Stability characteristics of freeze-dried human live virus vaccines.
Freeze-drying (lyophilization) of biologically active materials such as human live virus vaccines is an accepted method of preserving potency. Since freeze-drying does not assure total stability, a formal system of monitoring stability, i.e., potency, has been established. Two experimental desings are utilized: (1) Long term studies to duplicate normal use storage at -20 degrees C and 2-8 degrees C and (2) Accelerated studies which predict long term stability through regression analysis using the Arrhenius equation. Data summarizing stability experience over a long period of study will be presented.
D004355:Drug Stability; D004356:Drug Storage; D005612:Freeze Drying; D008458:Measles Vaccine / Q000592:standards; D009108:Mumps Vaccine / Q000592:standards; D012411:Rubella Vaccine / Q000592:standards; D013696:Temperature; D014765:Viral Vaccines / Q000592:standards*
D008458:Measles Vaccine; D009108:Mumps Vaccine; D012411:Rubella Vaccine; D014765:Viral Vaccines