Process Development

Strain and Cell Line Increased Expression Development:

E. coli, P. pastoris, S. cerevisae, and CHO
For project data:  Intracellular soluble; Periplasmic secreted Case studies will be available soon on these subjects.
 

Fermentation and Cell Culture Development: 

• Media formulation and optimization 
• Experimental design 
• Optimization of feeding strategies and induction

Harvest and Purification:

• TFF membrane processes (UF/MF)
• Depth filtration
• Expanded bed absorption
• Process chromatography (ion exchange, HIC, affinity, size exclusion, HA, etc.)
  

Process Optimization:

• Optimize operating parameters
• Identify “key” process parameters for further characterization 

Process Characterization:

• Create scale-down models
• Determine acceptable ranges for “key” process parameters
• Create list of critical process parameters (CPP) for validation

A case study will be available soon.

• Phase I validation studies