Establishment, verification and application of detection method for size distribution of residual DNA fragments in vaccine products based on MultiNA microchip electrophoresis technology
10.13200/j.cnki.cjb.004413
- VernacularTitle:基于微芯片电泳技术的疫苗产品残留DNA片段大小分布检测方法的建立、验证及应用
- Author:
YUAN Yue
- Publication Type:Journal Article
- Keywords:
Residual DNA;
Fragment size;
MultiNA microchip electrophoresis technology;
Biological product
- From:
Chinese Journal of Biologicals
2025;28(02):204-209
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for determination of residual DNA fragments based on Multi NA microchip electrophoresis system,thus analyzing the size distribution of DNA fragments in a rapid way.Methods Based on Multi NA microchip electrophoresis system,a method for determination of the size distribution of residual DNA fragments was established,and the specificity,detection range and precision of the method were verified.Furthermore,the method was applied for the detection of the size of residual DNA fragments in the bulks and finished products of Sabin strain inactivated poliomyelitis vaccine (IPV).Results This method showed good specificity,with the detection range of 0-10 000 bp and the CVs of precision detection less than 20%.The results showed that the sizes of residual DNA fragments in Sabin strain IPV bulks were about 400 and 500 bp,accompanied with no detection in finished products.Conclusion A method based on Multi NA microchip electrophoresis technology for determination of residual DNA fragments was established,which might provide a reference for determination of the size distribution of residual DNA in biological products.
