Applicable for

• recombinant proteins produced in E.coli (cytoplasmic or periplasmic expression) and P. pastoris (secretion).

Services proposed

• Construction of protein expression systems (E. coli or P. pastoris strains):
  • vectors design including selection between different strains, vectors, selection markers, promoters, secretion signals, coding sequences, modes of codon optimization.
  • transformation, clones screening and selection of the best producing clones.
• Fermentation:
  • screening of optimal process conditions
• Harvest and extraction:
  • optimization of the harvest conditions for cells or media recovery
  • development of the extraction conditions: high pressure treatment, osmotic shock, chemical lysis
  • preparation, solubilization and refolding of inclusion bodies
• Chromatography:
  • high throughput screening of resins and chromatographic conditions
  • validation of resins and fine-tuning of process conditions using small-scale columns
• Ultrafiltration and microfiltration:
  • membranes and process conditions screening
• Industrial transfer:
  • scaling-up studies (chemical engineering)
  • multi-parameters process monitoring

Deliverables

• Research Cell Banks (50 vials) with certificate of analysis
• Purified material for in vitro trials (activity testing, formulation studies…).
• Development report including:
  • method of production
  • operating parameters at the different scales of production
• A process transferable to the Xpress Biologics GLP platform.
• A process “ready-to-transfer” to GMP manufacturing.