Image representing the equipment used in mammalian cell culture development at Scorpion's large molecule and biologics manufacturing and development facility

Process Development

Mammalian Cell Culture Development

Cell culture process development activities at Scorpion span all phases of product development, from small-scale, preclinical evaluation and “proof-of-concept” studies to the development of cGMP-compliant, clinical-scale processes, through to commercial-scale process development for cell therapy manufacturing.

Service Offerings
  • Use of Process Excellence Six Sigma methodology (e.g., Design of Experiments) for the optimization of upstream processes
  • Application of QbD principles throughout development
  • Identification of important process parameters via FMEA analysis
  • Process optimization using miniaturized bioreactors
  • Comparison of 2D vs. 3D technologies
  • Cell bank development
  • Ability to provide extensive process development and optimization studies throughout all stages of process development from 250mL to 2000L
  • Use of advanced cell culture process control strategies
  • Process monitoring capabilities including metabolic profile analysis
  • Optimization of cell harvest process (centrifugation, kSep, microfiltration, etc.)
  • Aseptic process validation/simulation studies
  • Scale-down process validation studies
  • Cryopreservation process optimization using controlled rate freezing strategies