tobacco plant; John Innes Centre; molecular farming; monoclonal antibody; HIV

“Growing” medicines in plants requires new regulations

“Growing” medicines in plants requires new regulations

Scientists say amending an EU directive on GMOs could help stimulate innovation in making cheaper vaccines, pharmaceuticals and organic plastics using plants.

In a paper to be published in Current Pharmaceutical Design, six scientists from the US and Europe, including Dr Penny

Penny Sparrow; John Innes Centre; molecular farming

Dr Penny Sparrow

Sparrow from the John Innes Centre, compare risk assessment and regulation between the two continents. Sense About Science will run a live Q&A on the subject from 12-1 on Wednesday 20th February.

In the EU, plant-made pharmaceuticals have to be authorised in the same way as GM agricultural crops. In theory, agricultural crops can be grown by any farmer in the EU once approved. But for crops producing pharmaceuticals this would never actually happen. Drug companies would likely license farmers to grow these crops under controlled, defined and confined conditions.

“We need tight regulations enforced by continuous oversight to encourage investment, while maintaining trust,” said Dr Penny Sparrow from the John Innes Centre.

“This will be of high importance, especially in Europe, where the issues surrounding the cultivation of GM agricultural crops remains a contentious concern.”

“Plant-made pharmaceuticals challenge two sets of existing EU regulations and to make progress in this area we need to make sure they are applied sensibly to allow pharmaceuticals to be produced in plants.”

Advantages of using plants to produce therapeutic proteins include the ability to produce large quantities quickly and cheaply, the absence of human pathogens, the stability of the proteins and the ease with which raw material can be stored as seed. This could be of huge benefit in developing countries where problems with storage can render vaccines useless.

If seed could be transported to local production and extraction facilities, the technology could also help boost local economies. The technology is also known as “plant molecular farming”.

tobacco; monoclonal antibody; Dr Penny Sparrow; John Innes Centre

Tobacco plants grown in containment to produce an anti-HIV monoclonal antibody. Credit: Stefan Schillberg, Fraunhofer IME

Just one farm growing 16,000 acres of safflower could meet the world’s total demand for insulin. But potential cost savings are eliminated under current regulations, set up for GM agricultural crops not pharmaceuticals.

The average cost for having GMOs approved in Europe is estimated at €7-10 million per event, compared to $1-2 million in the US. This helps keep Europe behind in exploiting the potential of these technologies.

“Openness and transparency are needed to develop new regulations that work for the public and for investors,” said Sparrow.

“Regulations need to be harmonised across the world, in order to keep advances and competition on a level playing field.”

They propose amendments to EU Directive 2001/18 to allow pharmaceutical products from GM plants to be commercialised without needing authorisation to enter the human food or animal feed chain. Instead, the scientists say they should be grown under clearly defined and enforced conditions to keep the food and animal feed chain ‘contamination free’.

As each GM plant moves from the laboratory to scaled-up production in a greenhouse or field, additional oversight is

monoclonal antibody; John Innes Centre; tobacco plants; molecular farming; Penny Sparrow

Tobacco plants grown in containment to produce a pharmaceutical protein. Credit: Stefan Schillberg, Fraunhofer IME

needed to consider issues with environmental release and the ultimate use by humans. Measures can include those developed and ready to be implemented in the US, such as limited acreage, confinement, fallow zones and only supplying seed to farmers specifically contracted to grow PMPs.

Dr Sparrow was involved in a collaboration with EU partners to road test the challenges faced by potential investors. They chose the first plant-derived anti-HIV monoclonal antibody to be tested in humans. It was isolated, purified and formulated as a topical saline solution. One result of the project was preparing a regulatory pathway that others could follow to take a product into clinical trials. Another was establishing good manufacturing practices for biologically active proteins expressed in transgenic plants.

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4 Responses to ““Growing” medicines in plants requires new regulations”

  1. Douglas Chamberlain August 1, 2013 at 10:16 pm

    I am curious about the tobacco plants pictured in this article expressing anti-HIV monoclonal antibodies.

    The company which I worked for ten years ago was a biotech and conventional wheat breeding company (Perth, Western Australia)and the conventional varieties produced were widely grown in Australia. I was the biotech Chief Scientist and we produced anti-CD4 and anti-CD28 monoclonals in GM wheat seed. Grain has particular transport and storage advantages. In collaboration with Flinders University Medical Centre (Adelaide)functional activity was demonstrated from crude grain extracts using thymocytes as target and the absence of endotoxins which plague the bacterial production system was quantitatively demonstrated.
    I was curious about the potential of the grain produced CD4 antibody in terms of blocking the HIV binding site on T cells as a preventative or treatment and also its use as a transportable, storable carrier of the antibody for use in CD4 counts in monitoring HIV progression and indicating the best time for anti-retroviral intervention. It would retain
    activity in seed sitting at glasshouse temperatures.
    Hence I wonder where this fits into the picture such as the anti-HIV tobacco one above?
    I became a bit frightened when the anti-CD28 trial in London became the “elephantmen trial”. However our anti-CD28 monoclonal was murine, whereas if I remember rightly the London trial involved hunmanised antibody that had been pre-tested in mice which seems a bit topsy turvey and in hindsight dangerous.

    Brereton, H.M., Chamberlain, D.A., Yang, R., Tea, M., McNeil, S., Coster, D.J. and Williams, K.A. (2007) Single chain antibody fragments for ocular use produced at high levels in a commercial wheat variety, Journal of Biotechnology 129 539-546.

    Thank you for any information

    Kind regards
    Doug Chamberlain

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