Navigation Links
'Growing' medicines in plants requires new regulations

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

In a paper to be published in Current Pharmaceutical Design, six scientists from the US and Europe compare risk assessment and regulation between the two continents. They will run a web chat on the subject with Sense About Science 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".

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 needed to consider issues with environmental release and the ultimate use by humans. Measures can include those adopted 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.


Contact: Zoe Dunford
Norwich BioScience Institutes

Related medicine news :

1. Package All Corporation Keeps on Growing with Expanded Distribution Centers and Services to Keep Customers' Packaging Lines Moving
2. Dr. Sam Speron Verifies the Growing Trend of Daddy Makeovers
3. Flame Retardant Chemicals Market growing at a CAGR of 6.9% & to reach $7,131.9 Million by 2017 - New Report by MarketsandMarkets
4. 1,4-butanediol (BDO) Market is growing at a CAGR of 5.5% & to reach $7.5 Billion by 2017 - New Report by MarketsandMarkets
5. Muscular Development Store Responds to the Growing Trend of Weightlifting Among Teen Girls
6. Fast Growing Demand for Email Address Validation: Byteplant Expands its Capacities for Batch Email Address Validation and the Online API
7. Fast Growing San Francisco Chiropractic Clinic Welcomes New Doctor, Dr. Anthony Gustin
8. New study highlights Chagas disease as a growing health and socio-economic challenge
9. Transvaginal Mesh Lawsuit Website Launched by Bernstein Liebhard LLP Provides Updated Information on Vaginal Mesh Side Effects, Growing Litigation
10. New NIH resources help growing number of Americans with vision loss
11. Airports Baggage Handling Systems Market is Growing at an Estimated CAGR of 7.08% & to Reach $30.66 Billion by 2017 - New Report by MarketsandMarkets
Post Your Comments:
(Date:10/13/2017)... ... 2017 , ... PurhealthRX , a leading Health and Nutrition Company, is ... to full spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing ... easily incorporated into liquid products, while reducing costs to end users. , The team ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released a ... books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture of ... have tossed it off as mere rubbish, but Yisrayl Hawkins says that is because ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, ... 8th Day Software and Consulting, LLC , and named ... 8th Day Software, based in Tennessee , ... 8th Day expands EnvoyHealth,s service offerings for health care ... "In an interoperable ...
Breaking Medicine Technology: