Evaluation of wet pasteurization of a factor VIII concentrate produced by controlled-pore silica adsorption.
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silica and concentration of the factor VIII effluent by ultrafiltration) the terminal dry-heat treatment has been replaced by pasteurization in the liquid state.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.
Hiemstra
H
H
Central Laboratory of The Netherlands Red Cross Blood Transfusion Service, Amsterdam.
Nieuweboer
C E
CE
Idoe
M A
MA
Claassen
J E
JE
Vos
A H
AH
Tersmette
M
M
Strengers
P F
PF
Over
J
J
Mauser-Bunschoten
E P
EP
Heijboer
H
H
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
D012822:Silicon Dioxide; D005169:Factor VIII