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Skip to 0 minutes and 14 seconds Now, the reason I mentioned all these products and that there will be newer one and more coming out on the market. So it’s unrealistic to remember each and every biologics by chemical name. by trade name, by users. But the important thing is that we have the pharmacological principles, and the therapeutic indications or classes. If we know the pharmacological principles and pharmacological classes or therapeutic classes, then we will be able to pick up the drug information from the literature or from the published results. And then, be able to pick up the information readily. And that that’s why I want to go over… the briefly the pharmacological bases and the therapeutic indications for each and every class of the biologics.

Skip to 1 minute and 24 seconds First, the Antihemophilic factors or the AHF. AHF is naturally occurring and it’s derived from human blood. But through the advancement of recombinant technology, it is now genetically engineered from the Chinese hamster Ovary, CHO, cell line. As indicated for hemophilia, it’s a congenital blood clotting disorder.

Skip to 1 minute and 59 seconds There are two types: hemophilia A which is deficient in Clotting factor VIII; and the hemophilia B which is deficient in Clotting factor IX. And the therapeutic monitoring of these type of drugs are to monitor factor VIII or IX of, and of course, the clinical status. As you have noticed by now, I’m using biologics and drugs interchangeably and I also use protein and the peptide interchangeably. And I’m sure you’ll be able to pick up which is what as I go through the lectures. And these are the Antihemophilic factors or biologics on the market. Recombinant factor VIII, all these 5 drugs.

Skip to 3 minutes and 3 seconds And recombinant factor IX, again fewer: Benefix and Alprolix. And as you can tell, the newer product like Obizur and the Eloctate, approved in 2014. They are characterized by longer action time along with duration of action. So now let’s look at some packages for the Antihemophilic factor biologics. And here you can see different units of the antihemophilic factors, and the reason I’m showing you this slide is to draw your attention to the different doses and the units. And you you will be able to pay a whole lot of attention to the different doses and different unit.

Anti-Hemophilic Factors

Most of the recombinant factor VIII products currently on the market incorporate proteins or raw materials derived from either human or animal sources. Next-generation recombinant factor VIII for the treatment of hemophilia A is produced using a protein-free manufacturing process. By excluding proteins or raw materials derived from human or animal sources in the final product, the risk of transmission of potentially infectious agents is greatly diminished.

Recombinant AHF (r-AHF) is a recombinant anti-hemophilic factor derived from Chinese Hamster Ovary (CHO) cell line. Recombinant factor VIII is indicated for Hemophilia A, that of Factor IX for Hemophilia B. A list of then new approved r-AHF (2014) is presented Different brands of r-AHF contain different dose units, caution should be exercised to avoid dispensing error (e.g., Alprolix vs Kogenate vs BeneFix, 1000/2000/3000 iu).

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This video is from the free online course:

Pharmacotherapy: Understanding Biotechnology Products

Taipei Medical University