[Article in Chinese]
Jou R, Kan S, Yang WJ, Huang C, Chang MK, Liau MY
Division of Biologics' Product Production, National Institute of
Preventive Medicine, Taipei, Taiwan, R.O.C.
Chung Hua Min Kuo Wei Sheng Wu Chi Mien I Hsueh Tsa Chih 1996
Feb;29(1):57-64
In order to prolong shelf-life and improve the quality of the vaccine
product, not only an effective stabilizer but also a more proper dosage
form has been sought. The stability of a Japanese encephalitis (JE)
vaccine produced from mouse brain along with a variety of stabilizers
and lyophilization protocols was evaluated. Without any stabilizers
added, almost 90% of the antigenicity would vanish after freeze-drying
process. Comparative studies of various compounds, including
carbohydrates, amino acids, peptides and medium 199, on both
antigenicity preservation and thermostability of the vaccine were
carried out. The results indicated that the best reconstituted vaccines
were prepared with two stabilizer formulations, sucrose and
sucrose/gelatin. They were further examined by accelerated stability
test at room and higher temperatures. The sucrose-added lyophilized
vaccine can retain its original antigenicity for more than 60 days both
at 37 degrees C and 45 degrees C. We conclude the thermostability
efficiency of each of the stabilizers tested is as that follows: sucrose
> sucrose/gelatin > gelatin/medium > gelatin.