Academic Journal of Agriculture & Life Sciences, 2024, 5(1); doi: 10.25236/AJALS.2024.050108.
Baoqin Jiang, Yan Cui, Mingxue Qi, Jun Liu, Yan Shi, Su Liu, Chenming Liu, Jing Ren, Dejie Feng
Lanzhou Institute of Biological Products Co. Ltd., Lanzhou, 730046, China
The results showed that the appearance inspection and moisture content of the reference material for oral rotavirus live vaccine met the requirements; The titration results for 12 years showed that the reference titers of oral rotavirus live vaccines stored below -20 ℃ were within the quality control range of 6.2-7.2lgCCID50/mL, with an annual detection mean of 6.6-6.8lgCCID50/mL and an annual detection standard deviation of 0.17-0.23lgCCID50/mL. Trend analysis shows that the reference titer of the oral rotavirus live vaccine is stable and there is no downward trend. The reference material for oral rotavirus live vaccines currently in use has stable and effective performance, ensuring the accuracy and reliability of virus titer detection results for oral rotavirus live vaccines and oral trivalent reconstituted rotavirus attenuated live vaccines (Vero cells) in daily use. This can provide assurance for the quality control of the two types of rotavirus vaccines.
Oral live rotavirus vaccine, Reference substance, Appearance, Moisture content, Virus titer, Overall trend analysis
Baoqin Jiang, Yan Cui, Mingxue Qi, Jun Liu, Yan Shi, Su Liu, Chenming Liu, Jing Ren, Dejie Feng. Performance evaluation of reference substance for oral live rotavirus vaccines. Academic Journal of Agriculture & Life Sciences (2024) Vol. 5 Issue 1: 52-56. https://doi.org/10.25236/AJALS.2024.050108.
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