Cell Counting

Reach Our Mammalian Experts:

mammalian@lonza.com

We have extensive experience with regulatory agencies in both the United States and Europe and have validated a large number of processes for production in mammalian systems. The scope of the studies performed is dependent on your needs and the current regulatory guidelines. Typically, the studies performed would include a genetic characterization of the cell line, various process limit evaluations, a range of raw material expiry experiments and a fermentation consistency series. As some of this information can be collected during a typical cell culture program, we recommend an early meeting with the regulatory authority to discuss your regulatory package.

In addition, our experience includes validating purification processes for acceptable critical process parameter operating ranges, for the reuse of purification components, and for the ability of the process to remove process related impurities, DNA and viruses.

R&D Process Validation Services Include:

  • Characterization of cells at the limit of in vitro cell age
  • Cell line stability assessment
  • Genetic characterization of the cell line
  • Additional cell bank characterization
  • Process limits studies
  • Product specific assay validations
  • Process performance consistency studies
  • Biochemical comparability
  • Reference standard characterization and elucidation of structure
  • Reference standard stability study
  • Evaluation of virus reduction
  • Evaluation of DNA reduction
  • Evaluation of resin re-use
  • Stability of process intermediates

 

Return to other Process R&D Services