There are many types of factor concentrates available for treatment of hemophilia .Factor VIII (or Factor IX) concentrates made up using recombinant DNA technology in lab is considered as safe for treatment of hemophilia A and B.
These recombinant factors are made by inserting the DNA encoding the human protein into mammalian cells grown in culture. They are purified and processed and are non-plasma derived products.
Prior to approval by the Food and Drug Administration for using recombinant DNA-derived blood clotting factors, clotting factors produced from human blood plasma were used in treatment of hemophilia. Though the anti-hemophilic factor derived from human blood plasma is inexpensive but it carried the risk of transmitting serious diseases such as Hepatitis B and HIV.
The first anti-hemophilic factor to be artificially produced in lab using recombinant DNA technology was Factor IX, which was produced using transgenic Chinese hamster ovary cells in 1986.The antihemophilic factor(recombinant) is then highly purified by several steps involving biotechnology process. The production of Factor IX by recombinant DNA technology in the lab eliminates the risk of transmission of serious diseases such as hepatitis and HIV.
The Food and Drug Administration declared publicly the licensing of first recombinant DNA- derived clotting factor for use in treatment of hemophilia A in a press release dated December 10, 1992. However, the committee asked for more clinical trials to be carried on in previously untreated patients because antibodies that inhibited the activity of anti-hemophilic factor were found in some patients. Though the antibodies were not strong enough to cause any serious problem but more data is needed to evaluate the effect of recombinant DNA derived clotting factor.
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