetic engineering, organisms are tailored to be more specific and more productive.
Modified organisms produce valuable substances that would otherwise be in short supply, or even impossible to produce. Without genetic engineering, it would not be possible to provide a sufficient and stable supply of high-quality insulin to the global market.

Some people are concerned about the risks associated with genetic engineering, of which we are keenly aware. We realise that safety is an important issue in managing modern biotechnology. The GMMs we use fulfil the widely adopted international criteria for microorganisms to be classified as safe or demonstrating the lowest potential risk. National laws regulate the use of GMMs for production purposes, with the aim to protect human health and the environment from any adverse effects.

Novo Nordisk only uses GMMs in closed production facilities – a method called 'contained use’. Since our GMMs are safe and well-known – presenting no risk to human health or to the environment – the release of a limited amount of GMMs from air emissions, solid and liquid waste is allowed. The limits are set by the authorities and regularly controlled. We monitor whether emitted GMMs have survived outside the production facilities. No viable production organisms have ever been identified in the samples.

In genetic engineering, specific uses of genes coding for resistance to antibiotics are considered to be associated with potential risk. Genes that make microorganisms resistant to some antibiotics (called ‘marker genes’) are normally used in genetic engineering for selecting successfully modified microorganisms. Yet, because antibiotics are used to treat infections, it is important not to potentially increase the level of antibiotic resistance among microorganisms in the external environment.

Recognising this potential risk, and extending our precautionary approach, it is Novo Nordisk’s policy, wherever possible, to avoid the use of genes coding for antibiotic resistance when developing new production strains. A new modified yeast strain in which the gene coding for antibiotic resistance was successfully removed was tested in production in 2002 and will eventually substitute the existing insulin production strain when
the health authorities have approved its use.

Natural microorganisms can potentially be contaminated with antibiotic resistance genes via the disposal of waste products, especially yeast cream. An improved yeast cream process to ensure optimal degradation of the antibiotic resistance genes will be implemented in 2003.