Separation Science Plus,
Год журнала:
2023,
Номер
6(9)
Опубликована: Авг. 15, 2023
Abstract
Impurities
found
in
active
pharmaceutical
ingredients
(APIs)
and
products
are
of
ever‐increasing
interest.
According
to
several
regulatory
agencies,
purity
impurity
profiles
essential.
An
is
defined
as
any
additional
inorganic
or
organic
material,
residual
solvents
other
than
the
medicinal
components,
undesired
compounds
that
remain
with
APIs.
degradation
bulk
drug
materials
formulations
identified,
their
structures
clarified,
quantitative
determination
part
profiling.
Unrecognized,
poisonous
impurities
dangerous
health
should
be
identified
by
selective
procedures
increase
safety
therapy,
profiling
has
become
more
significant
analysis.
This
review
briefly
introduces
process
product‐related
emphasizes
creation
cutting‐edge
analytical
techniques
for
identifying
them.
It
discusses
use
methods,
particularly
high‐performance
thin‐layer
chromatography,
liquid
chromatography
mass
spectrometry
(MS),
ultrahigh‐performance
gas
chromatography–MS,
nuclear
magnetic
resonance
spectroscopy
identification
contaminants
products.
discussed
importance
quality,
efficacy,
substances
products,
including
origin,
types,
quality
control
impurities,
need
development
identification,
aspects.
Pharmaceutics,
Год журнала:
2022,
Номер
14(11), С. 2533 - 2533
Опубликована: Ноя. 20, 2022
Maintaining
the
structure
of
protein
and
peptide
drugs
has
become
one
most
important
goals
scientists
in
recent
decades.
Cold
thermal
denaturation
conditions,
lyophilization
freeze
drying,
different
pH
concentrations,
ionic
strength,
environmental
agitation,
interaction
between
surface
liquid
air
as
well
solid,
even
architectural
storage
containers
are
among
factors
that
affect
stability
these
therapeutic
biomacromolecules.
The
use
genetic
engineering,
side-directed
mutagenesis,
fusion
strategies,
solvent
addition
various
preservatives,
surfactants,
additives
some
solutions
to
overcome
problems.
This
article
will
discuss
types
stress
lead
instabilities
proteins
used
pharmaceutics
including
regulatory
proteins,
antibodies,
antibody-drug
conjugates,
then
all
methods
for
fighting
stresses
be
reviewed.
New
existing
analytical
detect
instabilities,
mainly
changes
their
primary
higher
order
structures,
briefly
summarized.
Electrophoresis,
Год журнала:
2023,
Номер
44(17-18), С. 1279 - 1341
Опубликована: Авг. 3, 2023
Abstract
This
review
is
in
support
of
the
development
selective,
precise,
fast,
and
validated
capillary
electrophoresis
(CE)
methods.
It
follows
up
a
similar
article
from
1998,
Wätzig
H,
Degenhardt
M,
Kunkel
A.
“Strategies
for
electrophoresis:
method
validation
pharmaceutical
biological
applications,”
pointing
out
which
fundamentals
are
still
valid
at
same
time
showing
enormous
achievements
last
25
years.
The
structures
both
reviews
widely
similar,
order
to
facilitate
their
simultaneous
use.
Focusing
on
applications,
successful
use
CE
now
demonstrated
by
more
than
600
carefully
selected
references.
Many
those
recent
reviews;
therefore,
significant
overview
about
field
provided.
There
extra
sections
sample
pretreatment
related
microchip
CE,
completely
revised
section
protein
analytes
biomolecules
general.
general
strategies
summed
with
regard
selectivity,
efficiency,
precision,
analysis
time,
limit
detection,
requirements,
validation.
Journal of Separation Science,
Год журнала:
2023,
Номер
46(15)
Опубликована: Май 26, 2023
Capillary
electrophoresis
is
recognized
as
a
valued
separation
technique
for
its
high
efficiency,
low
sample
consumption,
good
economic
and
ecological
aspects,
reproducibility,
complementarity
to
traditional
liquid
chromatography
techniques.
experiments
are
generally
performed
utilizing
optical
detection,
such
ultraviolet
or
fluorescence
detectors.
However,
in
order
provide
structural
information,
capillary
hyphenated
highly
sensitive
selective
mass
spectrometry
has
been
developed
overcome
the
limitations
of
detections.
electrophoresis‐mass
increasingly
popular
protein
analysis,
including
biopharmaceutical
biomedical
research.
It
frequently
applied
determination
physicochemical
biochemical
parameters
proteins,
offers
excellent
performance
in‐depth
characterizations
biopharmaceuticals
at
various
levels
also
already
proven
promising
tool
biomarker
discovery.
In
this
review,
we
focus
on
possibilities
analysis
their
intact
level.
Various
modes
interfaces,
well
approaches
prevent
adsorption
enhance
loading
capacity,
discussed
recent
(2018–March
2023)
developments
applications
field
summarized.
Analytical Chemistry,
Год журнала:
2021,
Номер
94(2), С. 892 - 900
Опубликована: Дек. 23, 2021
Qualitative
and
quantitative
mass
analysis
of
antibodies
related
macromolecular
immune
complexes
is
a
prerequisite
for
determining
their
identity,
binding
partners,
stoichiometries,
affinities.
A
plethora
bioanalytical
technologies
exist
to
determine
such
characteristics,
typically
based
on
size,
interaction
with
functionalized
surfaces,
light
scattering,
or
direct
measurements.
While
these
methods
are
highly
complementary,
they
also
exhibit
unique
strengths
weaknesses.
Here,
we
benchmark
photometry
(MP),
recently
introduced
technology
measurement,
against
native
spectrometry
(MS)
size
exclusion
chromatography
multi-angle
scattering
(SEC-MALS).
