Hello, my name is Bernd Meibohm,
I'm a professor and Associate Dean for
Research and Graduate Studies
at the College of Pharmacy
at the University of Tennessee Health
Science Center in Memphis, Tennessee, USA.
Today I will talk about the
pharmacokinetics of therapeutic proteins.
Therapeutic proteins have gained
over the last two decades major
importance in applied pharmacotherapy
as well as in drug development.
This slides shows the top ten
medications by sales 2016, and
are therapeutic proteins.
So from the ten top medications,
eight are therapeutic proteins,
with major impacts in a variety
of different indications.
There are major differences
between therapeutic proteins and
traditional small molecule drugs.
Small molecule drugs are defined
by chemical structure and purity,
they are chemically synthesized, and
they're usually identical
from batch to batch.
In contrast to that, therapeutic proteins
are produced in living organisms,
usually in genetically modified
micro-organisms or mammalian cell lines.
Thus, they are not defined by
chemical structure and purity,
but they are defined by the production
process, and the careful
control of the production process
ultimately determines the final product.
So there is major emphasis on
the critical quality attributes
that define therapeutic proteins and
the control mechanisms that are involved
in the manufacturing process.
Thus, each product is unique and
even though they are highly similar,
not fully identical to each other.
That also means that over time,
batch-to-batch variation can
result in a product drift, where
the critical quality attributes slowly
change over time from batch to batch.