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. NanoCinna 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 sequencing

 RNA sequencing

 

 Gene cloning

 

 

 

Cell Line Identification:

Characterization of cell lines utilized in production of biopharmaceuticals or for research purposes is a prerequisite for the manufacture or the research processes. Inter-species and intra-species Cross-contamination and misidentification of cell lines are frequent incidents that pose serious threats on the quality of biopharmaceuticals produced from these cell lines. We offer cell line identification service to validate the identity and purity of cell lines used by biopharmaceutical companies or research institutes by the following techniques:

  • Karyology
  • STR DNA profiling
  • Species-specific PCR

 

Mycoplasma Detection Service (For MCB, WCB and EOPC banks, and raw materials):

Mycoplasma is a hidden and frequent contaminant of cell cultures. Mycoplasmas can pass through filters used to prevent bacterial contamination due to its small size, and poses the risk of spreading to all the cultures in a laboratory. It is critical that all new cell cultures entering a laboratory and all cell banks are tested for the presence of Mycoplasma. NanoCinna offers the mycoplasma detection service based on the following methods:

  • Culture isolation method (the agar and broth procedure)
  • Fluorescent DNA detection method
  • PCR method