Inactivation of parvovirus B19 by liquid heating incorporated in the manufacturing process of human intravenous immunoglobulin preparations.
Several reports have suggested the possible transmission of human parvovirus B19 (B19) through the administration of plasma derivatives that had undergone virus inactivation by various types of heat treatment. However, none of the reports evaluated and discussed the inactivation of B19 by the heat treatment that is implemented in the individual manufacturing processes of such products. The present study evaluated the ability to inactivate B19 of liquid-heat treatment at 60 degrees C for 10 h that was incorporated in the manufacturing process of intravenous human immunoglobulin preparations. The results showed that B19 was rapidly inactivated under the conditions used for the liquid-heat treatment.
Yunoki
Mikihiro
M
Hirakata Laboratory, Research and Development Division, Benesis Corporation, Osaka, Japan. Yunoki.Mikihiro@mk.m-pharma.co.jp
Urayama
Takeru
T
Tsujikawa
Muneo
M
Sasaki
Yoshie
Y
Abe
Shunichi
S
Takechi
Kazuo
K
Ikuta
Kazuyoshi
K
D000914:Antibodies, Viral / Q000032:analysis; D004279:DNA, Viral / Q000032:analysis; D004340:Drug Contamination; D006358:Hot Temperature; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000592:standards*; D010322:Parvoviridae Infections / Q000517:prevention & control / Q000635:transmission; D016732:Parvovirus B19, Human / Q000276:immunology / Q000302:isolation & purification / Q000502:physiology*; D011092:Polyethylene Glycols; D013242:Sterilization / Q000379:methods; D014462:Ultrafiltration; D038301:Virus Inactivation
D000914:Antibodies, Viral; D004279:DNA, Viral; D016756:Immunoglobulins, Intravenous; D011092:Polyethylene Glycols