Reduce, refine and replace animal experiments
Novo Nordisk has a long history of engaging with stakeholders such as animal welfare organisations to find solutions for improving the welfare of experimental animals. Novo Nordisk recognises that not all animal experiments can be replaced in the foreseeable future, but we will only use animals where no available and acceptable alternative exists. Novo Nordisk actively supports the principle of The Three Rs: to Reduce, Refine, and Replace animal experiments, and has been setting new standards in this area. One example is our state-of-the-art housing standards for dogs and rabbits.
Removal of biological test types
During the last decade Novo Nordisk has succeeded in achieving regulatory approval for the total removal of all biological test types for product control in most countries. Only two test types remain to be removed to fully eliminate the use of laboratory animals for production control.
It has not been possible to obtain acceptance from authorities in all countries to omit viral testing in animals for production of NovoSeven®. Novo Nordisk has therefore been forced to resume animal testing of NovoSeven® production to be able to deliver the product to customers. A strategy has been developed to remove this test type by 2010.
A novel in-vitro bioassay has been developed and is planned to be implemented during 2010 to fully replace the present insulin bioidentity test in rabbits.
Pioneer in biosimulation
Through the use of modelled drug experiments, Novo Nordisk has not only made drug experiments more efficient, computer models have also reduced the number of tests in animals as well as in humans. Indeed, Novo Nordisk is a frontrunner of computerised simulations of drug experiments - also known as biosimulations – a tool which proves to have both cost beneficial and competitive advantages.
In 2009 Novo Nordisk successfully used computer models to evaluate and interpret data obtained from animal experiments and clinical research.
As a partner in the EU Network of Excellence in BioSim, Novo Nordisk has contributed to the further development of BioSim as a new tool in drug development and dissemination of the network’s activities. Novo Nordisk has helped evaluate how BioSim can contribute to future drug development and support the principles of the Three Rs.
Number of animals purchased in 2009
| Species |
Inhouse
in
Denmark |
Inhouse
outside
Denmark |
Novo
Nordisk
Total |
Contract
Research
Org. |
Total |
|
| Mice |
20.474 |
68 |
20.542 |
3.359 |
23.901 |
| Genetic modified mice |
7.270 |
0 |
7.270 |
1.185 |
8.455 |
|
| Rats |
17.072 |
0 |
17.072 |
5.286 |
22.358 |
| Guinea pigs |
24 |
0 |
24 |
60 |
84 |
| Hamsters |
0 |
0 |
0 |
6 |
6 |
| Rabbits |
479 |
0 |
479 |
80 |
559 |
| Transgenic rabbits |
|
|
0 |
|
0 |
| Sheep |
|
|
0 |
|
0 |
| Transgenic sheep |
|
|
0 |
|
0 |
| Pigs |
672 |
0 |
672 |
498 |
1.170 |
|
| Dogs |
44 |
0 |
44 |
196 |
240 |
| Non-human primates |
0 |
0 |
0 |
540 |
540 |
| Goats |
1 |
0 |
1 |
1 |
2 |
|
| Other vertebrates* |
0 |
0 |
0 |
0 |
0 |
|
| Total |
46.036 |
68 |
46.104 |
11.211 |
57.315
|
(Contract Research Org. = Contract Research Organisations)
* Other vertebrates are fish, chickens and frogs
The total number of animals purchased by Novo Nordisk in 2009 compared to 2008 is very similar with 57,315 animals purchased in 2009 compared to 57,253 animals in 2008.
Split into species, the only significant change in number is the increased number of purchased pigs from 808 in 2008 to 1,170 in 2009, which is due to the increased number of diabetes studies in which pigs are the most suitable large animal model.
For the first time, in-house animal studies are performed outside Denmark, as the animal facility at NNST, Beijing, China opened in March 2009 – and in 2009 used 68 mice in immunisation studies.
In general, the use of animals at external contractors has decreased from 14,486 animals in 2008 to 11,211 animals in 2009, which partly is due to a decreased number of external regulatory toxicology and safety studies and a wish to perform more in-house animal studies.
Animal facility opened in Beijing
The final inspection and opening of NNST animal facility (Novo Nordisk China R&D Centre), Beijing, China was performed by Animal Unit, Management, Denmark on 3 March 2009 and found to be in compliance with Novo Nordisk global animal welfare standards and expectations and was thereby approved for internal Novo Nordisk mouse studies.
The animal facility has furthermore been approved by the local Chinese authorities for mice, rat, and rabbit studies for a five-year period starting 2009 and permission has been obtained to perform animal experimentation.
All animal studies will be performed according to Novo Nordisk global animal welfare standards, with the overall responsibility of the Animal Unit, Management, Denmark.
Novo Nordisk 3R Award, 2009
As an initiative from the Novo Nordisk Ethical Review Committee (ERC), Animal Unit, and R&D Bioethics Board, the first Novo Nordisk 3R Award was held 22 October 2009 in order to share and exchange ideas and initiatives in relation to 3R (reduction, replacement, and refinement).
Ten submitted 3R initiatives from the animal research organization were selected for presentation. The award committee headed by an external animal welfare specialist gave the first prize and award to a collaborative project between the Animal Unit, Ganløse, Diabetes Research Unit and Diabetes Toxicology and Safety Pharmacology for their initiative concerning an improved method of subcutaneous dosing in mini-pigs which already has been shared with external partners as well as being introduced at the Novo Nordisk pig facility.