Comparison of the effect of various chemical stabilizers and lyophilization cycles on the thermostability of a Vero cell-adapted rinderpest vaccine.
The thermostability of a rinderpest vaccine produced on Vero cells was evaluated using a variety of chemical stabilizers and lyophilization protocols. Three stabilizer preparations and three lyophilization schedules were examined using accelerated stability testing at 37 degrees C. The vaccine preparation exhibiting the greatest stability at 37 degrees C was tested at three additional temperatures, 42, 45 and 56 degrees C, and an Arrhenius plot was constructed from the data. The stability of the reconstituted vaccine produced with the two most efficacious stabilizers was examined using three different diluent preparations. The stabilization method and high Vero cell virus batch titers resulted in a lyophilized vaccine which maintained the minimum required dose of log10 2.5 TCID50 tissue culture infectious dose for more than 20 weeks at 37 degrees C.
Mariner
J C
JC
Tufts University School of Veterinary Medicine, Section of International Veterinary Medicine, North Grafton, MA 01536.
House
J A
JA
Sollod
A E
AE
Stem
C
C
van den Ende
M
M
Mebus
C A
CA
D000704:Analysis of Variance; D000818:Animals; D004355:Drug Stability; D005079:Excipients; D005612:Freeze Drying; D006207:Half-Life; D006358:Hot Temperature; D012044:Regression Analysis; D012302:Rinderpest virus / Q000276:immunology*; D013696:Temperature; D014613:Vaccines, Attenuated / Q000276:immunology; D014709:Vero Cells; D014765:Viral Vaccines / Q000276:immunology*
D005079:Excipients; D014613:Vaccines, Attenuated; D014765:Viral Vaccines