DNA assay for recombinant pharmaceutical substances using the real-time PCR technique

被引:1
作者
Skoblov, M. Yu. [1 ]
Shibanova, E. D. [1 ]
Kovaleva, E. V. [1 ]
Bairamashvilli, D. I. [1 ]
Skoblov, Yu. S. [1 ]
Miroshnikov, A. I. [1 ]
机构
[1] Russian Acad Sci, Shemyakin Ovchinnikov Inst Bioorgan Chem, Moscow 117997, Russia
关键词
insulin; real-time PCR; pharmaceutical substance; residual DNA; QUANTIFICATION;
D O I
10.1134/S1068162010010115
中图分类号
Q5 [生物化学]; Q7 [分子生物学];
学科分类号
071010 ; 081704 ;
摘要
A real-time PCR procedure is proposed for assaying E. coli residual DNA in the pharmaceutical substance of human recombinant insulin. For the quantitative analysis of the DNA content, an amplification of fragments of the bla gene plasmid DNA and E. coli genomic DNA of the 16S RNA gene were used. The contents of plasmid and genomic DNA were detected both in intermediates at various stages of the insulin purification process and in the finished product.
引用
收藏
页码:104 / 108
页数:5
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