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Printable Handouts
Navigable Slide Index
- Introduction
- Top 10 medications by sales (2016)
- Small molecules vs. proteins
- Protein structure: structural diversity
- Classes of therapeutic proteins
- Central paradigm of clinical pharmacology
- Pharmacokinetics of therapeutic proteins (1)
- Enteral vs. parental administration
- Lymphatic uptake & MW after SC administration
- Pharmacokinetics of therapeutic proteins (2)
- Distribution of mAbs
- Distribution of proteins
- Pharmacokinetics of therapeutic proteins (3)
- Elimination of proteins
- Renal protein metabolism overview
- Three methods of renal protein metabolism
- Renal impairment: MW <60 kDa
- Renal impairment: MW >60 kDa
- Hepatic protein metabolism
- Pharmacokinetics of therapeutic proteins (4)
- Target-mediated drug disposition
- Target-mediated drug disposition: M-CSF
- Pharmacokinetics of therapeutic proteins (5)
- Neonatal Fc receptor (FcRn)
- Pharmacokinetics of therapeutic proteins (6)
- Immunogenicity: general considerations
- Immunogenicity: contributing factors
- ADA formation: clearance of immune complexes
- ADA formation: possible scenarios
- Neutralizing anti-drug antibodies
- Clearing anti-drug antibodies
- Sustaining anti-drug antibodies
- Summary of therapeutic protein disposition
- Literature on PK of biologics
- Thank you for your attention!
Topics Covered
- Differences in the pharmacokinetics of therapeutic proteins compared to small molecule drugs
- Classes of therapeutic proteins
- Central paradigm of clinical pharmacology
- Distribution and tissue penetration of mAbs and proteins
- Three methods of renal protein metabolism
- Hepatic protein metabolism
- Target-mediated drug disposition
- Immunogenicity: general considerations and contributing factors
- Neutralizing, clearing and sustaining anti-drug antibodies
Talk Citation
Meibohm, B. (2019, March 31). The pharmacokinetics of therapeutic proteins [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 11, 2024, from https://doi.org/10.69645/WLRG8182.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Bernd Meibohm has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
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0:00
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.
0:18
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
those highlighted
are therapeutic proteins.
So from the ten top medications,
eight are therapeutic proteins,
with major impacts in a variety
of different indications.
0:49
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
batches are,
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.