Green Analytical Chemistry,
Год журнала:
2024,
Номер
10, С. 100122 - 100122
Опубликована: Июнь 25, 2024
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ABSTRACT
The
ICH
Q14
guideline
introduces
a
structured
framework
for
analytical
method
development
based
on
Analytical
Quality
by
Design
(AQbD)
principles,
aiming
to
ensure
robust,
reliable,
and
fit‐for‐purpose
methods
throughout
the
product
lifecycle.
However,
implementing
remains
challenging
due
lack
of
complete
examples
training
resources,
making
it
difficult
organizations
translate
theory
into
practice.
Although
previous
studies
have
applied
AQbD
capillary
electrophoresis
development,
many
focused
only
specific
aspects
such
as
design
experiments
(DoEs)
or
target
profile
(ATP),
leaving
gap
in
providing
comprehensive,
practical
tools
entire
This
manuscript
presents
novel,
user‐friendly
approach
AQbD,
offering
ready‐to‐implement
methodologies
that
simplify
process
design,
optimization,
validation,
implementation.
Through
stepwise
process,
provides
solutions
integrating
principles
everyday
workflows,
bridging
between
theoretical
concepts
real‐world
applications.
has
been
thoroughly
tested
diverse
industrial
settings,
demonstrating
its
reliability
effectiveness.
work
aims
facilitate
adoption
tools,
lessons
learned,
best
practices
align
with
guidelines.
Therapeutic
mAbs
show
a
specific
"charge
fingerprint"
that
may
affect
safety
and
efficacy,
and,
as
such,
it
is
often
identified
critical
quality
attribute
(CQA).
Capillary
iso-electric
focusing
(cIEF),
commonly
used
for
the
evaluation
of
such
CQA,
provides
an
analytical
tool
to
investigate
mAb
purity
identity
across
product
lifecycle.
Here,
we
discuss
results
analysis
panel
antibody
products
by
conventional
whole-column
imaging
cIEF
systems
performed
part
European
Pharmacopoeia
activities
related
development
"horizontal
standards"
control
monoclonal
antibodies
(mAbs).
The
study
aimed
at
designing
verifying
independent
transversal
procedure
reliable
charge
variants.
Despite
use
comparable
experimental
conditions,
discrepancies
in
profile
measured
isoelectric
points
emerged
between
two
systems.
These
data
suggest
are
method-dependent
rather
than
absolute,
aspect
known
experts
field
pharmaceutical
industry,
but
not
suitably
documented
literature.
Critical
implications
from
regulatory
perspectives,
herein
thoughtfully
discussed,
with
special
focus
on
context
market
surveillance
identification
falsified
medicines.
Journal of Pharmaceutical Analysis,
Год журнала:
2024,
Номер
14(12), С. 101004 - 101004
Опубликована: Май 23, 2024
Extracellular
vesicles
(EVs)
are
a
part
of
cell-to-cell
communication
system
prokaryotic
and
eukaryotic
organisms.
Their
ability
to
penetrate
biological
barriers
transfer
molecules
between
cells
shows
their
potential
as
novel
class
drug
delivery
platform.
However,
because
the
great
heterogeneity
EVs
complexity
matrices
from
which
they
typically
isolated,
reliable
quality
control
procedures
need
be
established
ensure
safety
for
medical
use.
According
current
recommendations,
quantification
EVs,
confirmation
identity,
purity
assessment
require
use
several
analytical
techniques,
including
particle-size
distribution
analysis,
proteomics,
electron
microscopy,
making
characterization
process
demanding.
Capillary
electrophoresis
(CE)
has
recently
emerged
an
alternative
tool
EV
characterization.
In
this
study,
available
literature
on
concept
was
reviewed.
Its
performance
critically
evaluated
compared
with
currently
used
methods.
The
utility
CE
in
EV-based
medicines
discussed.
Biosensors,
Год журнала:
2024,
Номер
14(3), С. 119 - 119
Опубликована: Фев. 22, 2024
Analyte
migration
order
is
a
major
aspect
in
all
migration-based
analytical
separations
methods.
Presented
here
the
manipulation
of
microparticles
an
insulator-based
electrokinetic
separation.
Three
distinct
particle
mixtures
were
studied:
binary
mixture
particles
with
similar
electrical
charge
and
different
sizes,
two
tertiary
sizes.
Each
one
was
separated
twice,
first
separation
performed
under
low
voltage
(linear
regime)
second
high
(nonlinear
regime).
Linear
electrophoresis,
which
discriminates
by
charge,
dominant
effect
linear
regime;
while
nonlinear
size
shape,
regime.
The
results
obtained
three
illustrated
that
elution
can
be
changed
switching
from
regime
to
Also,
cases,
better
performances
terms
resolution
(Rs)
employing
allowing
electrophoresis
discriminatory
mechanism.
These
findings
could
applied
analyze
complex
samples
containing
bioparticles
interest
within
micron
range.
This
report
where
altered
iEK
system.
Journal of Pharmaceutical and Biomedical Analysis,
Год журнала:
2024,
Номер
249, С. 116352 - 116352
Опубликована: Июль 14, 2024
Messenger
RNA
(mRNA)
is
rapidly
growing
as
a
therapeutic
modality
for
vaccination
and
the
treatment
of
wide
range
diseases.
As
result,
there
an
increased
demand
mRNA-based
analytical
methods
capable
assessing
purity
stability,
which
are
considered
critical
quality
attributes
(CQAs).
In
recent
decades
capillary
electrophoresis
(CE)
has
emerged
alongside
liquid
chromatography
(LC)
important
tool
assessment
stability
mRNA
therapeutics.
CE
offers
variety
advantages
over
conventional
LC
or
gel-based
methods,
including
reduced
injection
volume,
resolution,
separation
efficiency.
this
study
we
compared
CE-based
methods:
Agilent
6000
Nano
Kit,
Revvity
Reagent
Sciex
9000
Purity
Integrity
HS
Kit.
These
were
evaluated
on
their
vendor-recommended
instruments:
Bioanalyzer,
LabChip
GXII,
PA800
Plus,
Fragment
Analyzer,
respectively.
We
assessed
ability
these
to
measure
integrity,
purity,
stability.
Furthermore,
several
parameters
each
method
also
assessed:
selectivity,
precision,
analysis
time,
ease
use.
Based
our
results,
all
four
suitable
use
in
characterization
vitro
transcribed
(IVT)
mRNA,
depending
intended
application.
The
kit
achieved
highest
selectivity
resolving
power
with
other
making
it
most
high-resolution,
in-depth
sample
characterization.
comparison,
Kit
lower
but
faster
times
make
them
more
high-throughput
screening
applications.
