Genetic enginering

Some people are concerned about the risks associated with genetic engineering, and in particular the 'what ifs' in connection with genetically modified organisms (GMOs) in foods or animal feed. Industry, on the other hand, generally sees many advantages to this technology, including from a sustainability point of view.

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.

For Novo Nordisk, without genetic engineering it would not be possible to provide a sufficient and stable supply of high-quality insulin to meet demands.

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 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.

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 insulin analogues. Using a new yeast strain, we are able to substantially reduce the consumption of water, energy and raw materials per produced unit. These insulin products are produced at the site in Kalundborg, Denmark.

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.

See Novo Nordisk's position on gene technology.

We recognise the concerns over risks associated with genetic engineering and take a precautionary approach to the uses of this technology. We realise that safety and ethics are important 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 of protecting human health and the environment from any adverse effects.

Novo Nordisk uses gene technology and gentically modified organisms (GMOs) in biomedical research and the production of pharmaceuticals. The application of gene technology enables Novo Nordisk to produce a variety of biologically active proteins, various types of insulin for the treatment of diabetes, hormones for the treatment of growth deficiencies, and blood clotting factors for the treatment of haemophilia, strokes and trauma. The GMOs are handled under contained conditions. GMOs of the lowest risk category (Class 1) are used in the production of pharmaceuticals. Risk assessments are carried out prior to the use of GMOs for both research and production purposes. As a responsible company, Novo Nordisk has attuned itself to public concerns over GMOs by engaging in an open, honest and transparent dialogue with stakeholders.

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. However, because antibiotics are used to treat infections, it is important not to 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 has now substituted the existing insulin production strain.

To ensure that relevant GMO-related issues are handled in a coordinated and consistent manner across the organisation, Novo Nordisk established a GMO steering group in 2003 with cross-organisational representation. The GMO steering group reports to the Environment & Bioethics Committee.

In 2005 Novo Nordisk had one accidental release of materials containing GMOs; in September at the production site in Montes Claros, Brazil. The GMOs in question cannot survive outside their usual protected environment in the laboratory. It was found that there was no risk that the GMOs could spread to the external environment.

This page has been assessed by PricewaterhouseCoopers as part of its assessment of Novo Nordisk’s statement that it reports ‘in accordance’ with GRI. Please refer to Audit and assurance for a full description of the nature of assurance offered.