title: Evaluation of wet pasteurization of a factor VIII concentrate produced by controlled-pore silica adsorption.
abstract: In the routine production of a factor VIII concentrate (produced by adsorption of contaminating proteins in cryoprecipitate to controlled-pore silica and concentration of the factor VIII effluent by ultrafiltration) the terminal dry-heat treatment has been replaced by pasteurization in the liquid state. High effectivity of this procedure with respect to virus inactivation was demonstrated using a variety of both lipid- and protein-enveloped model viruses, including HIV. Pair-wise quality control of dry-heated and pasteurized product revealed no significant differences, except in the composition of the formulation buffer. In a clinical study in which 17 patients with haemophilia A participated the pasteurized product was well tolerated and in vivo recovery and half-life of factor VIII were in the same (normal) range as found for the dry-heated counterpart.
authors.affiliation: Central Laboratory of The Netherlands Red Cross Blood Transfusion Service, Amsterdam.
authors.forename: H
authors.initials: H
authors.lastname: Hiemstra
authors.forename: C E
authors.initials: CE
authors.lastname: Nieuweboer
authors.forename: M A
authors.initials: MA
authors.lastname: Idoe
authors.forename: J E
authors.initials: JE
authors.lastname: Claassen
authors.forename: A H
authors.initials: AH
authors.lastname: Vos
authors.forename: M
authors.initials: M
authors.lastname: Tersmette
authors.forename: P F
authors.initials: PF
authors.lastname: Strengers
authors.forename: J
authors.initials: J
authors.lastname: Over
authors.forename: E P
authors.initials: EP
authors.lastname: Mauser-Bunschoten
authors.forename: H
authors.initials: H
authors.lastname: Heijboer
mesh_terms: D000327:Adsorption; D005169:Factor VIII / Q000302:isolation & purification / Q000592:standards* / Q000627:therapeutic use; D006801:Humans; D011786:Quality Control; D012822:Silicon Dioxide; D013242:Sterilization / Q000379:methods; D014462:Ultrafiltration; D014780:Viruses / Q000302:isolation & purification
chemical_list: D012822:Silicon Dioxide; D005169:Factor VIII