Evaluation of current sterility tests for human live viral vaccines.
Current sterility tests for human viral vaccines were evaluated. A total of 43 lots of bulk suspension of live viral vaccines (measles, mumps, rubella and oral poliomyelitis) produced by six manufacturers in Japan were evaluated for bacteriostatic and mycoplasmastatic activities. Some of them showed fairly high bacteriostatic and mycoplasmastatic activities, due to antibiotics added during vaccine production. It was concluded that the current sterility test for mycoplasmas is not reliable to detect viable mycoplasmas in live viral vaccines.
Sasaki
T
T
Department of Safety Research on Biologics, National Institute of Health, Tokyo, Japan.
Harasawa
R
R
Shintani
M
M
Fujiwara
H
H
Sasaki
Y
Y
Horino
A
A
Kenri
T
T
Ishii
K
K
Chino
F
F
D000128:Acholeplasma laidlawii / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D000900:Anti-Bacterial Agents / Q000494:pharmacology; D001412:Bacillus subtilis / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D004340:Drug Contamination; D005069:Evaluation Studies as Topic; D006801:Humans; D008826:Microbial Sensitivity Tests; D016982:Micrococcus luteus / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D009174:Mycoplasma / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D013211:Staphylococcus aureus / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D014765:Viral Vaccines / Q000494:pharmacology / Q000592:standards*
D000900:Anti-Bacterial Agents; D014765:Viral Vaccines