It is expected that gene technology can help solve many health issues of today, but it is also recognised that gene technology causes concerns to many people.
Novo Nordisk uses gene technology and GMOs in biomedical research and in the production and analysis of pharmaceuticals. The GMOs are handled under controlled, contained conditions.
The GMOs in use for research and production at Novo Nordisk are mainly microorganisms (i.e. fungi and bacteria) and mammalian cells. After the first cultivation step using GMOs, the product of interest is separated from the production organisms in a multi-step downstream purification process, which ensures complete removal of the GMOs or fragments thereof, including residual DNA.
For production, Novo Nordisk uses GMOs in the lowest risk category where there is no known risk to humans or to the environment. Equally, in research Novo Nordisk strives to use the lowest possible risk category of GMOs.
In the case of an accidental release of GMOs used in production at Novo Nordisk, there is no known risk to humans and the surrounding environment. The highly modified GMOs are designed for production in a well-controlled production environment where the special nutritional (e.g. sugars and vitamins) and biophysical (e.g. pH and temperature) conditions are optimised for the individual organism. The GMOs’ special nutritional and biophysical requirements will prevent their survival in the environment, which presents suboptimal conditions with scarce nutrients and competition from naturally occurring microorganisms.
Novo Nordisk´s main usage of GMOs is in Denmark. Novo Nordisk must, like all other companies in Denmark, obtain approval before starting any kind of experiment or production involving GMOs. In Denmark, the approval is given by the National Working Environment Authority and in the case of production also by the Danish Forest and Nature Agency. Outside Denmark, Novo Nordisk operates under the high ethical standards of the company in addition to local regulations on GMOs.
The potential risk to employees and the environment during normal procedures as well as in the case of accidents or spills is carefully considered. The laboratory and production facilities where the GMOs are handled must be approved by the authorities before use. All GMOs are handled under contained conditions and by trained personnel according to approved procedures.
Contained use of approved GMOs for research and production in Novo Nordisk is based on more than 25 years of risk assessments and safety records. No damage to human health or the environment has ever been recorded. Field surveys have not shown living GMOs in the surrounding soil. Nevertheless, Novo Nordisk continuously aims at eliminating and reducing uncertainties and at developing additional precautionary approaches.
The use of antibiotic resistance genes as markers in GMOs raises public concern. Over the years, many studies and control measures have shown that Novo Nordisk’s production using GMOs with antibiotic resistance marker genes does not contribute to the spread of antibiotic resistance in the external environment. Novo Nordisk treats its waste so as to eliminate living recombinant organisms and functional DNA. Even so, it has been decided that, whenever technically possible and practically feasible, all new production strains will be developed without genetically engineered antibiotic resistance marker genes as a precautionary approach, in response to public concerns.
As the debate on GMOs develops, Novo Nordisk will continuously try to respond to the concerns of society through open communication and dialogue and by integrating these concerns into our daily decision-making.
Novo Nordisk’s pharmaceutical products are based on the use of GMOs. The raw material used is selected based on the quality specifications and the process requirements. Novo Nordisk is currently monitoring its use of raw material of genetically modified origin in production, and the use will be limited to raw materials approved by the EU authorities for production in or import into the EU.
Senior Principal Scientist