Comparison of two methods for content analysis of vaccine particles in freeze-dried human rabies vaccine (Vero cells) bulk and final bulk
10.13200/j.cnki.cjb.004271
- VernacularTitle:两种分析冻干人用狂犬病疫苗（Vero细胞）原液及半成品疫苗颗粒含量方法的比较
- Author:
YANG Xue
- Publication Type:Journal Article
- Keywords:
Rabies vaccine;
Vaccine bulk;
Final bulk;
Virus particles;
Inter-batch consistency;
Content analysis
- From:
Chinese Journal of Biologicals
2024;37(07):866-872
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare and analyze two methods for determination of vaccine particle content in freeze-dried human rabies vaccine(Vero cells)bulk and final bulk,and to provide experimental basis for establishing standard detection method for particle content and purity of rabies vaccine products.Methods The samples were subjected to vaccine particle cracking,BCA quantification,and size exclusion chromatograghy-high performance liquid chromatography(SEC-HPLC)analysis. BCA-SEC relative area method and BCA-SEC vaccine particle standard curve method were used to detect the total protein concentration of the bulk and final bulk,separately,and the content of vaccine particles was quantitatively analy-zed. Finally,the detection results of the two methods were compared and analyzed.Results The content of vaccine particles in freeze-dried human rabies vaccine bulk was determined to be within 256-305 μg/mL by the two methods,with an average value of 267-285 μg/mL,and the relative standard deviations(RSDs)ranged from 5. 8% to 10. 2%,with good consistency between two methods. The content of vaccine particles in freeze-dried human rabies vaccine final bulk was determined to be in the range of 149-169 μg/mL by the two methods,with an average value of 152-164 μg/mL,and the two methods showed the RSDs between 0. 9%-4. 7% with good consistency.Conclusion The measured value by BCA-SEC standard curve method deviates less from the expected value and is closer to the actual situation of samples,so it is recommended to use this method as a reference for enterprises.
