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

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

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