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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
2 {& _' E6 G3 _Chunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu. J- b9 m( @, G; S. B- x
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Objective: 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.2 b; B/ U: k2 e: m+ ]& l- {; R
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Keywords
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$ _+ H: N5 \$ m! u' i0 u; XRabies, Rabies Vaccine, Quality Analysis8 S8 Q# x: B4 `( C; a& t. U
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DOI: https://doi.org/10.21092/jav.v14i3.121 Q* _# B9 }- \- \3 J8 m& \
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