Russian Journal of Bioorganic Chemistry

, Volume 36, Issue 1, pp 104–108 | Cite as

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

  • M. Yu. Skoblov
  • E. D. Shibanova
  • E. V. Kovaleva
  • D. I. Bairamashvilli
  • Yu. S. Skoblov
  • A. I. Miroshnikov
Experimental Articles
  • 101 Downloads

Abstract

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.

Key words

insulin real-time PCR pharmaceutical substance residual DNA 

Abbreviations

API

active product ingredient

RHP

recombinant hybrid protein

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Copyright information

© Pleiades Publishing, Ltd. 2010

Authors and Affiliations

  • M. Yu. Skoblov
    • 1
  • E. D. Shibanova
    • 1
  • E. V. Kovaleva
    • 1
  • D. I. Bairamashvilli
    • 1
  • Yu. S. Skoblov
    • 1
  • A. I. Miroshnikov
    • 1
  1. 1.Shemyakin-Ovchinnikov Institute of Bioorganic ChemistryRussian Academy of SciencesMoscowRussia

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