biopharming plants and animal both

1. BIOPHARMING
II MSc MICROBIOLOGY(3RD SEM)
ANUSHREE GUPTA, G BALA TRIPURA, MAIBAM YAISANA CHANU,
SHALOYANA MOHANTHY, URVI SHARMA

2. INTRODUCTION
• Pharming, a portmanteau of "farming" and "pharmaceutical.
• Biopharming is the production and use of transgenic plants and animals genetically
engineered to produce pharmaceutical substances for use in humans or animals.
• It often involves the insertion of gene constructs derived from humans.
• The products of pharming are recombinant proteins or their metabolic products.
Recombinant proteins are most commonly produced using bacteria or yeast in a bioreactor,
but pharming offers the advantage to the producer that it does not require expensive
infrastructure, and production capacity can be quickly scaled to meet demand, at greatly
reduced cost.[
• For example, genetically modified yeast, bacteria, and animal cell cultures have for some
time been used to produce pharmaceutical substances in enclosed bioreactor systems, but
are generally not included in the definition of biopharming.

3. • On the other hand, plant cell cultures, a newer development but also
involving enclosed bioreactors, are typically included together with whole-
plant methods in plant biopharming
• While animals are also being genetically modified to alter their nutritional
composition, to make them better models for human disease, and to provide
more compatible organs for transplantation into humans, these are typically
excluded from the definition of biopharming.

4. HISTORY
• Biopharming has been carried out experimentally for more than 20 years.
• Biopharming has not been widely discussed in the popular media, even though it
has been implicated in several genetic-modification controversies. The animal
who became known as Stier Herman (Herman the Bull), the first transgenic
bovine, was a biopharm animal produced in the Netherlands in 1990 and
modified with the human gene for producing lactoferrin.
• The first recombinant plant-derived protein (PDP) was human serum albumin,
initially produced in 1990 in transgenic tobacco and potato plants.
• Open field growing trials of these crops began in the United States in 1992 and
have taken place every year since. While the United States Department of
Agriculture has approved planting of pharma crops in every state, most testing
has taken place in Hawaii, Nebraska, Iowa, and Wisconsin.

5. YEAR DEVELOPMENT REFERENCE
1986 First plant derived
recombinant therapeutic
protein human GH in
tobacco & sunflower
A Barta, D. Thompson
et al
1989 First plant derived
recombinant antibody full
sized IgG in tobacco
A.Haitt,K.Bowdish
1990 First native human protein
produced in plants –
human serum albumin in
tobacco & potato
P.C.Sijmons et al
1992 First plant derived vaccine
candidate- hepatitis B
H.S.Meson, D.M.Lam
1995 Secretory IgA produced in
tobacco
J.K.Ma, A.Hatt, M.Hein et
al
1996 First plant derived protein
polymer artificial elastin in
tobacco
X. Zhang, D.W. Urry, H.
Daniel

6. 1997 Commercial
production of avidin in
maize
E.E.Hood et al
2000 Human GH produced
in obacco chloroplast
J.M.Staub et al
2003 Expression and
assembly of a finctional
antibody in algae
S.P. Mayfield, S.E.
Franklin et al
2006 Commercial
production of bovine
trypsin in maize
S.L. Woodard et al

7. • By 2003 several PDP products for the treatment of human diseases were
under development by nearly 200 biotech companies,
including recombinant gastric lipase for the treatment of cystic fibrosis,
and antibodies for the prevention of dental caries and the treatment of non-
Hodgkin's lymphoma.
• I n 2006,Commercialized Plant made antibody and Plant-made vaccine were
developed.
• Research is still being pursued by competing groups using a range of
animals (large and small), outdoor plant production, indoor plant production,
and plant cell cultures. The proponents of each argue that their platform has
advantages in productivity, scalability, speed of response, safety of drug
produced, cost, or suitability to particular conditions. A significant amount
of this research is publicly funded.

8. INTRODUCTION TO PLANT BIOPHARMING
• Plant biopharming refers to the use of genetically modified plants
to produce a wide range of pharmaceuticals and industrial products.
• Biopharming includes both crops in which the pharmaceutical is
expressed, and the replication of seeds of such plants to enable
commercial production.
• This involves insertion of a gene, which encodes a protein of
interest, into an host organism. The host organism is grown to produce
large quantities of the protein, which is subsequently purified.
• Plants such as tobacco, for example, can be genetically engineered to produce therapeutic proteins,
monoclonal antibodies and vaccines to treat cancer, inflammatory diseases and other life-threatening or
debilitating conditions.
• Plants are also used in production of various enzymes, hormones, interferons, structural proteins etc.

9. GENERAL PROCEDURE OF PLANT
BIOPHARMING
• STEP 1:
• STEP 2:
• STEP 3:
• STEP 4:
• STEP 5:
ISOLATION OF GENE OF INTEREST
CONSTRUCTION OF TRANSGENE
TRANSFER OF FOREING GENE INTO
THE HOST
SELECTION OF TRANSGENIC PLANT
IDENTIFICATION AND ISOLATION OF
THE PLANT TISSUE

10. HOW IS PLANT BIOPHARMING DONE ?
• There are various ways to genetically modify plants to turn them into
mini factories or “bioreactors” for biologic drug and commercial production.
• NUCLEAR TRANSFORMATION: This transformation involves
the integration of foreign gene in the genome of a plant. Nuclear
transformation allows to target proteins to various subcellular regions
like endoplasmic reticulum, plastids, vacuole, apoplast, which facilitate
correct posttranslational modification.
• PLANT VIRAL SYSTEM: Expression of recombinant protein done
by a viral vector is a method for examining protein and its desired character
in a plant. Virus infected plants are used to get antigens and antibodies with
rapid onset of expression and more than one vector can be used in the same
plant. The plant produces the high quantity of desired protein within 1-4 weeks of inoculation.

11. • TRANSIENT EXPRESSION IN PLANTS:
• Fully grown plants, four to six weeks old, are immersed in the Agrobacterium suspension under
vacuum pressure, allowing the Agrobacterium to penetrate the plant cells to introduce the genes of
interest through a natural process, which alters the plant’s DNA and directs it to begin to manufacture
(express) the protein.
• After the plants are treated in this manner,
they grow for another week, generating biomass,
and are the harvested and the protein material
extracted and purified to make a biopharmaceutical
drug.

12. • STABLE TRANSGENIC PLANTS: Stable transgenic plants are developed by stably altering the
DNA of a plant’s nuclear or chloroplast genomes.
• Seed lines are then developed for continual propagation of plant biomass using traditional agricultural
techniques and equipment.
• In the leaves of higher plants, each cell has as many as 100 chloroplasts, each of which contains up to
100 copies of the genome.
• Thus, by inserting a transgene into the chloroplast
genome,one can greatly amplify the gene and produce
large amounts of the corresponding protein.

13. METHODS OF GENE TRANSFER IN PLANTS
• Two methods are used to transfer foreign genes into plants.
Use of a plant pathogen called Agrobacterium tumefaciens:
• Agrobacterium tumefaciens causes crown gall disease in many
species.
• This bacterium has a plasmid, that contains tumor-inducing
genes (T-DNA), along with additional genes that help the T-DNA
integrate into the host genome.
Agrobacterium must first be “disarmed” by removing most of the
T-DNA so that it does not make the plant sick leaving the left
and right border sequences, which integrate a foreign gene into
the genome of cultured plant cell.

14. • GENE GUN:
• Gene gun fires gold particles carrying the foreign DNA into plant cells.
• Some of these particles pass through the plant cell wall and enter the cell nucleus, where the
transgene integrates itself into the plant chromosome.
• Because both methods of gene transfer are fairly random, one must screen for the plant cells that
contain the foreign gene.

15. PLANT BIOPHARMING IN AGRICULTURE
The up- and down-regulation of desired genes which are used for the modification of plants have a
marked role in the improvement of genetic crops. The role of genetic engineering in generating
transgenic lines/cultivars of different crops is also to produce improved nutrient quality along with
resistance and better yield.
1.Transgenic rice: a) -carotene (Golden Rice), b) higher iron content, c) higher content of zinc etc.
2.Transgenic potato: a) gene from grain amaranth for high protein content
3. Transgenic maize: , a) higher content of lysine and tryptophan and b) nutritive value
equivalent to that of milk.
4. GE coffee: Decaffeinated by gene silencing

16. HOW TO MAKE GENETICALLY MODIFIED CROPS
• STEP 1:
• STEP 2:
• STEP 3:
• STEP 4:
• STEP 5:
TRANSFER OF DNA INTO A
PLANT CELL
GENE OF INTEREST IS TRANSFERRED
INTO THE BACTERIUM
TRANSFER THE NEW DNA TO THE
GENOME OF THE PLANT CELLS.
CHECKING FOR THE TRANSFORMANTS
GROWN TO CREATE A NEW PLANT

17. PLANTIBODIES: ANTIBODIES PRODUCED IN PLANTS
• The term “plantibodies” describes the products of plants
that have been genetically engineered to express antibodies
and antibody fragments.
• Plants are being used as antibody factories (bioreactors),
utilizing their endomembrane and secretory systems to
produce large amounts of clinically viable proteins which
can later be purified from the plant tissue.
• Antibodies, originally derived from animals, are produced
in plants by transforming the latter with animal antibody genes
• Plantibodies have been shown to function in the same way
as normal antibodies.

18. PRODUCING PLANTIBODIES
• STEP 1:
• STEP 2:
• STEP 3:
• STEP 4:
• STEP 5:
• STEP 6:
INTRODUCE NEW GENES
INTO A HOST
THE TRANSFORMANT CELL IS THEN
INTRODUCED INTO THE PLANT EMBRYO
PROPAGATION OF THE PLANT IN
THE OPEN FIELD
EXTRACTION OF THE ANTIBODIES FROM THE PLANT TISSUE
SELECTION OF
TRANSFORMANT CELL
PURIFICATION OF THE ANTIBODY

19. MONOCLONAL ANTIBODY PRODUCTION
Introduction of gene of
interest into the host
transformed plants
selected
cultivated in vitro
regeneration of mature
plants
propagation of plant cells as a
cell-suspension culture
Purification of antibodies expressed in
plants (affinity chromatography )
plant tissues
must be
homogenized
Contaminant
s and toxins
released
mAb purified

20. PLANT BIOPHARMING IN VACCINE
PRODUCTION
• Plant-based vaccines are recombinant subunit vaccine.
PLANT BASED
VACCINES
DISEASE
Hepatitis B surface
antigen (HBsAg)
(Tobacco Plant )
Hepatitis B
Heat labile toxin B
Subunit (LTB)
Potato Tuber
Diarrhoea
Rabies virus
glycoprotiein (RVG)
(Tomato leaf)
Rabies
Cholera toxin B
subunit
(Tobacco leafs )
Cholera
the antigen to be expressed as
capsid proteins are selected
proteins are expressed in plant tissues
Agrobacterium tumefeciens and the antigenic gene
to be inserted are mixed making a suspention
host plant explant is exposed to the
bacterial suspention
cells are cultured and grown
transformants
are looked for
and selected
Plant
regeneration
ready to be
used as vaccine.

22. ANIMAL
BIOPHARMING
 Animal biopharming is defined here as the farming of transgenic animals genetically modified to produce
“humanised” pharmaceutical substances for use in humans. Biopharming is also known as “molecular
farming”.
 Organisms that have altered genomes are known as transgenic. Most transgenic organisms are generated in
the laboratory for research purposes.
 Examples of types of animal biopharming currently being researched include cows, sheep and goats modified
to produce the substance in their milk and chickens modified to produce the substances in their eggs.
 Biopharming is one of several methods that can be used to produce the class of drugs known as
biopharmaceuticals.

24. STEPS INVOLVED IN BIOPHARMING
STEP – 1 ISOLATION OF GENE OF INTEREST
• A typical Gene of interest must ideally contain promoters, enhancers, introns, transcription terminator, coding
region.
• Techniques that are used to isolate the gene are PCR and RT-PCR.
STEP – 2 CONSTRUCTION OF TRANSGENE

25. STEPS INVOLVED IN BIOPHARMING
STEP-3 TRANSFER OF FOREIGN GENE INTO HOST
DNA transfer can be done six different methods :-
1. Direct microinjection
2. Transposons
3. Lentiviral Vector
4. Sperm
5. Pluripotent cells
6. Somatic Cells
STEP- 4 SELECTION OF TRANSGENIC ANIMAL
This can be achieved by : -
1. Probe hybridization
2. PCR and RT-PCR

26. STEPS INVOLVED IN BIOPHARMING
STEP – 5 IDENTIFICATION, ISOLATION, PURIFICATION OF RECOMBINANT PROTEINS
Identification – This can be achieved by :-
ELISA
Immunoelectrophoresis
Chromatography
Mass spectrometry
Isolation – The source material, whether blood serum, egg white, milk or any other tissue is manually isolated.
Purification – This process must be carried out for the removal of pathogens.

27. ANTITHROMBIN IN MILK

28. Alpha 1 PROTEINASE INHIBITOR IN SHEEP
• The human lungs are constantly get affected by foreign particles such as dust, spores and bacteria. To prevent these,
neutrophils releasing the elastase enzyme but this enzyme harmed the elastin in the lungs which maintains the elasticity of
lungs.
• Human body releases a protein α1 proteinase inhibitor which has been successfully expressed in sheep.
SPIDER GENES IN LACTATINGING GOATS -
• Two scientists at Nexia Biotechnologies in Canada spliced spider genes into the cells of lactating goats.
• The goats are used to manufacture silk, milk and secrete tiny strands from their body by the bucketful. By extracting
polymer strands from the milk and weaving them into thread which is light and tough material that could be used to
prepare military uniforms, medical micro sutures and tennis racket strings

29. SOME OTHER AREAS WHERE TRANSGENICS ANIMALS ARE USED :-
•Xenotransplantation
•Blood replacement
•Agriculture
•Disease control
•Toxicity testing
•Vaccine testing.

31. SOME FUNNY
COMBINATIONS
THAT WE CAN
THINK OF

32. REGULATORY ISSUES
• Different regulatory agencies may have different cultures and be embedded indifferent power relations, which can pose problems
for effective cooperation.
• Biopharming activity is generally being governed through regulatory frameworks developed forother purposes, and this can result
in regulatory gaps and poor fit.
• For example, agriculture and medicines are typicallysubject to different governance regimes, yet biopharm plants and animals
belong to both categories.
• Protecting the welfare of biopharm animals may also encounter category problems. For example,some jurisdictions distinguish
between experimental animal trials and the use of animals inproduction.
• Many of the welfare problems associated with biopharming result from experimentation on embryos rather than the animals
themselves, this possibly falls outside the regulation of animal trials.

33. • Regulation of drugs produced through biopharming was also adapted rather than purpose-built.
• Biopharming animals may also fall outside the protections extended to farm animals, because they do not serve
agricultural purposes.
• Good Manufacturing Practice (GMP) guidelines for biopharm drugs were originally modeled on those for animal
cell cultures. These, however, are seen as too restrictive by those working with whole plants.
• BT corn approved for animal consumption found in products for human consumption.

34. WHAT ARE THE PURPOSE OF BIOPHARMING ?
• Biopharming is the cultivation of crops for a pharmaceutical purpose, giving them the ability to produce
desired therapeutic proteins that are then extracted, purified, and used by the pharmaceutical industry to
produce large-molecule, protein-based drugs.
• Corn, rice, tobacco, and alfalfa are among the top candidates for being widely used in biopharming .
Benefits –
• Faster and easier production of large quantities of vaccine proteins .
• Significantly lower production costs than current practices.
• Safer vaccine antigen production.
• Production (in plants) of proteins of greater complexity than is possible with microorganisms and to
produce proteins that cannot be produced in mammalian cell cultures .

35. CONVENTIONAL TECHNIQUES
All of the recombinant proteins produced and marketed to date are
produced in bacterial, yeast, and mammalian cell culture systems.
 Most of the recombinant therapeutic proteins derived from transgenic
livestock are in clinical trial phases.
• Bacterial culture
• Yeast culture
• Insect cell culture
• Mammalian cell culture
• Transgenic Plants

37. CONVENTIONAL VS TRANSGENIC
CONVENTIONAL METHOD
• Higher cost .
• Limited post-translational
modification.
• Low yield of recombinant proteins.
• Scale up is difficult.
• Isolation complexity.
• Aseptic environment required.
TRANSGENIC METHOD
• Relatively lower cost.
• Almost all Post-Translational
modifications.
• Higher yield of recombinant proteins.
• Scale up is highly efficient.
• Relative ease in isolation.
• Requires normal care.

38. DIFFERENT BIOPHARMING PRODUCTION
SYSTEM
1. Stable nuclear transformation.
2. Plastids transformation.
3. Transient transformation.
4. Stable transformation.

39. 1 ) STABLE NUCLEAR
TRANSFORMATION
ADVANTAGES
• Long – term non – refrigerated storage the
seed upto 2yrs.
• Large acres can be utilized with the lowest
cost.
• E.g – Grains.
DISADVANTAGES
• Manual labor required.
• Lower yield.
• Less effective genetic.
• Outcrossing.
Most common.
A species with a long
generation cycle.
Foreign genes are transfer
via Agrobacterium
tumifaciens or particle
bombardment.
Genes are taken up &
incorporated In a stable
manner.

40. 2) PLASTID
TRANSFORMATION
ADVANTAGES
• No outcrossing .
• Protein - upto 70% on dry weight.
• Very high expression levels can be
achieved.
DISADVANTAGES
• Protein unstable.
• Extraction & purification at specific time.
• Edible vaccine is not feasible since tobacco is
highly regulated.
First described by Svab et al.
(1990).
Tobacco species only.
No transgenic pollen is
generated.

41. 3) TRANSIENT
TRANSFORMATION
ADVANTAGES
• Infection process is rapid .
• Small amounts target protein is obtained in
weeks.
• Efficient for custyom proteins needed in
small amount.
DISADVANTAGES
• Not needed for protein in large amount.
• No long term storage due to tissue
damage.
• Scalability & expression levels.
Depend on recombinant
plant viruses to infect tobacco
plants like TMV.
Target protein is temporary
express in the plant.
Protein accumulate in the
interstitial spaces.
No stable transgenic plants
are generated.

42. 4) STABLE
TRANSFORMATION
ADVANTAGES
• Plants are contained in green house.
• Reduced fears of environmental release.
• Easier purification.
DISADVANTAGES
• Expensive to operate .
• Not suitable for large scale production.
Transgenic plants are grown
hydroponically.
Hydroponics is a technology for
growing plants in nutrient
solutions (water & fertilizers ) for
high density maximum crop yield
, crop production where no
suitable soil exist.
Desired products are released as
part of root fluid into a
hydroponic medium.

43. ADVANTAGES OF BIOPHARMING -
• Biopharming is much safer than extracting protein from living or recently deceased organisms.
• lower costs and rapid scalability
• lower manufacturing facility costs
• fast turnaround/response times, high-yield production
• enhanced safety, with lower risk of contamination with animal and/or human pathogens
• the ability to produce novel and complex molecules
• Various plant species can be used for biopharmaceutical drug production, including tobacco, moss, algae,
alfalfa, rice and carrot.
• Biopharming offers several advantages over the other conventional methods of proteins production at higher
levels.
• The recombinant proteins are isolated from the various production systems of transgenic animals including
urine, blood, milk, egg, plasma etc.

44. DISADVANTAGES OF BIOPHARMING -
• Due to the high dispersal rate of plant seeds and pollen, biopharming crops containing
pharmaceuticals have the possibility of contaminating food crops.
• There may also be risks to insects and animals that pollinate or naturally consume the plants with
high chemical loads .
• Biopharming in animals also poses risks. First, many believe it is immoral to change an animal’s
genes for our benefit. It could be potentially harmful to the animal and have functions that can not
always be predetermined. There are also worried that genetically modified animals could escape
into the wild and impact the natural environment and wild species.
• Lastly, some critics believe that biopharming, or any other manipulation of genes, is unnatural and
unethical. Critics argue that many animals that could be used for biopharming, like pigs, are highly
intelligent social creatures and should not be used to produce pharmaceuticals. Others believe that
genetic modification could have detrimental effects that we can not yet understand or predict

45. INDUSTRIAL PRODUCTS IN MARKET
AVIDIN BY SIGMA
• transgenic corn
• traditionally isolated from chicken egg whites
• used in medical diagnostics(The use of avidin-biotin immunoassay enhances
the sensitivity of the technique and facilitates the detection of antigens in low
quantities.)
 GUS (B-GLYCURONIDASE) BY SIGMA
• transgenic corn
• traditionally isolated from bacterial sources (E.Coli)
• used as visual marker in research labs
 TRYPSIN BY SIGMA
• transgenic corn
• traditionally isolated from bovine pancreas
• variety of applications, including biopharmaceutical processing
• first large scale transgenic plant product
• Worldwide market = US$280 million in 2014 (Promo pharma

46. COMPANIES

48. RISKS
• Contamination of food chain: If a food crop is used, the biopharma crop may inter-breed through pollen drift
with the non-GM food crop and “contaminate” the food chain. This is a greater risk with outbreeding/ cross
pollinated crops like maize. Food crops could also become mixed or mingled with bio-pharm crops through
improper labelling, or mixing of seed in planting, harvesting, transportation, processing or through “volunteer”
plants (i.e. remnants of previous harvests) not being eliminated . Both these routes are a cause for concern due to
the potential harm to human health by contamination of food chain.
• Allergenicity: Plants process proteins differently from animals or humans - Thus, some experts are concerned
that a plant-produced “human” protein could be perceived as foreign by the body and elicit an allergic reaction,
including life-threatening anaphylactic shock.
• Impact upon non-target organisms: this is a known concern related to GM crops, but is a more significant risk
for biopharming since the introduced gene or its product may have negative effects on the natural environment.
For example, wildlife feeding on the crop may ingest harmful levels of the PBP, or soil micro-organisms may be
inhibited by decomposing crop residue or substances exuded from roots of PBP plants. • Exposure: Farm workers
may be exposed to unhealthy levels of a biopharmaceutical by absorbing products from leaves through their skin,
inhaling pollen, or breathing in dust at harvest.
• Inconsistent dosage: Variations between the levels of proteins and other products expressed mean that the
dosage has to be quality controlled and administration supervised.
• Unexpected effects on drug: Unexpected toxins or residues of pesticides used on the crop may contaminate the
final drug product .
• The production of pharmaceuticals in the milk of transgenic farm animals has raised some biosafety concerns
because the expression of a transgene can be unpredictable, there is the risk that the protein product could “leak”
from the mammary gland and enter the animal’s blood circulation to cause harmful systemic effects.
• Meat contaminated with potentially harmful pharmaceuticals might enter the human food supply.
• Transgenic farm animals may also have harmful environmental effects if they escape or are released from
captivity and mate with wild individuals of the same species.
Two incidents involving the same company,
ProdiGene, in the US have shown these concerns
to be a reality. In 2001, ProdiGene failed to
eliminate volunteer biopharm plants from a
soybean crop planted later in the same field (Fox,
2003). The company was fined by the US
Department of Agriculture (USDA) and was
required to reimburse the government for
expenses related to the destruction of the
potentially contaminated soybean harvest (Byrne,
2008). ProdiGene was involved in a similar event
in 2004 where volunteer transgenic maize
contaminated an oat crop which was harvested
and baled for use as onfarm animal feed, and was
also found growing and flowering in a nearby
sorghum field (Rybicki, 2009c). As a result of
these two incidents, there is an effective
moratorium on vaccine pharming in edible crops
worldwide.

49. SOLUTIONS TO RISKS
1. The risk of cross-pollination is dealt with by isolation zones, managed cooperatively at industry level by
searching for, and destroying rogues, i.e. plants that have escaped into the wild.
2. Volunteers are dealt with by crop rotations, spray regimes, tillage techniques, and by rogueing, or manually
weeding crops.
3. Machinery is cleaned thoroughly to avoid the mixing of seed, and cleaning is monitored by production
companies to make sure protocols are being followed. Furthermore, for very high value seed production
companies use specially designated machinery.
4. Post-harvest there are sophisticated traceability and testing procedures to reduce the possibility of
contamination.
5. These practices and procedures are highly effective and allow growers and production companies to
consistently produce uncontaminated crops.
6. It is this experience of success that underlies grower and production company willingness to consider
growing bio-pharm crops and their confidence in their ability to grow such crops with as great a degree of safety
as is possible

50. ETHICAL ISSUES
 Concerns about escape of transgene.
 Should patents be allowed on
transgenic animals?
 Limits data and animal sharing.
 Risk of escape of transgene viral
vector.
 Welfare of other life forms.
 Ecological concerns.
The use of farm animals for the production of human
pharmaceuticals raises difficult animal welfare issues. Does the
benefit of biopharming to humans justify the use of animals for
this purpose?
Forexample,animal-welfareadvocates,suchastheBritishgroupUncaged,have
raisedstrongethicalobjectionstotheuseofpigsforxenotransplantation.They
notethatpigsarehighlyintelligentandsocialanimals,andthateffortstoeliminate
PERVswouldrequireraisingtheminisolated,sterileenvironmentsthatwould
causetheanimalsemotionalandpsychologicalsufferingandwouldresultin
abnormalbehavioraldevelopment.

51. WHY PLANTS OVER ANIMAL
BIOPHARMING?

52. REASEARCH AND PROJECTS• Genetically engineered Arabidopsis plants can sequester arsenic from
the soil. (Dhankher et al. 2002 Nature Biotechnology)
• Immunogenicity in human of an edible vaccine for hepatitis B (Thanavala
et al., 2005. PNAS)
• Expression of single-chain antibodies in transgenic plants. (Galeffi et al.,
2005 Vaccine)
• Plant based HIV-1 vaccine candidate: Tat protein produced in spinach.
(Karasev et al. 2005 Vaccine)
• Plant-derived vaccines against diarrheal diseases.
(Tacket. 2005 Vaccine)
• The current situation in the biopharming industry is difficult
to assess. It is a developing industry with a large number of
companies entering and exiting.
• Biopharming is one area of a larger industry focused on
producing biological compounds of pharmaceutical interest.
In biopharming, these compounds are produced using crop
plants or livestock.
The two largest research groups focusing on the production of human and animal
vaccines and therapeutic proteins using plants are situated at the Council for Scientific
and Industrial Research (CSIR) and the University of Cape Town (UCT). For example,
the CSIR has produced RabiVir – a plant-made antibody cocktail for rabies prophylaxis
– and plant-made subunit animal vaccines. The UCT has shown the first proof of
efficacy of a plant-produced papillomavirus vaccine for humans and is also involved in
various plant-made subunit animal vaccines. Further, AzarGen Biotechnologies is a
South African SME involved in therapeutic protein production in plants, with their
leading candidate recombinant product being a human surfactant protein that increases
the survivability of premature infants. AzarGen has partnered with iBio, a US
commercial bio-manufacturer for plant-expressed protein production. However, if the
South African biopharming industry continues with the momentum that it currently has,
local biopharming manufacturing facilities are also likely to be established.

53. FUTURE PROSPECTS
Science has developed genetically enhanced crops
and has/can develop plant-made industrial and
pharmaceuticals crops.
The extent to which these crops will be further
developed for commercial and/or humanitarian use
will ultimately depend on…..
Scientists already proved the successful multiplication of many
pharmaceutical compounds and vaccines apart from beneficial
proteins antibodies etc. within plant system successfully with
low cost. The biggest ever challenge solved was multiplication of
Ebola virus drug ZMapp (Kentucky Bioprocessing LLC) in
transgenic tobacco plants. Now India patented the drug to cure
Zica virus (February 2016, Bharat Biotech company, Hyderabad).
So it is a big challenge for India to multiply it within a short time
to prevent the virus quickly spreading in the western countries,
which can be achieved through biopharming. The only task
before us is the non-acceptance of transgenics by government as
well as the society. Hope if biopharming is accepted there will be
tremendous improvement in target substance multiplication in a
better and safer way.
Public
perception
of risk
Regulation

54. SUMMARY
At present, environmental degradation and the consistently growing population are two main problems on the
planet earth. Fulfilling the needs of this growing population is quite difficult from the limited arable land available
on the globe. Although there are legal, social and political barriers to the utilization of biotechnology, advances in
this field have substantially improved agriculture and human life to a great extent.
Biopharming involves genetically engineering plants and animals, typically with human gene constructs, to
produce biopharmaceuticals. It has thus far received little attention within bioethics or among social scientists. The
nature and scope of the potential opportunities represented by biopharming remain unclear. The potential hazards
associated with biopharming are wide-ranging and vary according to the “platform” used. Regulation of
biopharming has not kept up with technological development and is arguably under-specified. Biopharming raises
ethical issues in relation to the performative effects of inflated benefit claims, the infliction of harm and potential
harm on bio-pharm animals and other organisms (including humans), the opportunity to consider alternatives and
the significance and distribution of cost savings when evaluating biopharming’s acceptability, the values
embedded in regulatory frameworks, and the proper response to uncertainty regarding far-reaching effects.

55. THANK YOU