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Retrospective Quality Assessment of Lyophilized Rabies Vaccine by Vero Cell for Human Use+ D" l8 g. T0 G; Z& \; v1 z
Chunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu4 }5 t: a: p! d. p
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Abstract
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. [1 l- W+ m4 f1 ^2 e$ x% l0 q$ N8 ~9 y6 Q* WObjective: 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.- Z. }1 D. V& z6 f% c% T
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8 X, x5 |1 w) K5 i6 ]. sKeywords! }3 Y5 w3 h, S8 _: w Y1 L9 T; C# {
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Rabies, Rabies Vaccine, Quality Analysis
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/ d/ Q. K ]0 j- B2 bDOI: https://doi.org/10.21092/jav.v14i3.121+ [% j% v+ g6 D! }$ z% d" ~
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