title: No detectable alterations in immunogenicity following terminal severe dry-heat treatment of high-purity factor VIII (Liberate) and factor IX (HP9) concentrates.
abstract: 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 degrees 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.
authors: National Science Laboratory, Scottish National Blood Transfusion Service, Edinburgh, UK.
authors: I R
authors: IR
authors: MacGregor
authors: L F
authors: LF
authors: McLaughlin
authors: M C
authors: MC
authors: MacGregor
authors: C V
authors: CV
authors: Prowse
authors: D S
authors: DS
authors: Pepper
mesh_terms: D000941:Antigens / Q000097:blood*; D000998:Antiviral Agents / Q000276:immunology*; D002850:Chromatography, Gel; D003890:Desiccation; D004797:Enzyme-Linked Immunosorbent Assay; D005164:Factor IX / Q000302:isolation & purification*; D005167:Factor VII / Q000302:isolation & purification*; D006358:Hot Temperature; D006801:Humans; D007108:Immune Tolerance; D011485:Protein Binding
chemical_list: D000941:Antigens; D000998:Antiviral Agents; D005167:Factor VII; D005164:Factor IX