Transgenic Livestock Programme: Frequently Asked Questions (FAQ)

What is different about the milk produced by AgResearch’s transgenic animals compared to milk from ordinary animals?

Milk from some of the transgenic herd contains a human protein that does not exist in milk from ordinary dairy cows. This protein is present because of genetic modification prior to the breeding of the first animals in AgResearch’s transgenic herd.  Research has demonstrated that the modification that produces the proteins is retained through successive generations, and that the protein could be extracted, purified and used to produce pharmaceuticals to combat disease in humans.

Why are human genes used in the research?

The purpose of this research is to produce therapeutic proteins which will be used to treat specific human diseases. In most cases proteins produced from human genes are best suited to treat humans and are therefore the logical choice to be used in this work. Usually, there are no natural sources of these proteins, other than from humans, that would allow sufficient quantities to be available to meet demand. The production of therapeutic proteins in milk using this technology enables commercial volumes to be produced in a very cost competitive manner, without causing any harm to the animal or the environment. This will result in currently expensive pharmaceutical products being made available to the medical world at substantially lower costs, thus allowing greater access for patients.

Can the biopharmaceuticals produced from the proteins expressed in the milk of transgenic animals be produced any other way?

Yes. Most proteins can be produced using a range of different production systems, the most common being cell culture systems (often termed bioreactor systems). These are essentially cells, mammalian, bacterial or fungal, which have the gene coding for the protein of choice inserted into their DNA. The cells are grown in large stainless steel tanks – ‘man-made’ bioreactor vessels – as opposed to animals which can be viewed as ‘natural’ bioreactors.

There are several advantages to using animals as the production ‘vessel’:

• Animals are able to produce large quantities of these proteins in their milk, so production is very efficient and cost competitive. The volumes of these biopharmaceutical products required globally can be produced from the milk of a relatively small number of transgenic animals.

• There is no harm to the animals. The animals are looked after extremely well and in a commercial setting would graze and be milked in the same way as dairy herds.

• This is a very flexible system. Animals can be bred as required, enabling fast upscaling to meet market demand, compared to investment in expensive infrastructure required in current cell culture production systems.

• The proteins produced are superior. Transgenic animals are able to produce highly complex proteins that cannot be produced by other systems and closely resemble the protein produced naturally in the human body.

Where will the research and production farms be located?

AgResearch currently operates a research farm at Ruakura, near Hamilton, which has a MAF certified animal containment facility in which all animals and animal products involved in genetic modification research are housed. For the foreseeable future the research will be undertaken at this site. No locations have yet been determined for commercial scale farming operations.

What are the benefits?

This transgenic approach provides the opportunity to produce recombinant (genetically modified) forms of proteins that are difficult to produce in economically viable quantities using conventional systems. This will enable the foundations of a new cutting-edge biotechnology-based biopharmaceutical industry to be developed in New Zealand. The biopharmaceutical market, still in its infancy, is experiencing huge growth globally and there is significant potential for new industry opportunities, within New Zealand, aligned to the technology.  The technology could also be used in the same way in New Zealand’s nutraceutical industry. Nutraceuticals are foods that provide medical or health benefits.

Downstream advantages include new industry start-ups and employment opportunities as well as attracting other global entities to invest in the New Zealand biotechnology industry. Such work can also offer flow-on benefits to other industry sectors, such as long-term value for the dairy industry by revolutionising methods of protein production.

Why is AgResearch involved in this work?

The proposal aligns with AgResearch’s objectives to raise the rate of productivity growth in the New Zealand pastoral sector and to introduce a range of biotechnologies and other technologies to New Zealand resulting in increased export revenue for New Zealand. These objectives are fundamental to the AgResearch charter and reflect the fact that New Zealand has depended on the pastoral sector for the majority of its export earnings for over a century. There is every reason to believe that the importance of the sector will remain.

Have trials been done on humans to test products from your transgenic herd’s milk already?

No trials of products from our transgenic herd’s milk have been carried out in humans.

Have any biopharmaceuticals been approved for use elsewhere?

A drug, ATryn®, purified from the milk of transgenic goats (produced in the USA), has undergone human clinical trials and is the first transgenically produced biopharmaceutical in the world approved for human use. It was approved for use in Europe in 2006 and is currently undergoing clinical trials for FDA registration in the USA.

What does AgResearch plan to do if the approvals are granted?

If ERMA approvals are granted, AgResearch will develop and refine the technology for producing, extracting and purifying targeted proteins of interest, establish standards that will meet regulatory requirements, and then work with targeted pharmaceutical companies, who will be responsible for the pre-clinical and human clinical work required to get regulatory approval.

Will milk produced by genetically modified animals enter the food chain?

For the research and development activities no milk or milk products will enter the food chain. All milk from the transgenic herd is currently disposed of within AgResearch’s containment unit. The milk is treated via fermentation (to pH 4 which destroys cells), diluted then disposed of by irrigation - it is sprayed onto land for which resource consent has been gained.

When the commercial viability of proteins and milk products has been established, further approvals from other regulatory agencies such as the New Zealand Food Safety Authority (for food) or Medsafe (for medicines) will be required before the products can enter the food or medicine market in New Zealand. The proposals in the 2008 application do not cover these other approvals as ERMA does not regulate food and medicines that don’t contain live organisms (these products are unlikely to contain live organisms). At some point in the future, if all regulatory approvals have been obtained, milk products marketed as functional foods or nutraceuticals may legitimately be available for human consumption or as a human medicine.

How will this impact on New Zealand’s environmental and agricultural reputation internationally?

New Zealand is respected internationally as a very efficient producer of quality dairy products produced from healthy, grass-fed animals grown in a sustainable, free-range environment. This work will not change that situation. The New Zealand agriculture industry is also seen as innovative and research-driven. Our developments in forage plants, disease and pest control, and stock quality have long led the world.

Other countries that our dairy exports compete with internationally are expanding their science to produce human health and nutrition ingredients from transgenic livestock. AgResearch’s work in this area will enhance our reputation for research-driven innovation in pastoral industries.

Will AgResearch move transgenic animals to other sites?

If, during the course of the research project it is deemed appropriate to move transgenic animals to other sites in other areas of the country, AgResearch will register and operate these in accordance with the appropriate ERMA/MAF regulations. The MAF facility registration process would require AgResearch to consult with neighbours and other affected parties. AgResearch would also set up community liaison groups where local communities and Iwi would be informed as to the activities undertaken at the respective sites.

Has AgResearch consulted with Maori?

Yes. AgResearch has consulted with Maori through a series of hui. AgResearch received and documented a diverse range of views which has been provided to ERMA. AgResearch has endeavoured to accommodate these perspectives and requests from Maori in its proposed programme.