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:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The ... published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations at ... Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners ... extensive sequencing and genomics experience, as Vice President of North American Capital Sales at ... responsible for leading the sales team in the commercialization of the HTG EdgeSeq system ...
(Date:6/24/2016)... ... 24, 2016 , ... Today, MTI-GlobalStem, a provider of optimized ... difficult to transfect cells, announces its launch of the PluriQ™ G9™ Gene Editing ... is a complete system for culturing and transfecting human pluripotent stem cells ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... June 23, 2016 , , ... July 7, 2016 , , , , LOCATION: , , ... , , , EXPERT PANELISTS:  , , , Frost & ... Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, ... The global pharmaceutical industry is witnessing an exceptional era. Several new ...
(Date:6/23/2016)... -- Guerbet announced today that it has been named a ... One of 12 suppliers to receive the ... of Premier members through exceptional local customer service and ... lower costs. "We ... customer service from Premier," says Massimo Carrara , ...
Breaking Medicine Technology: