Agriculture Reference
In-Depth Information
recombinant. pharmaceutical. proteins.. At. present. stage,. plants. provide. a. serious.
viable..alternative.to.the.traditional.mammalian.or.microbial.cell.culture.technolo-
gies,.allowing.for.cost-effective,.highly.scalable,.and.safe.production.of.pharma-
ceutical.proteins.
PLANTS PROVIDE A NEW MANUFACTURING
TECHNOLOGY FOR PHARMACEUTICAL PROTEINS
The.majority.of.pharmaceutical.proteins.are.currently.produced.in.mammalian.cell.
cultures,.with.a.few.exceptions.produced.in.
Escherichia coli
,.yeast,.or.insect.cells.
8
.
As. one. of. the. fundamental.technological.revolutions. in.the. pharmaceutical.indus-
try,.the.development.and.optimization.of.mammalian.cell.culture.allow.for.uniform.
production.of.pharmaceutical.proteins.with.high.eficacy..However,.mammalian.and.
other. cell. culture-based. production. systems. rely. on. the. fermentation. of. cells. sus-
pended.in.bioreactors,.which.requires.a.large.initial.capital.investment.and,.there-
fore,. severely. constrains. their. economic. effectiveness. and. scalability.. Application.
of.such.technologies.in.the.developing.world.will.not.only.face.intellectual.property.
challenges,.but.undoubtedly.will.also.encounter.further.inancial.and.logistical.bar-
riers.that.are.dificult.to.overcome..Meanwhile,.the.worldwide.demand.for.protein-
based.pharmaceuticals.has.greatly.increased.for.the.last.two.decades..If.the.demand.
for.such.products.cannot.be.met.or.if.they.are.too.costly.to.produce.for.health.care.
systems,. all. of. the. advances. in. recombinant. pharmaceutical. protein. creation. and.
optimization,.as.well.as.the.vast.therapeutic.potential.of.these.agents,.are.made.irrel-
evant..This.urgent.situation.calls.for.the.development.of.new.production.platforms.
that.are.cost-effective,.scalable,.and.safe.
Plant-based.protein.production.technology.combines.the.innovations.in.medicine.
and. plant. biology. and. has. a. great. potential. to. produce. affordable. pharmaceutical.
proteins. at. a. large. scale.. Plants. can. produce. large. volumes. of. proteins. eficiently.
and.sustainably,.and,.under.certain.conditions,.with.signiicantly.lower.manufactur-
ing.costs.than. mammalian. cell.cultures.
9-13
. Plants. are.also.far. less. likely. to. intro-
duce.human.or.animal.pathogens.to.humans.compared.to.mammalian.cells.or.whole.
transgenic. animal. systems.. Unlike. bacterial. and. other. prokaryotic. systems,. plants.
share. a. similar. endomembrane. system. and. secretory. pathway. with. human. cells.
14
.
Therefore,.plant.cells.are.able.to.eficiently.assemble.multiple.subunit.proteins.and.
perform. necessary. posttranslational. modiications. on. transgenic. pharmaceutical.
proteins..The.low-cost,.high-scalability,.and.safety.characteristics.of.plant.produc-
tion.system.offer.an.attractive.alternative.technology.platform.for.both.commercial.
pharmaceutical.production.and.for.manufacturing.products.for.the.developing.world..
In.fact,.an.increasing.number.of.academic.and.industrial.laboratories.are.investing.in.
plant-made.protein.pharmaceuticals.(PMPs)..While.much.research.is.still.required.
to.optimize.plant.production.of.pharmaceuticals.and.to.validate.them.in.large-scale.
clinical. trials,. the. results. to. date. show. a. promising. technology. that. justiies. com-
mercial.development.
Currently,.three.strategies.are.primarily.employed.for.the.expression.of.pharma-
ceutical.proteins.in.plants.including.the.stable.transformation.of.the.nuclear.genome,.
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