Genetic Stability

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

You may also be interested in...

Cell Bank Manufacturing Services

More than 20 years of experience in manufacturing microbial and mammalian cell banks in compliance with current Good Manufacturing Practice (cGMP).

Cell Line Characterization Services

Design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines.