Recombinant human factor VIII for use in the treatment of hemophilia was first introduced into clinical use in 1993. Two such products are currently available for patients: onoe manufactured jointly by Baxter Healthcare Corporation and Genetics Institute and one manufactured by Bayer-Miles. In the case of the Baxter-Genetics Institute product, the recombinant factor VIII is synthesized by cell culture expansion and production and purified by three chromatographic steps at Genetics Institute and then bulk shipped to Baxter where final formulation and distribution occurs. Final formulation using USP grade therapeutic albumin (human) followed by lyophilization affords the licensed product, Recombinate-TM. Although human serum albumin (HSA) has demonstrated an exceptional safety record with no reports of human viral transmission in association with its use, the presence of human plasma proteins in any biologic product introduces the potential for transmission of human infectious agents. To address this, Baxter Healthcare Corporation, Hyland Division, has developed an albumin-free formulation of recombinant Antihemophilic Factor (AF-rAHF) which completely eliminates the possibility of transmission of human blood-borne viruses. The purpose of this study is to verify the pharmacokinetics, safety, and efficacy of this albumin-free recombinant factor VIII.
Showing the most recent 10 out of 782 publications
