The identity and integrity of recombinant genes has to be verified and shown to be stable throughout the production process. Stability is supported by characterization studies for mammalian or microbial cells at the end of production and comparing the attributes to those of the master cell bank.

Charles River applies the following methods to determine the genetic stability of recombinant products and to characterize plasmid products:

  • Restriction endonuclease analysis
  • Copy number determination
  • DNA/RNA/plasmid sequencing
  • Retention of recombinant construct
  • Retention of selectable marker
  • Determination of yeast prototrophy

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