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Pharmaceutisch Weekblad

, Volume 13, Issue 1, pp 18–23 | Cite as

Preparation of lyophilized heat-treated cryoprecipitates from a small pool of plasma obtained by apheresis

  • D. P. Allersma
  • E. Roeffen
  • J. A. Van der Does
  • E. Briët
Articles

Abstract

A method was developed for the batch-wise production of small-pool lyophilized heat-treated cryoprecipitates in a regional Blood Bank. Ten vials of final product were derived from twenty 600 g apheresis plasma donations. We found 384 IU of factor VIII per vial and a specific activity of 0.20 IU per mg total protein. Production recovery was 340 IU of factor VIII per kg plasma. The method was easy to perform and gave a product of good quality.

Keywords

Blood banks Drug compounding Factor VIII Freeze drying Plasma 

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References

  1. 1.
    Anonymous. Wet inzake bloedtransfusie. Toelichting op het voorstel van januari 1987. [Blood Transfusion Act. Explanation at the proposition of January 1987]. The Hague: Staatsdrukkerij, 1987:17993.Google Scholar
  2. 2.
    Anonymous. Raming van de behoefte aan bloed en bloedprodukten in 1990 [Estimate of the need of blood and blood products in 1990]. Amsterdam: College voor de bloedtransfusie van het Nederlandse Rode Kruis, 1989.Google Scholar
  3. 3.
    Levy JA, Mitra GA, Wong MF, Mozen MM. Inactivation by wet and dry heat of aids associated retroviruses during factor VIII purification from plasma. Lancet 1985;1:1456–7.Google Scholar
  4. 4.
    McDougal JS, Martin LS, Cort SP, Mozen M, Heldebrant CM, Evatt BL. Thermal inactivation of the acquired immunodeficiency syndrome virus, human T lymphotropic virus-III/lymphadenopathy-associated virus, with special reference to antihemophilic factor. J Clin Invest 1985;76:875–7.Google Scholar
  5. 5.
    Tersmette M, De Goede REY, Over J, et al. Thermal inactivation of human immunodeficiency virus in lyophilised blood products evaluated by ID50 titrations. Vox Sang 1986;51:239–43.Google Scholar
  6. 6.
    Van der Does JA, Kothe FCHA, Smit Sibinga CTh, De Vries HR, Dorpema JW, Van de Donk HJM. Normen voor bloedbanken en bloedtransfusiediensten [Standards for blood banks and blood transfusion services]. Enschede: Bloedbank Twente Achterhoek, 1988.Google Scholar
  7. 7.
    Anonymous. Standards for Blood Banks and Transfusion Services. Arlington: American Association of Blood Banks, 1981.Google Scholar
  8. 8.
    Anonymous. Anticoagulant citrate dextrose solution. United States Pharmacopeia XXII/The National Fomulary NF XVII. Rockville: United States Pharmacopeial Convention, 1990:99–100.Google Scholar
  9. 9.
    Allersma DP, Swüste F, Briët E, Van der Does JA. Quality programme for the preparation of small-pool lyophilized heat-treated cryoprecipitates. Pharm Weekbl [Sci] 1991;13:24–32.Google Scholar
  10. 10.
    Anonymous. Statistical analysis of results of biological assays and tests. European Pharmacopoeia. Volume II. Sainte Ruffine: Maisonneuve, 1971:441–98.Google Scholar
  11. 11.
    Gornall AG, Bardawill CJ, David MM. Determination of serum protein by means of the biuret reaction. J Biol Chem 1949;177:751–66.Google Scholar
  12. 12.
    Margolis J, Eisen M. Stabilising effect of amino acids on factor VIII in lyophilised cryoprecipitate. Lancet 1984;2:1345.Google Scholar
  13. 13.
    Margolis J, Gallovich CM, Rhoades P. A process for preparation of ‘high-purity’ factor VIII by controlled pore glass treatment. Vox Sang 1984;46:341–8.Google Scholar
  14. 14.
    Margolis J, Eisen M. Preparation of stable lyophilized cryoprecipitate in the original frozen plasma bags. Vox Sang 1986;50:38–41.Google Scholar
  15. 15.
    Margolis J, Li ZP. Heat sterilisation to inactivate aids virus in lyophilised factor VIII. Aust NZ J Med 1986;16:413.Google Scholar
  16. 16.
    Piquet Y, Vezon G, Schooneman F, et al. Plasmapheresis in normal donors: comparative study of two methodologies: centrifugation and filtration. Plasma Ther Transfus Technol 1985;6:415–20.Google Scholar
  17. 17.
    Buchholz DH, Lin A, Snyder E, et al. Plasma separation using a hollow fiber membrane device. Transfusion 1986;26:145–50.Google Scholar
  18. 18.
    Rock G, Tittley P, McCombie N. Plasma collection using an automated membrane device. Transfusion 1986;26:269–71.Google Scholar
  19. 19.
    Vezon G, Piquet Y, Manier C, Schooneman F, Mesnier F, Moulinier J. Technical aspects of different donor plasmapheresis systems and biological results obtained in collected plasma. Vox Sang 1986;51(Suppl I):40–4.Google Scholar
  20. 20.
    Brettler DB, Levine PH. Factor concentrates for treatment of hemophilia: which one to choose. Blood 1989;73:2067–73.Google Scholar
  21. 21.
    Anonymous. Overzicht van het bloedgebeuren 1987 [Survey of the events around blood transfusions 1987]. Amsterdam: Centrale Medische Bloedtransfusie Commissie van het Nederlandse Rode Kruis, 1988.Google Scholar

Copyright information

© Royal Dutch Association for Advancement of Pharmacy 1991

Authors and Affiliations

  • D. P. Allersma
    • 1
  • E. Roeffen
    • 2
  • J. A. Van der Does
    • 2
  • E. Briët
    • 3
  1. 1.Central Pharmacy of the Hospitals of The HagueAC The HagueThe Netherlands
  2. 2.Red Cross Blood BankCJ The HagueThe Netherlands
  3. 3.Department of HaematologyUniversity Hospital LeidenRA LeidenThe Netherlands

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