Process Development

Microbial Fermentation Development

Scorpion has extensive experience in the development of recombinant E. coli fermentation processes for the optimal expression of soluble proteins, proteins expressed as insoluble inclusion bodies, therapeutic proteins and enzymes, immune toxins, bacterial subunit vaccines as well as plasmid DNA.

Service Offerings
  • E. coli recombinant expression platforms to produce therapeutic proteins and plasmid DNA
  • Use of Process Excellence Six Sigma methodology (e.g., Design of Experiments) for the optimization of upstream fermentation processes
  • Application of QbD principles throughout development
  • Identification of important process parameters via FMEA analysis
  • Processes scalable from bench scale to 50L
  • Use of advanced cell culture process control strategies
  • Process monitoring capabilities including metabolic profile analysis
  • Optimization of cell lysis (mechanical vs. chemical)
  • Optimization of cell harvest separation process
  • Scale-down validation studies

Scorpion’s process development staff has extensive experience optimizing microbial fermentation batch and fed-batch processes for the production of protein biologics, therapeutic enzymes and plasmid DNA. We utilize an expandable, benchtop, single-use, stirred bioreactor system for statistical design of experiments (DOE) and process optimization studies.