Development of Vero cell-derived inactivated Japanese encephalitis vaccine.
We have established a manufacturing system for a Vero cell-derived inactivated Japanese encephalitis vaccine at a 500l scale. The production system involves expansion of Vero cells using microcarrier, followed by virus infection. Except for an additional purification step, the downstream purification processes are similar to those used for the current mouse brain-derived vaccine; cell removal, concentration and removal of low-molecular weight impurities by membrane filtration, formalin-inactivation, sucrose density gradient ultracentrifugation, and Sulfate-Cellulofine column chromatography are conducted. The antigen obtained from the manufacturing system was highly purified and its physico-chemical and immunological properties were comparable with those of antigen derived from mouse brains. Our system is very simple and could be easily scaled-up to allow vaccine production at a several thousand litre scale.
Sugawara
Keishin
K
Kikuchi Research Center, The Chemo-Sero Therapeutic Research Institute, Kumamoto 869-1298, Japan. sugawara@kaketsuken.or.jp
Nishiyama
Kiyoto
K
Ishikawa
Yuji
Y
Abe
Motoharu
M
Sonoda
Kengo
K
Komatsu
Kazuhiro
K
Horikawa
Yoshikane
Y
Takeda
Kengo
K
Honda
Tomitaka
T
Kuzuhara
Shoji
S
Kino
Yoichiro
Y
Mizokami
Hiroshi
H
Mizuno
Kyosuke
K
Oka
Tetsuya
T
Honda
Kennosuke
K
D000818:Animals; D000956:Antigens, Viral / Q000032:analysis; D002522:Chlorocebus aethiops; D004664:Encephalitis Virus, Japanese / Q000276:immunology / Q000302:isolation & purification / Q000648:ultrastructure; D004797:Enzyme-Linked Immunosorbent Assay; D005285:Fermentation; D022321:Japanese Encephalitis Vaccines / Q000276:immunology / Q000302:isolation & purification*; D051379:Mice; D008854:Microscopy, Electron; D009500:Neutralization Tests; D012449:Safety; D015164:Vaccines, Inactivated / Q000276:immunology / Q000302:isolation & purification; D014709:Vero Cells; D014776:Virus Cultivation
D000956:Antigens, Viral; D022321:Japanese Encephalitis Vaccines; D015164:Vaccines, Inactivated