PUBLISHED BY SABIC: SASKATCHEWAN ... - Ag-West Bio Inc.

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Dec 1, 2012 (4 years and 6 months ago)

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A P R I L 2 0 0 3



ISSUE 83



AgBiotech


INFOSOURCE


PUBLISHED BY SABIC: SASKATCHEWAN AGRICULTURAL BIOTECHNOLOGY INFORMATION CENTRE

A SERVICE OF AG
-
WEST BIOTECH INC.

PMPs
-

Plant
-
Made Pharmaceuticals


Plant molecular farming, one application of biot
echnology, involves growing and
harvesting genetically modified crops for the production of biological pharmaceuticals or
industrial materials. These plants are not produced for food, feed, or other agricultural
commodities, but rather become bio
-
factories

that can produce proteins that are difficult
or expensive to make by other means. The proteins themselves are used in the production
of therapeutic drugs and for certain industrial materials, such as bioplastics.

Pharmaceuticals made in plant
-
factories ar
e also known as Plant
-
Made Pharmaceuticals
(PMPs). PMPs can be new, critically needed drugs, or widely used generic drugs. Their
active element is usually a protein too complex to be produced by the usual chemical
synthesis technologies. In order to produc
e such proteins, genetically transformed living
organisms, like cells in culture, transgenic animals, or plant
-
factories, must be used. It is
estimated that in 2010 PMPs might represent up to 35% of drugs sold.

The plant connection

Since the 1980’s, new th
erapies called ‘biologics’ have been developed by the best
pharmaceutical and research labs of the world to help cure cancer, arthritis, heart
conditions and other severe or chronic diseases. However, current production methods
are insufficient, and some o
f these novel drugs may never even reach the patient because
of excessive costs or lack of production capacity.

Plants offer an effective and economical way to produce these valuable products.
Through genetic engineering, they can be transformed to produce

a wider variety of more
suitable antibodies than bacteria and at higher concentrations. The harnessing of gene
technology allows plants to be turned into factories for medicines and other value
-
added
commodities. Combining plant genetics, molecular biolog
y, and gene delivery systems,
genes can be taken from other sources, such as microorganisms, and spliced into a plant’s
genome. During normal growth these genetically engineered plants synthesize
‘recombinant’ proteins, which can be therapeutics, vaccines,

blood substitutes, enzymes,
monoclonal antibodies, or diagnostics that are then extracted from the crop.

Plants will allow for large
-
scale production capacity at a cost that could be much lower
than current manufacturing methods. They also allow for rapid

scale
-
up of production. If
demand for a new PMP increases more fields can be planted. Another advantage is that
plants do not carry human diseases, reducing the risk of drugs being contaminated with
animal pathogens, prions, or disease
-
causing germs.

Appl
ication

There are currently over 50 human therapeutic products being produced in plant and
animals that are in or are close to being ready for clinical human trials. Among those in
development are therapeutics for: Alzheimer’s Disease, cancer, cholera, Cys
tic Fibrosis,
heart disease, Hepatitis B, HIV, Multiple Sclerosis, obesity, rheumatoid arthritis, spinal
cord injuries, tooth decay and many others (see Table 1).


Table 1:

Examples of current Plant
-
Made Pharmaceutical research


Alfalfa

Plasma proteins

Ar
abidopsis

Human intrinsic factor (vitamin B12 uptake)

Corn

Anti
-
HIV and anti
-
Herpes simplex antibodies

Microbicides for pulmonary infection

MABs for cancer, arthritis, and other auto
-
immune diseases like
Crohn’s disease

