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发表于 2026-2-8 12:09:30
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Retrospective Quality Assessment of Lyophilized Rabies Vaccine by Vero Cell for Human Use
8 T8 B7 p7 ^. m2 ~$ @, E( q. L3 r$ XChunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu
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Abstract
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% X6 L6 J8 g' H% f0 S2 JObjective: A retrospective analysis of critical quality attributes was conducted to evaluate product quality and manufacturing process control capability of lyophilized rabies vaccine (Vero cell) for human use during 2014-2018. Methods: Statistical analysis was performed on three critical quality evaluation parameters: potency assay, residual bovine serum albumin content, and moisture content. Quality trends and batch-to-batch consistency were assessed by integrating these results with the company's annual process performance index. Results & Conclusion: All critical parameter test results, including potency, residual bovine serum albumin, and moisture content, conformed to standard specifications. Most results remained within annual mean ±3SD, indicating favorable inter-lot consistency. All process performance index values were ≥1.33, demonstrating adequate process control capability.
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Keywords1 c9 X! r* q7 z. [) u
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Rabies, Rabies Vaccine, Quality Analysis
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Full Text:[size=0.85em]PDF
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DOI: https://doi.org/10.21092/jav.v14i3.121/ r! |, v# m' d- q& y# O) j. d; ]9 z
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