Download PDF
Thromb Haemost 1981; 46(02): 511-514
DOI: 10.1055/s-0038-1653399
Original Article
Schattauer GmbH Stuttgart

Long-Term Tolerance and Recovery of β-Propiolactone/Ultraviolet (βPL/UV) Treated PPSB in Chimpanzees

W Stephan
1   The Biotest-Serum-Institut GmbH, Frankfurt/Main, West Germany
,
R Kotitschke
1   The Biotest-Serum-Institut GmbH, Frankfurt/Main, West Germany
,
A M Prince
2   The Lindsley F. Kimball Research Institute of The New York Blood Center, New York, N.Y., USA and Vilab II, The Liberian Institute for Biomedical Research, Robertsfield, Liberia
,
B Brotman
2   The Lindsley F. Kimball Research Institute of The New York Blood Center, New York, N.Y., USA and Vilab II, The Liberian Institute for Biomedical Research, Robertsfield, Liberia
› Author Affiliations
Further Information

Publication History

Received 16 March 1981

Accepted 11 May 1981

Publication Date:
05 July 2018 (online)

  PDF Download  Permissions and Reprints

Summary

Recent experiments have shown that a preparation of PPSB (factor IX concentrate) derived from βPL/UV treated plasma was not infectious in chimpanzees with respect to hepatitis B and non-A, non-B. To answer the question whether the βPL/UV treatment influences the tolerance and efficacy of the PPSB concentrate, long-term application of PPSB-Biotest was carried out in chimpanzees. After 10 applications of 25 U factor IX/kg at weekly intervals, no signs of intolerance were observed by measurement of blood pressure during i. v. application and by means of skin-testing. Determination of coagulation factor activity during the application period revealed the same factor IX recovery at the beginning and at the end of the study.

Keywords

Factor IX concentrate - Immunogenicity - Recovery - β-Propiolactone/Ultraviolet treatment
 

  • References

  • 1 Stephan W, Kotitschke R. Prothrombinkomplex-Konzentrat aus kalt-sterilisiertem Plasma. Forschungsergebnisse der Transfusionsmedizin und Immunhämatologie 1977; 4: 72-75
    PubMedGoogle Scholar
  • 2 Stephan W. Hepatitis-free and stable human serum for intravenous therapy. Vox Sang 1971; 20: 442-457
    CrossrefPubMedGoogle Scholar
  • 3 Bauer HW, Mellin HE, Grabs GH. Über die Bedeutung der postoperativen Zufuhr von Plasmaproteinen. Infusionstherapie 1980; 7: 301-304
    PubMedGoogle Scholar
  • 4 Prince AM, Stephan W, Brotman B, Van den Ende MC. Evaluation of the effect of betapropiolactone/ultraviolet irradiation (BPL/UV) treatment of source plasma on hepatitis transmission by factor IX complex in chimpanzees. Thromb Haemostas 1980; 44: 138-142
    PubMedGoogle Scholar
  • 5 Stephan W, Prince AM, Berthold H. Inaktivierung von Hepatitis B-Viren in Human-Plasma und Serum durch β-Propiolacton (βPL)/UV-Behandlung. Forschungsergebnisse der Transfusionsmedizin und Immunhämatologie 1980; 7: 559-570
    PubMedGoogle Scholar
  • 6 Prince AM, Stephan W, Brotman B. β-propiolactone/ultraviolet irradiation: Quantitative studies on effectiveness for inactivation of hepatitis B virus. Abstract. Symposium on Viral Hepatitis. New York, N. Y.: 28.03.1981
    Google Scholar
  • 7 Stephan W. Über die Hydrolyse von β-Propiolacton in Seren und Plasmen. Z Klin Chem Klin Biochem 1969; 7: 518-520
    PubMedGoogle Scholar
  • 8 Stephan W, Haug E. Unterschiedliche Wirksamkeit von β-Propiolacton bei der Sterilisation von Esterase-aktiven und -inaktiven Seren und Plasmen. Zentralbl Bakteriol 1970; 215: 381-385
    PubMedGoogle Scholar
  • 9 Sonneborn HH, Stephan W. Untersuchungen zur Verträglichkeit von β-Propiolacton-behandeltem und UV-bestrahltem Rattenserum. Infusionstherapie 1980; 7: 145-147
    PubMedGoogle Scholar
  • 10 Kornhuber B. Intravenöse Immunglobulin-Langzeittherapie bei Kindern. Monatsschr Kinderheilk 1979; 127: 20-22
    PubMedGoogle Scholar
  • 11 Kotitschke R, Stephan W. Fractionating citrate’stabilized plasma. US Patent Ser No 75867
    PubMedGoogle Scholar
  • 12 Ovary Z. Passive cutaneous anaphylaxis. In: Ackroyd, Immunological Methods 1964. Blackwell: London-Oxford-Edinburgh; 1964: 259-283
    Google Scholar
  • 13 Sonnebom HH, de Week AL, Toffler O. Vergleichende Studie über die Immunogenität von Plasmaersatzlösungen auf Gelatinebasis im Tierexperiment. Infusionstherapie 1978; 5: 41-49
    PubMedGoogle Scholar
  • 14 Ouchterlony Ö. Diffusion in gel methods for immunological analysis. Prog Allergy 1958; 5: 1-78
    PubMedGoogle Scholar
  • 15 Davies OL, Goldsmith PL. Statistical methods in research and production. Chapter 6: Analysis of variance. In: Statistical Methods in Research and Production, with special reference to the chemical industry, published for ICI. Longman Group Ltd.; London: 1972: 121-177
    Google Scholar