Abstract：Objective To study the comparability of accelerated stability between cell factory and rotary bottle culture processes of live attenuated measles vaccine cells by forced degradation test. Methods Measles vaccine single harvests and bulks produced by cell factory and rotary bottle culture processes, 3 lots respectively, were kept at 25 ℃ for 10 d. Final products produced by 2 processes, 3 lots respectively, were kept at 37 ℃ for 10 d. Virus titers were tested according to China pharmacopoeia and enterprise quality standard. Virus degradation curves of products by 2 processes were compared by Minitab 19. Results All degradation curves showed heat sensitivity. Virus titers of single harvests produced by 2 process were 1.51 vs, 1.56 lg 50% cell culture infective dose (CCID50)/ml, 1.33 vs. 1.33 lg CCID50/ml, and 1.54 vs. 1.54 lg CCID50/ml; titers of bulks were 1.20 vs. 1.43 lg CCID50/ml; titers of final products were 1.33 vs. 1.30 lg CCID50/ml. Virus degradation curves of products by 2 processes were similar. Conclution Measles vaccines processed by cell factory culture and rotary bottle culture have similar accelerated stability.
2020, Vol. 43 
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