Overview

The manufacture of a master and working cell bank and subsequent characterization of these cell banks provide the groundwork for the future production of biological products. Proper characterization assays are essential because they provide evidence that the cell banks are free of contaminants and are able to provide a solid, stable foundation to continue production processes years down the road.

Testing recommendations depend on the species of the cell line (e.g., hamster, human, chicken, E. coli, P. pastoris) and its intended use (e.g., recombinant protein production, vaccine production, gene therapy).

  • MAMMALIAN & ALTERNATIVE CELL LINES
    • Identity testing
      • Karyology
      • Barcode Analysis
      • DNA fingerprinting (STR analysis)
    • Sterility testing
    • Genetic stability testing
      • Copy number determination
      • DNA and RNA sequencing (Part 11 compliant sequencer)
      • Restriction map analysis
    • Virological safety testing
  • BACTERIA & YEAST
    • Identity testing
      • Gyrase B sequencing
      • Microbial identification and strain typing
    • Purity testing
    • Viability testing
    • Genetic stability testing
      • Copy number determination
      • DNA and RNA sequencing (Part 11 compliant sequencer)
      • Restriction map analysis
      • Retention of selectable markers
      • Retention of recombinant construct