Technical Bulletin

cGMP Protein Purification

Laureate Pharma offers both purification development as well as purification at scale. Our cGMP facilities in Princeton, New Jersey, are validated, and house all the appropriate laboratories and necessary equipment for both processes. In addition, our staff conduct viral clearance validation studies at qualified off-site laboratories.

• Monoclonal antibodies and recombinant proteins
• Chromatography by affinity, ion exchange, hydrophobic interaction and size-exclusion methods, as well as filtration via micro, ultra, and nanopore filters.

Protein Purification System

• Automated chromatography systems
• Scale: gm to kg
• Variety of chromatography resins
• Validated systems, Part 11 compliant

Protein Purification Services

• cGMP production scale purification
  • Aseptic processing
  • Closed, sanitary system, sterile buffer and collection bags,aseptic connections
• Buffer preparation
• QC testing of raw materials, intermediates,and bulk product
• Process and viral clearance validation
• Integrated process development programs