We
examine
samples
variable
complexity,
namely,
IgG4Δhinge
dimerizing
half-bodies,
IgG-RGY
hexamers,
heterogeneously
glycosylated
IgG:sEGFR
antibody–antigen
complexes,
finally
megadalton
assemblies
involved
in
complement
activation.
thereby
assess
the
ability
(1)
affinities
(2)
accurate
masses,
extensively
species,
(3)
assembly
pathways
large
heterogeneous
complexes.
find
that
MP
provides
sensitive
approach
characterizing
stable
assemblies,
dissociation
correction
enabling
us
expand
measurable
affinity
range.
In
terms
resolution
accuracy,
MS
performs
best
but
occasionally
hampered
by
artifacts
induced
electrospray
ionization,
its
resolving
power
diminishes
when
analyzing
proteins.
latter
cases,
well,
single-particle
charge
detection
can
be
useful
this
respect,
measuring
masses
even
more
accurately.
Both
perform
well
compared
SEC-MALS,
still
being
most
established
method
biopharma.
Together,
our
data
highlight
complementarity
approaches,
each
having
ACS Applied Nano Materials,
Год журнала:
2023,
Номер
6(13), С. 11990 - 12001
Опубликована: Июль 4, 2023
Emerging
metal–organic
framework
(MOF)-based
nanomaterials
such
as
nanozymes
have
attracted
interest
and
been
applied
in
the
detection
of
biomolecules
like
glutathione
(GSH).
It
is
still
difficult
to
distinguish
GSH
from
cysteine
(Cys)
ascorbic
acid
(AA)
because
most
antioxidants
behave
similarly.
However,
appropriate
catalytic
activity,
high
surface
area,
etc.,
MOF-based
can
allow
entry
into
molecular
substrates,
analytes,
complete
contact
with
active
sites.
Then,
this
study,
colorimetric
fluorometric
based
on
oxidase
mimetic
activity
was
investigated
using
mixed-valence
state
V2O5-(Ce3+/Ce4+)-MOF
nanozyme.
This
sensor
demonstrated
a
suitable
linear
analytical
response
area
0.1–75
0.1–40
μM
limit
0.048
0.06
for
methods,
respectively.
determined
that
vanadium
should
direct
molecules
trigger
its
activation
effect
glutathione-peroxidase.
In
addition,
it
could
help
preconcentration
catalyst's
surface.
When
states
(Ce3+/Ce4+)-MOF
covered
by
generated
GSSG
are
catalyst
Therefore,
strongly
inhibits
oxidation
tetramethylbenzidine
(TMB)
oxidase-like
catalyst.
TMB
study's
strategy
glutathione-peroxidase-like
design
sensors
will
provide
unique
pathway
improving
efficiency
MOF-nanozyme-based
sensors.
Analytical Chemistry,
Год журнала:
2023,
Номер
95(8), С. 4059 - 4066
Опубликована: Фев. 17, 2023
Characterization
of
charge
heterogeneity
is
an
essential
pillar
for
pharmaceutical
development
and
quality
control
therapeutic
monoclonal
antibodies
(mAbs).
The
highly
selective
commonly
applied
capillary
zone
electrophoresis
(CZE)
method
containing
high
amounts
ε-aminocaproic
acid
(EACA)
provides
a
detailed
robust
profile
intact
mAb
variants.
Nevertheless,
the
exact
location
protein
modifications
within
these
profiles
remains
ambiguous.
Electrospray
ionization
mass
spectrometry
(ESI-MS)
promising
tool
this
purpose;
however,
EACA
incompatible
with
electrospray.
In
context,
we
present
two-dimensional
CZE-CZE-MS
system
to
combine
efficient
variant
separation
mAbs
subsequent
peptide
analysis
after
in-capillary
digestion
selected
first
dimension
based
on
generic
CZE(EACA)
in
fused
silica
capillary.
second
dimension,
neutral-coated
used
reduction
Tris(2-carboxyethyl)phosphine
(TCEP)
pepsin,
followed
by
CZE
MS/MS-characterization
resulting
peptides.
setup
demonstrated
using
stressed
nonstressed
where
peaks
basic,
main,
acidic
variants
were
transferred
heart-cut
fashion,
digested,
characterized
level.
Sequence
coverages
more
than
90%
obtained
heavy
chain
(HC)
light
(LC)
four
different
mAbs,
including
low-abundance
(<2%
main
peak).
Frequently
observed
(deamidation,
oxidation,
etc.)
could
be
detected
localized.
This
study
demonstrates
proof-of-concept
identification
localization
from
and,
way,
expected
support
testing
pharmaceuticals.
Journal of Separation Science,
Год журнала:
2022,
Номер
45(12), С. 2077 - 2092
Опубликована: Март 1, 2022
Antibody‐based
therapeutic
agents
and
other
biopharmaceuticals
are
now
used
in
the
treatment
of
many
diseases.
However,
when
these
administrated
to
patients,
an
immune
reaction
may
occur
that
can
reduce
drug's
efficacy
lead
adverse
side‐effects.
The
immunogenicity
be
evaluated
by
detecting
measuring
antibodies
have
been
produced
against
drugs,
or
antidrug
antibodies.
Methods
for
antibody
detection
analysis
important
during
selection
a
approach
based
on
such
drugs
is
crucial
developing
testing
new
biopharmaceuticals.
This
review
examines
approaches
detection,
measurement,
characterization.
Many
immunoassays
antigen
binding
tests,
including
homogeneous
mobility
shift
assays.
Other
techniques
capillary
electrophoresis,
reporter
gene
assays,
surface
plasmon
resonance
spectroscopy,
liquid
chromatography‐mass
spectrometry.
general
principles
each
will
discussed,
along
with
their
recent
applications
regards
analysis.
