Agriculture Reference
In-Depth Information
transcription.and.translation.remain.being.switched.off.during.plant.growth.until.
upon.the.application.of.the.speciic.inducer.molecules.or.stimulus..Therefore,.no.
transgenic.products.are.produced.in.the.ield,.and.they.are.only.made.after.being.
harvested.and.transported.into.a.controlled.environment..Such.inducible.systems.
have.been.applied.to.both.nuclear.and.chloroplast.transgenic.plants.
229,231
.It.is.impor-
tant.to.note.that.none.of.the.above.biological.containment.is.absolute.or.is.working.
in. all. circumstances.. Novel. containment. strategies. with. high. level. of. reliability.
and.simplicity.are.still.highly.desired.for.PMP.plants.
r
eGulatory
p
olIcIeS
reGardInG
pmp
In.the.United.States,.the.regulatory.responsibilities.of.PMPs.are.distributed.among.
three. relevant. agencies:.the. US. Department.of. Agriculture.(USDA),.the. Food. and.
Drug.Administration.(FDA),.and.the.Environmental.Protection.Agency.(EPA).
The. regulatory. environment. has. evolved. tremendously. since. the. infancy. of. the.
PMP.development.
227,262
.At.the.beginning,.the.novelty.and.complexity.of.this.tech-
nology.caused.confusions.on.which.regulatory.agencies.should.regulate.it.or.where.
the.PMP.would.it.into.the.regulatory.agencies'.structured.framework.for.biotech-
nology.pharmaceuticals..This.uncertain.regulatory.environment.contributed.to.the.
inertia.of.large.pharmaceutical.companies.toward.PMPs.and.other.new.production.
systems..With.the.great.stride.of.PMP.ield.in.the.last.few.years,.however,.the.regula-
tory.environment.has.also.evolved.from.a.chaotic.situation.in.which.the.regulatory.
bodies.could.not.coordinate.with.each.other.to.a.more.welcoming.climate.where.the.
regulatory. agencies. have. a. more. deined. role. in. regulating. PMPs. and. coordinate.
with.each.other.and.begin.to.work.with.scientists.to.establish.more.clear.policies.and.
guidelines.speciically.for.PMPs.
262,264
CONCLUSION
Enormous.strides.have.been.made.in.the.past.decade.with.respect.to.PMP.expression.
and. optimization.. A. wide. spectrum. of. pharmaceutical. proteins. has. been. success-
fully.produced.with.active.functionality.in.a.variety.of.crop.and.noncrop.plant.sys-
tems..Plant.expression.strategies.based.on.the.combination.of.viral.vector.transient.
expression.and.stable.transgenic.plants.have.the.greatest.potential.to.provide.a.tech-
nology.with.the.speed.and.scalability.required.for.producing.affordable.high-quality.
pharmaceutical.proteins.to.meet.the.increasing.global.demand..New.technologies.for.
downstream.processing.have.received.increasing.attention.and.are.being.developed.
to.realize.the.full.potential.of.the.PMP.platform..However,.like.any.biotechnology.
innovation,. the. ultimate. commercial. success. of. this. technology. cannot. solely. rely.
on. its. scientiic. and. technical. merits.. Before. reaching. its. full. commercial. poten-
tial,. extensive. work. has. to. be. done. to. overcome. challenges. in. areas. of. its. social.
acceptance.and.in.attracting.the.interest.of.capital.investment.and.big.pharmaceuti-
cal.companies..Ultimately.with.technical.optimization.and.careful.implementation.
under.regulatory.guidelines,.plant.expression.technology.will.support.the.production.
of.pharmaceutical.proteins.with.scalability,.speed,.eficiency,.cost-effectiveness,.and.
safety.at.a.commercial.scale.
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