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Thromb Haemost 1986; 55(03): 402-405
DOI: 10.1055/s-0038-1661573
Original Article
Schattauer GmbH Stuttgart

A Pasteurised Concentrate of Human Plasma Factor XIII for Therapeutic Use

L Winkelman
The Plasma Fractionation Laboratory, Churchill Hospital, Oxford, England (Headquarters Laboratory: Blood Products Laboratory, Elstree, Herts, UK)
,
G E Sims
The Plasma Fractionation Laboratory, Churchill Hospital, Oxford, England (Headquarters Laboratory: Blood Products Laboratory, Elstree, Herts, UK)
,
M E Haddon
The Plasma Fractionation Laboratory, Churchill Hospital, Oxford, England (Headquarters Laboratory: Blood Products Laboratory, Elstree, Herts, UK)
,
D R Evans
The Plasma Fractionation Laboratory, Churchill Hospital, Oxford, England (Headquarters Laboratory: Blood Products Laboratory, Elstree, Herts, UK)
,
J K Smith
The Plasma Fractionation Laboratory, Churchill Hospital, Oxford, England (Headquarters Laboratory: Blood Products Laboratory, Elstree, Herts, UK)
› Author Affiliations
Further Information

Publication History

Received 18 February 1986

Accepted 22 April 1986

Publication Date:
18 July 2018 (online)

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Summary

A therapeutic concentrate of factor XIII containing both A and B sub-units has been prepared from 300 kg pools of human plasma. The process starts from a cold-ethanol fraction from cryoprecipitate supernatant and therefore does not interfere with the recovery of other clinically valuable plasma proteins. Factor XIII is purified approximately 600-fold from plasma by precipitation with sodium citrate and by the removal of fibrinogen by brief heating. The product has been pasteurised in sorbitol solution to inactivate blood-borne viruses, ultrafiltered to remove sorbitol, adsorbed with bentonite and freeze-dried in a formulation meeting requirements for intravenous injection.

Keywords

Factor XIII - Plasma fractionation - Pasteurisation
 

  • References

  • 1 Losowsky MS, Miloszewski K. Management of patients with congenital deficiency of fibrin stabilising factor (factor XIII). In: Proceedings of the 16th International Congress of Haematology. Seno S, Takaku F, Irino S. (eds.). Excerpta Medica 1977 Kyoto; Japan: 1976
    Search in Google Scholar
  • 2 Lorand L, Losowsky MS, Miloszewski K JM. Human Factor XIII: Fibrin-Stabilizing Factor. In: Progress in Haemostasis and Thrombosis. Spaet TH. (ed.) 5 245-290 Grune and Stratton; New York: 1980
    Search in Google Scholar
  • 3 Gornall AG, Bardawill CJ, David MM. Determination of serum protein by meahs of the biuret reaction. J biol Chem 1949; 177: 751-766
    PubMedSearch in Google Scholar
  • 4 Zall DM, Fisher D, Garner MQ. Photometric determination of chlorides in water. Analyt Chem 1956; 28: 1665-1668
    CrossrefPubMedSearch in Google Scholar
  • 5 Saffran M, Denstedt OF. A rapid method for the determination of citric acid. J biol Chem 1948; 175: 849-855
    PubMedSearch in Google Scholar
  • 6 Peterson GL. A simplified method for the analysis of inorganic phosphate in the presence of interfering substances. Analyt Biochem 1978; 84: 164-172
    CrossrefPubMedSearch in Google Scholar
  • 7 Snape TJ, Griffiths D, Vallet L, Wesley ED. The assay of prekallikrein activator in human blood products. Dev biol Standard 1979; 44: 115-120
    PubMedSearch in Google Scholar
  • 8 Curtis CG, Lorand L. Fibrin stabilizing factor (factor XIII). Meth Enzymol 1976; 45: 177-191
    PubMedSearch in Google Scholar
  • 9 Duckert F, McDonagh J. Report of the Subcommittee on Factor XIII (ISTH). Thromb Haemostas 1979; 41: 460-461
    PubMedSearch in Google Scholar
  • 10 Smith JK, Winkelman L. A concentrate of factor XIII from human plasma. In: Factor XIII and Fibronectin. Egbring R, Klingemann H-G. (eds.) 51-55 Die Medizinische Verlagsgesellschaft; Marburg: 1983
    Search in Google Scholar
  • 11 Heimburger N, Schwinn H, Gratz P, Liiben G, Kumpe G, Her-chenhahn B. FaktorVIII-Konzentrat, hochgereinigt und in Losung erhitzt. ArzneimForsch 1981; 31: 619-622
    PubMedSearch in Google Scholar
  • 12 Auerswald G, Novakova-Banet A, Heimburger N, Popp M. New pasteurised factor IX concentrate: Manufacturing, Clinical Efficacy and Hepatitis-Safety. XVI. nameInt Cong of the World Federation of Haemophilia, Rio de Janeiro 1984
    PubMedSearch in Google Scholar
  • 13 MacLeod AJ, Cuthbertson B, Foster PR. Pasteurisation of factor VIII and factor IX concentrates. pubna18th Congress of the International Society of Blood Transfusion, Munich 1984
    PubMedSearch in Google Scholar
  • 14 Ng PK, Dobkin MB. Pasteurisation of antihemophilic factor and model virus inactivation studies. Thromb Res 1985; 39: 439-447
    CrossrefPubMedSearch in Google Scholar
  • 15 Horowitz B, Wiebe ME, Lippin A, Vandersande J, Stryker MH. Inactivation of viruses in labile blood derivatives. II. Physical methods. Transfusion 1985; 25: 523-527
    CrossrefPubMedSearch in Google Scholar
  • 16 Daly HM, Haddon ME. Submitted for publication.
    PubMed