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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
! J8 f3 {/ B9 l/ L4 c0 u- \4 q! K4 eChunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu, k; U9 s- z5 [3 `& ]" a
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Abstract1 J0 ^1 I" }0 Q" N/ X# \
. c7 x" H* X: s0 K; Z7 VObjective: 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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/ [" k' e8 E, e* J; ZKeywords
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Rabies, Rabies Vaccine, Quality Analysis
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Full Text:[size=0.85em]PDF
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; D; x" ^3 Y2 j2 mDOI: https://doi.org/10.21092/jav.v14i3.1211 ~: I7 L; e) z# B& n0 v! P
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