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0:00
Hello everyone.
Thanks for joining
part 2 of my talk
on developing monoclonal
antibody therapies
and antibody-based products.
My name is Veysel Kayser.
I'm working at the
University of Sydney
in the School of Pharmacy.
0:16
In this second part,
we will be starting
with characterization.
0:22
Monoclonal antibodies have to go
through rigorous safety
and efficacy tests.
For this, we use different types
of biophysical or
analytical tools to ensure
the product is
characterized properly
and it meets the expected
standard for human use.
These methods are categorized
into different sections here.
Such as optical methods.
Those could be
microscopic methods such
as electron microscopes
or optical microscopes.
It could be separation methods
such as analytical
ultracentrifugation
or chromatographic
methods such as
HPLC or electrophoretic methods.
It could be spectroscopic
methods such
as UV-vis spectroscopy
or fluorescence,
light scattering, mass
spec, NMR and so on.
Lastly, it could be
calorimetric methods.
For example, it could be
differential scanning
calorimeter.
Different methods would provide
different characteristics of
the protein or formulation.
Combining all this
information together
will present a better
picture of the system.
1:29
Some of these important
characteristics are
shown on this slide.
These needs to be
characterized properly,
such as chemical and
physical stability,
which may include denaturation,
aggregation,
fragmentation, oxidation,
deamination or other types
of product formation.
Amino acid sequence
has to be checked.
Post-translational modifications
including glycosylation
has to be characterized.
Long-term storage profile
has to be found out
and different types of
temperature sensitivity data
has to be shown.
For this, accelerated studies
have to be conducted.
Target binding studies
and toxicities studies are also
part of this
characterization process.
