Gene technology
Public concern is often seen in relation to genetic engineering, and in particular the ‘what ifs’ in connection with genetically modified organisms (GMOs) in foods or animal feed. Industry and the medical community are, on the other hand, generally perceived to obtain many advantages from applying this technology, including from a sustainability perspective.
With genetic engineering, organisms can be modified to produce valuable substances that would otherwise be in short supply, or even impossible to produce. These organisms can be further tailored to express more specific pharmaceutical molecules and be more productive. One such example is modern insulins (insulin analogues) that are based on engineered baker’s yeast.
Without genetic engineering it would not be possible to provide NovoSeven®, which is the only treatment for people with haemophilia with inhibitors, or to produce a sufficient and stable supply of high-quality insulin to meet current and growing demands. Potential risks involved with the application of gene technology are routinely assessed.
Novo Nordisk monitors and takes an active part in the development of international standards for genetic engineering, seeking to help inform legislative initiatives.
How Novo Nordisk uses gene technology
Novo Nordisk uses gene technology and genetically 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. 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.
Novo Nordisk’s technology is based on microbial fermentation of genetically modified yeast, E.coli bacteria and mammalian cells. For each product, Novo Nordisk develops specific genetically modified cell lines. DNA carrying the genetic codes for the therapeutic proteins of interest is inserted into the cells. The cells expressing and, in most cases, secreting the pharmaceutical products are transferred into large-scale growth facilities for production. The product is subsequently separated from the cells and transferred to the final recovery and purification processes.
The main raw materials used in Novo Nordisk’s closed fermentation tanks are water, nutrients and sugar. During the recovery and purification processes, Novo Nordisk use organic chemicals (such as ethanol), inorganic chemicals (such as acids, bases and salts), and filter materials (such as kieselgel). Some of the processes include antibody affinity purification of the pharmaceutical product, and enzymatic maturation is applied in Novo Nordisk’s insulin production.
The main waste product from Novo Nordisk’s insulin 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 undergoes heat treatment to ensure that all microorganisms are killed.
Over the years Novo Nordisk has optimised the use of resources in the development of new insulin analogues. Using a new yeast strain, Novo Nordisk is 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.
Novo Nordisk’s approach
It is Novo Nordisk’s goal to optimise the use of genetic engineering in the manufacturing of the company’s products, not only to ensure high-quality and efficient production at Novo Nordisk’s sites, but also as a benefit to the environment. See Novo Nordisk's position on gene technology.
Novo Nordisk recognises the concerns associated with the use of genetic engineering and take a precautionary approach to the use of this technology. Novo Nordisk realises that safety and ethics are important in managing modern biotechnology. National laws regulate the use of genetically modified microorganisms for production purposes with the aim of protecting human health and the environment from any adverse effects. Novo Nordisk seeks to stay attuned to public concerns over GMOs by engaging in an open, honest and transparent dialogue with stakeholders.
Eliminating marker genes
In genetic engineering, specific uses of gene 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 Novo Nordisk’s 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.
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.
This page has been reviewed by PricewaterhouseCoopers as part of its assurance of Novo Nordisk’s non-financial reporting. Please refer to Audit and assurance for a full description of the conclusions and the nature of assurance offered.