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on and Traveler’s disease

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䅰A潴o湩渠景n⁢汯潤潳猠慮搠桥a牴⁳畲来ry

噡cc楮e猠s湤⁡湴n扯摩敳b景f⁡湩na氠摩獥ase⁰牥ve湴n潮

䅮瑩扯摩es

ie浭a

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䅬灨A⁩湴e牦e牯r

䵯獳

cac瑯爠f堠uo爠瑲e
a瑭e湴映桡e浯灨m汩a⁂

o楣i

䅬瑥A湡瑩癥猠瑯⁡湴s扩潴楣猠楮⁰潵i瑲y⁤楥瑳

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楮晬i浭a瑩潮o

pa晦汯睥r

m桡牭rce畴uca汳⁡湤楬
-
扯by
-
ba獥搠灲d摵c瑳⁦潲 潲o氠慮搠摥牭r氠
摥汩癥ry

p灩湡ph

m牯瑥c瑩癥⁡n
瑩来渠景n⁶acc楮攠i条楮獴
Baccillus anthracis

Tobacco

TGF
-


glucocerebrosidase for Gaucher’s disease

Ca湣e爠racc楮e⁦潲潮
-
Hodgkin’s lymphoma

䅬灨A⁧ 污l瑯獩摡se⁦潲 e湺yme⁲ 灬pce浥湴⁴桥牡py

f杇猠景f⁴桥⁰牥癥湴n潮映摥湴慬⁤ncayⰠ灲e癥湴no渠潦⁣潭o潮

c潬搬⁡湤o畴牡汩za瑩潮o⁣桥浯m桥ra灥畴uc⁤牵g 瑯t楣楴y

䝁䐠㜠ay瑯歩湥猠景爠rype‱⁄楡扥瑥t


-
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呯扡cc漬oc潲o

䝡獴物挠汩灡獥⁦ 爠ry獴sc⁦楢牯獩i

iac瑯晥牲楮⁦潲 条獴牯
-
楮i
e獴s湡氠l湦nc瑩潮⁡湤⁤ny eye⁳y湤牯浥

呯浡瑯Ⱐ灯ta瑯t

m潴慴漠瑵扥o

䕤楢be⁶ cc楮敳iaga楮獴
E.coli
, Norwalk virus, Hepatitis B
Antimicrobial peptides




New technologies and safety

Like any new technology there are concerns to deal with and precautions t
o take. For
example, plants with novel traits for molecular farming may be considered unsafe for the
environment if a novel compound is produced that may be toxic or inhibitory to wildlife.
They may also be considered unsafe for the environment if the nove
l trait can be
transferred to other plants of the same or related species. Some plants used for molecular
farming may produce compounds (such as pharmaceuticals) that affect human or
livestock health.

Measures will have to be taken when growing plants cont
aining therapeutic agents to
ensure they do not get into the regular food or animal feed supplies. They will have to be
fully contained and will probably be grown in non
-
food crops such as certain weed
species.

In Canada, the government recognizes that, in

order to secure the benefits of
biotechnology and molecular farming, it is essential to first protect the health and safety
of Canadians, the environment, the food supply, and animals.

Canada has a well
-
balanced stewardship approach, the cornerstone of wh
ich is the
Federal Regulatory Framework for Biotechnology. This framework provides a
transparent and rigorous regulatory system, based on the best available science. This is to
ensure Canadians have confidence in, and benefit from, safe and effective biote
chnology
-
based products and services, including those associated with PMPs. In Canada, the
responsibility of regulating molecular farming is shared by the Canadian Food Inspection
Agency, Health Canada, and Environment Canada.

Researchers, government regul
ators, and industry are working together to develop a
regulatory system that will ensure the safety of Canadians and our food supply while at
the same time will allow the new technology. A technology that can have tremendous
benefits for human and animal h
ealth.


For more information:

National Research Council


Plant Biotechnology Institute:

http://www.pbi.nrc.ca/en/media/advance3a.htm

Canadian Food Inspection Agency:

http://www.inspection.gc.ca/english/plaveg/pbo/mf/mf_pharme.shtml

Biotechnology Industry
Organization:

PMP page:
http://www.bio.org/pmp/

Consumer benefits:
http://www.bio.org/pmp/PMPBenefits.pdf



To find out more about agricultural biotechnology or to book a tour of the Saskatchewan
Agricultural Biotechnology Information Centre (SABIC), cont
act:


Ag
-
West Biotech Inc.

101
-
111 Research Drive

Saskatoon, Saskatchewan


Canada S7N 3R2

Tel.: 306
-
668
-
2660


Fax: 306
-
975
-
1966

E
-
mail:
sabic@agwest.sk.ca

Web site:
http://
www.agwest.sk.ca/




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-
West Biotech Inc.

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Revitalization.