Mammalian Cell Culture Development

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