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No Detectable Alterations in Immunogenicity following Terminal Severe Dry‐Heat Treatment of High‐Purity Factor VIII (Liberate) and Factor IX (HP9) Concentrates
Author(s) -
MacGregor I. R.,
McLaughlin L. E.,
MacGregor M. C.,
Prowse C. V.,
Pepper D. S.
Publication year - 1995
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.1995.tb00367.x
Subject(s) - immunogenicity , monoclonal antibody , dry heat , antigen , chemistry , antibody , denaturation (fissile materials) , microbiology and biotechnology , immunology , biology , materials science , nuclear chemistry , composite material
We used monoclonal antibody ELISAs, antigen molecular size distribution, competition ELISA and neonatal mouse immune tolerance methods to detect potential neoantigen formation and increased immunogenicity following severe dry‐heat treatment of high‐purity factor VIII (Liberate) and factor IX concentrates. To provide positive controls, concentrates were heated in solution (70°C for 2 h) to produce denaturation on purpose. The competition ELISA applied to factor IX proved particularly useful for quantifying differences between the positive control and the dry‐heated/unheated concentrates. None of the test systems employed by us indicated any detectable neoantigen formation or any alteration in immunogenicity following terminal severe dry‐heat treatment of the high‐purity concentrates, and this finding is supported by clinical experience so far.