Making a therapeutic choice: human versus recombinant fractions - can we do it?
New manufacturing methods have resulted in production of higher purity human-derived products and recombinant factors with less human- or animal-derived reagents or stabilizers for the treatment of congenital coagulation disorders. In addition, new viral inactivation processes are being used to reduce the chance of viral contamination. Preferred treatment approaches are moving toward using newer-generation agents. At the same time, rationale exists for continuing fractionation of all types of products, based on considerations including cost, product availability, safety issues, and specific clinical situations for which a recombinant or high-purity product is not available. These issues and others are reviewed in the context of making a therapeutic choice.
Aledort
L M
LM
Mt. Sinai Medical Center, New York, NY 10029, USA. louis.aledort@mountsinai.org
D001779:Blood Coagulation Factors / Q000235:genetics / Q000627:therapeutic use*; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D011994:Recombinant Proteins / Q000235:genetics / Q000627:therapeutic use
D001779:Blood Coagulation Factors; D011994:Recombinant Proteins