Genetically modified organisms (GMOs) are living cells or organisms which have been genetically modified for research or to produce specific pharmaceutical substances. A gene coding for a recombinant protein is inserted into a DNA molecule carrying all the genetic elements necessary for the cell to produce the protein of interest. The assembled DNA carrying the genetic codes for the therapeutic protein is then inserted into the cells, enabling them to produce the recombinant protein. Genetic modification of cells and organisms presents a unique opportunity to increase the possibility of offering safe and efficacious medical help for patients.
Novo Nordisk uses gene technology and GMOs in the research and production of pharmaceuticals. The application of gene technology enables us to produce a variety of biologically active proteins in large quantities, e.g. 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.
GMOs have been used in pharmaceutical production since the 1980’s. Novo Nordisk’s technology is based on the cultivation of genetically modified yeast, bacteria (E. coli) and mammalian cells. For each product, we develop specific genetically modified cell lines tailored to produce the specific protein needed.
Potential risks involved in the application of gene technology are thoroughly assessed at Novo Nordisk. Risk assessments are carried out prior to the use of GMOs for both research and production purposes, to remain compliant with regulations and the high Novo Nordisk standards. Our contained use of approved GMOs for research and production 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.
"We believe in openness when we deal with issues which cause public concern. We see it as our obligation to communicate on any issue with a perceived risk to society."
Arne Staby, Senior Principal Scientist and gene technology expert, CMC Development, Novo Nordisk
Historically Novo Nordisk had to collect insulin-producing cells from pig glands and turn it into insulin for humans. By using GMO-produced insulin it is possible to avoid the risk of transferring viruses from pigs to humans.
Without genetic engineering it would not be possible to produce NovoSeven®, which is the only recombinant treatment for people with haemophilia with inhibitors, or to produce a sufficient and stable supply of other high-quality products to meet current and growing demand.
When balancing the pros and cons regarding our use of GMOs, we find that the benefit of being able to develop and offer treatment to many patients by far outweighs the theoretical risks. Nevertheless, Novo Nordisk continuously aims at reducing any uncertainties and at developing additional precautionary approaches. We follow best practices and adhere to all regulations to eliminate and manage risks related to GMOs.