|
|
楼主 |
发表于 2026-2-8 12:09:30
|
显示全部楼层
Retrospective Quality Assessment of Lyophilized Rabies Vaccine by Vero Cell for Human Use
# }( E" Y8 i1 d! q) l7 zChunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu
* d- E5 J4 R, F. ^& V/ w- G. y S8 p
Abstract
1 N" v9 o( B' S; X' \6 y, G# v, j4 k3 Y5 ], T, ^2 j. \3 G6 k* `; H
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.) ?4 e% I1 L/ G8 F* U; h
* y6 A( x7 y7 e7 }/ d
w4 p+ c3 k5 j {
Keywords2 o- A' r5 `& q- q
+ E! V7 p! }' S, _1 x7 L, ^$ HRabies, Rabies Vaccine, Quality Analysis5 A- C& U3 ?! Y! l. e' ^, z4 Y
# n0 y w3 @' ]8 Y/ S1 r- \1 N* D, v2 K
Full Text:[size=0.85em]PDF! |. L V) i" b
' F; j6 c3 }+ P& K
% o$ B( C% i4 k6 IDOI: https://doi.org/10.21092/jav.v14i3.121; _* ~( r* Z2 c) _
7 V4 H) h$ L: ]5 L) } |
|