Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives
Acta Biomaterialia,
Год журнала:
2024,
Номер
180, С. 1 - 17
Опубликована: Апрель 10, 2024
This
analysis
explores
the
principal
regulatory
concerns
linked
to
nanomedicines
and
gene
vaccines,
including
complexities
involved
perspectives
on
how
navigate
them.
In
realm
of
nanomedicines,
ensuring
safety
nanomaterials
is
paramount
due
their
unique
characteristics
potential
interactions
with
biological
systems.
Regulatory
bodies
are
actively
formulating
guidelines
standards
assess
risks
associated
nanomedicine
products,
emphasizing
need
for
standardized
characterization
techniques
accurately
gauge
effectiveness.
Regarding
frameworks
must
be
tailored
address
distinct
challenges
posed
by
genetic
interventions,
necessitating
special
considerations
in
efficacy
evaluations,
particularly
concerning
vector
design,
target
specificity,
long-term
patient
monitoring.
Ethical
such
as
autonomy,
informed
consent,
privacy
also
demand
careful
attention,
alongside
intricate
matter
intellectual
property
rights,
which
balanced
against
imperative
widespread
access
these
life-saving
treatments.
Collaborative
efforts
among
bodies,
researchers,
patent
offices,
private
sector
essential
tackle
effectively,
international
cooperation
being
especially
crucial
given
global
scope
vaccine
development.
Striking
right
balance
between
safeguarding
properties
promoting
public
health
vital
fostering
innovation
equitable
ground-breaking
technologies,
underscoring
significance
addressing
hurdles
fully
harness
benefits
vaccines
enhancing
healthcare
outcomes
a
scale.
STATEMENT
OF
SIGNIFICANCE:
Several
biomaterials
proposed
development
nanovaccines,
from
polymeric
micelles,
PLGA-/PEI-/PLL-nanoparticles,
solid
lipid
nananoparticles,
cationic
lipoplexes,
liposomes,
hybrid
materials,
dendrimers,
carbon
nanotubes,
hydrogels,
quantum
dots.
Lipid
nanoparticles
(LNPs)
have
gained
tremendous
attention
since
US
Food
Drug
Administration
(FDA)
approval
Pfizer
Moderna's
COVID-19
raising
awareness
vaccines.
review
provides
insights
into
current
strategies
issues,
clinical
trials.
By
navigating
landscapes
we
can
unlock
full
using
range
promising
towards
improving
worldwide.
Язык: Английский
Tumor microenvironment responsive multifunctional smart living materials based on engineered bacteria for inducing macrophage polarization to enhance tumor immunotherapy
Chemical Engineering Journal,
Год журнала:
2024,
Номер
488, С. 150820 - 150820
Опубликована: Март 29, 2024
Язык: Английский
Emerging Cationic Nanovaccines
Pharmaceutics,
Год журнала:
2024,
Номер
16(11), С. 1362 - 1362
Опубликована: Окт. 25, 2024
Cationic
vaccines
of
nanometric
sizes
can
directly
perform
the
delivery
antigen(s)
and
immunomodulator(s)
to
dendritic
cells
in
lymph
nodes.
The
positively
charged
nanovaccines
are
taken
up
by
antigen-presenting
(APCs)
lymphatic
system
often
originating
cellular
immunological
defense
required
fight
intracellular
microbial
infections
proliferation
cancers.
molecules
imparting
positive
charges
exhibit
a
dose-dependent
toxicity
which
needs
be
systematically
addressed.
Against
coronavirus,
mRNA
cationic
evolved
rapidly.
Nowadays
have
been
formulated
against
several
with
advantage
compounds
granting
protection
nucleic
acids
vivo
biodegradation
nucleases.
Up
threshold
concentration
for
nanovaccine
delivery,
well
eliciting
desired
Th
1
improved
immune
response
absence
cytotoxicity.
A
second
strategy
literature
involves
dilution
components
biocompatible
polymeric
matrixes.
Polymeric
nanoparticles
incorporating
at
reduced
concentrations
component
result
an
toxic
effects.
progress
vaccinology
cancer
situ
designs
nanovaccines.
lysis
transformed
releases
tumoral
antigens,
presence
nanoadjuvants
systemically
presented
prevention
metastatic
cancer.
In
addition,
these
local
allow
immunotherapeutic
tumor
treatment.
Язык: Английский