Applicable for

• plasmids and fragments of antibodies for which an “off-the-shelf” method is directly available
• recombinant proteins for which a method of production has been already developed

Production scale: from 100 mg up to 10 g of purified material.

Two grades of quality proposed

• R&D production for in vitro trials (activity testing, selection of lead candidates, formulation and stability studies) and small animal testing;
• GLP production for applications requiring traceability (TOX/POC studies and IVD).

Services proposed

• Production of fragments of antibodies:
  • high cell density P. pastoris fermentation with production yields up to 8 g/L of fragments of antibodies
  • “off-the-shelf” process for rapid production of R&D grade
  • process optimization required for GLP and/or large scale production
• Production of plasmid:
  • high cell density E. coli fermentation with production yields up to 1.8 g/L of plasmid
  • optimized lysis for high supercoiled content
  • “off-the-shelf” method for rapid production with R&D or GLP grade

Deliverables

• For R&D production:
  • purified product
  • certificate of analysis
• For GLP production:
  • purified product
  • certificate of analysis
  • batch record including production method, raw materials list and production check-lists
• A process “ready-to-transfer” to GMP manufacturing.