Plasma derivatives and recombinant DNA-produced coagulation factors
- Arthur J Silvergleid, MD
Arthur J Silvergleid, MD
- Section Editor — Transfusion Medicine
- Affiliate Associate Professor, Department of Pathology and Cell Biology
- University of South Florida, College of Medicine
- Medical Director, OneBlood, Inc.
Plasma derivatives are products manufactured from human plasma by plasma fractionation techniques. Although dozens of proteins can be so purified, some are considered orphan drugs, and many are not widely used or available.
An introduction to these plasma derivatives, including those manufactured using recombinant DNA techniques, will be presented here (eg, immune globulins, coagulation proteins, and protease inhibitors). Viral inactivation of blood products is discussed separately. (See "Pathogen inactivation of blood products".)
An overview of the preparation and use of plasma "components" (ie, those prepared by differential centrifugation techniques, including fresh frozen plasma and cryoprecipitate) is presented separately. (See "Clinical use of Cryoprecipitate" and "Clinical use of plasma components".)
Fibrin sealant (fibrin "glue"), a two-component system in which a solution of concentrated fibrinogen and factor XIII is combined with a solution of thrombin and calcium in order to form a coagulum, is discussed separately. (See "Fibrin sealant".)
HISTORY AND METHODOLOGY
During World War I surgeons developed a better understanding of shock when organ failure resulted from large volume blood loss, and by the late 1930s methods for freeze-drying plasma had been developed. The use of such plasma required mixing, under battlefield conditions, with sterile water, a time-consuming process. In addition, pooled, freeze-dried plasma frequently transmitted serum hepatitis.
- Starr D. Again and again in World War II, blood made the difference. The Smithsonian Magazine, Washington, DC, March 1995. p.124.
- Ofosu FA, Freedman J, Semple JW. Plasma-derived biological medicines used to promote haemostasis. Thromb Haemost 2008; 99:851.
- Blümel J, Schmidt I, Willkommen H, Löwer J. Inactivation of parvovirus B19 during pasteurization of human serum albumin. Transfusion 2002; 42:1011.
- Arroyo V, Guevara M, Ginès P. Hepatorenal syndrome in cirrhosis: pathogenesis and treatment. Gastroenterology 2002; 122:1658.
- Kreil TR, Mc Vey JK, Lei LS, et al. Preparation of commercial quantities of a hyperimmune human intravenous immunoglobulin preparation against an emerging infectious disease: the example of pandemic H1N1 influenza. Transfusion 2012; 52:803.
- POOL JG, GERSHGOLD EJ, PAPPENHAGEN AR. HIGH-POTENCY ANTIHAEMOPHILIC FACTOR CONCENTRATE PREPARED FROM CRYOGLOBULIN PRECIPITATE. Nature 1964; 203:312.
- Lubetsky A, Hoffman R, Zimlichman R, et al. Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation. Thromb Res 2004; 113:371.
- Riess HB, Meier-Hellmann A, Motsch J, et al. Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation. Thromb Res 2007; 121:9.
- Kempton CL, White GC 2nd. How we treat a hemophilia A patient with a factor VIII inhibitor. Blood 2009; 113:11.
- Barnett B, Kruse-Jarres R, Leissinger CA. Current management of acquired factor VIII inhibitors. Curr Opin Hematol 2008; 15:451.
- Viel KR, Ameri A, Abshire TC, et al. Inhibitors of factor VIII in black patients with hemophilia. N Engl J Med 2009; 360:1618.
- Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med 2013; 369:2313.
- Powell J, Shapiro A, Ragni M, et al. Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates. Br J Haematol 2015; 168:113.
- Mahlangu J, Powell JS, Ragni MV, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood 2014; 123:317.
- Levi M, Toh CH, Thachil J, Watson HG. Guidelines for the diagnosis and management of disseminated intravascular coagulation. British Committee for Standards in Haematology. Br J Haematol 2009; 145:24.
- Tiede A, Tait RC, Shaffer DW, et al. Antithrombin alfa in hereditary antithrombin deficient patients: A phase 3 study of prophylactic intravenous administration in high risk situations. Thromb Haemost 2008; 99:616.
- Konkle BA, Bauer KA, Weinstein R, et al. Use of recombinant human antithrombin in patients with congenital antithrombin deficiency undergoing surgical procedures. Transfusion 2003; 43:390.
- HISTORY AND METHODOLOGY
- Available preparations
- - Plasma protein fraction
- IMMUNE GLOBULINS
- Intramuscular immune serum globulin
- Intravenous immune globulin
- Hyperimmune globulins
- COAGULATION FACTORS
- Fibrinogen concentrate
- Prothrombin complex concentrates
- Purified human plasma-derived factor IX concentrate
- Activated PCCs
- Factor VIII concentrates and Von Willebrand factor
- - Porcine factor VIII
- Protein C concentrate
- RECOMBINANT COAGULATION FACTORS
- Factors VIII and IX
- Factor VIIa
- Activated protein C
- PROTEASE INHIBITORS
- C1-esterase inhibitor
- Alpha-1 antitrypsin