Livogen Pharmed Copmany

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 Genetic Stability Testing Service (For MCB, WCB and EOPC banks):

 Stability assessment of the recombinant protein producing system is a critical requirement for the regulatory approval of biopharmaceutical products. The stability and integrity of both inserted gene sequence and the transcription system need to be confirmed in order to guarantee the stable production of the proper protein. livogen  offers genetic stability testing to characterize master cell banks (MCB), working cell banks (WCB) and end of production cells (EOPC) from bacterial, yeast, insect and mammalian cell cultures. We apply the following techniques to evaluate the genetic stability of the cell lines:

 

  • Transgene insertion copy number Determination via quantitative Real-Time PCR
  • Expression stability analysis during subsequent passages at RNA level
  • Transgene stability analysis during subsequent passages
  • Restriction endonuclease analysis
  • Transgene sequence integrity confirmation by DNA sequencing
  • RNA sequencing
  • Gene banking and cloning for biopharmaceutical companies

                                                                                                                                                

 Genetic Stability Testing

Package 1

Package 2

Full Package (ICH Q5B)

 Copy number determination

 

 Expression stability analysis

 Transgene stability analysis

 

 Restriction endonuclease analysis

 

 

 DNA& mRNA sequencing

 Gene cloning