The pharmacokinetics of therapeutic proteins

Published on March 31, 2019   45 min

Other Talks in the Category: Diseases, Disorders & Treatments

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.
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The pharmacokinetics of therapeutic proteins

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