Navigation Links
'Growing' medicines in plants requires new regulations
Date:2/19/2013

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
zoe.dunford@jic.ac.uk
44-077-681-64185
Norwich BioScience Institutes
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, the leading ... with Tennessee Counseling Association. This new relationship allows TherapySites to continue ... Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited about ...
(Date:6/26/2016)... ... ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center for ... Table in Battle Creek, MI, where the rehabilitation facility is located. This annual celebration ... world’s leading providers of cereal and other breakfast foods. Its residents often refer to ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... CLEMENTE, Calif. , June 24, 2016  American Respiratory Labs ... company, is now able to perform sophisticated lung assessments in patients, ... Technologies , Inc. Patients are no longer limited ... ndd,s EasyOne PRO ® , ARL patients like Jeanne R. of ... done in the comfort of her own home. ...
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/24/2016)... , June 24, 2016 VolitionRx ... of Dr. Edward Futcher to the ... effective June 23, 2016.Dr. Futcher was also appointed ... Governance Committees.  As a non-executive member of the ... and strategic counsel to VolitionRx in connection with ...
Breaking Medicine Technology: