BioManufacturing Center

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