Genetic modification of cells and organisms presents a unique opportunity to increase the possibility of offering safe and efficacious medical help for patients.
The use of gene technology in biomedical research and the use of GMOs in the production of pharmaceuticals offer substantial benefits to the quality of products, the environment and opportunities for the identification of new treatment concepts for patients.
1 Contained use of gene technology
We find that the contained use of gene technology is an
important tool in the identification, development, and production of
pharmaceuticals for patients. These pharmaceuticals could not
otherwise be provided in sufficient quantity or quality.
2 Use of GMOs
We only use GMOs in the lowest risk category for production and
the final polypeptide products do not contain genetically modified
cells or genes. However, use of modified genetic sequences have great
potential in treatment of serious chronic diseases. To unharness this
potential, genetically modified elements may form essential components
of future products aiming to correct genetic diseases.
3 Antibiotic resistance genes
We use production strains without antibiotic resistance genes
whenever technically possible and practically feasible.
4 Accidental release of GMOs
We recognise the concern about accidental release of GMOs to
the environment and has implemented appropriate measures to ensure
compliance with regulations set by the authorities.
5 Regulation and public concerns
We support the proper regulation of the use of gene technology
and the principle that public concerns are adequately addressed.
6 Precautionary principle
We apply the Precautionary Principle in the use of gene
technology by conducting risk assessments prior to use.
7 International standards
We actively participate in the development of relevant
international standards for gene technology.
8 Transparency and openness
We support transparency and openness in relation to the use of
gene technology and continue to report publicly on our use of the technology.
“The genetically modified cells in our production are created in a laboratory and only intended for production in a protected and controlled environment. This means that the cells are very weak. It will take a number of very unusual incidents for our GMOs to survive in nature.”
Asser Sloth Andersen
M.Sc. in molecular biology
Novo Nordisk
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, for instance various types of insulin for the treatment of diabetes, hormones for the treatment of growth disorders, and blood clotting factors for the treatment of haemophilia.
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. We only use GMOs in the lowest risk category for production of our polypeptide products.
Genetically modified organisms and elements thereof will be a necessary component of future curative therapies. We only use GMOs in the lowest risk category for production of our polypeptide products.
Novo Nordisk's production of polypeptides is based on GMOs in a contained environment. This means that all substances and fluids containing GMOs are kept in closed pipes and tanks throughout the entire production process. 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, from the polypeptide product.
For polypeptide 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.
Gene therapy has great potential to provide curative treatments for chronic diseases. Genetically modified organisms and elements thereof will be a necessary component for such therapies. We are committed to patient safety and environmental responsibility and strive to use GMOs of the lowest possible risk category for a given application.
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 30 years of risk assessments and safety records. No damage to human health or the environment has ever been recorded.
This has enabled us to reduce the consumption of water, energy and raw materials per produced unit.
The main waste product is an organic material known as yeast sludge, which is recycled as raw material for biogas generation.
New cell line selection systems without antibiotic resistance markers and use of antibiotics are being implemented, and antibiotics consumption for existing, old products and enzymes is reduced by a factor of 2-10 over the last years.
We consider gene therapy and therapeutic editing to be important in the development of novel treatments for chronic diseases and other diseases with unmet medical need. These technologies have potential to offer treatment quality beyond what can be achieved with traditional modalities.
See more in the Cell Therapy Ethics section
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