Therapeutic factor XIII preparations and perspectives for recombinant factor XIII

Seminars in Thrombosis and Hemostasis
H E Karges, H J Metzner

Abstract

With the increasing availability of human plasma this source was used to substitute for the production of factor XIII concentrate from placenta. Prior to changing the source material, the virus safety in accordance with the Committee for Proprietary Medicinal Products (CPMP) guidelines and the half-life were investigated. Concerning the virus safety, the following cumulative log 10 clearance factors were obtained: human immunodeficiency virus (HIV) > or = 18.9, herpes simplex virus (HSV-1) > or = 21.5, polio > or = 19.1, bovine viral diarrhea virus (BVDV) > or = 13.3. Half-life studies of factor XIII from plasma in comparison with factor XIII from placenta were done in rabbits by determination of the antigen and in patients with congenital factor XIII deficiency by determination of the activity and antigen. In rabbits, the terminal half-life of the antigen was 78.2 hours for factor XIII from placenta and 87.0 hours for factor XIII from plasma. In patients the half-lives were similar: 9.2 days for activity and antigen of factor XIII from plasma and 8.5 days (activity) versus 9.4 days (antigen) for the placenta-derived factor XIII. Some further clinical studies with factor XIII concentrates are also reviewed. Newer developments c...Continue Reading

Citations

May 4, 1999·The Journal of Experimental Medicine·T NollH M Piper
Sep 22, 2001·Journal of Biomolecular Structure & Dynamics·A AmbrusL Fésüs
Dec 3, 1999·British Journal of Haematology·R Anwar, K J Miloszewski

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