Process Development

 

Upstream Development

 

Our experienced process development team optimizes clients’ processes to meet regulatory and economic requirements. For R&D, we provide development services from shake flask to 50 L single-use bioreactors for mammalian systems, and up to 20 L fermentors for microbial systems. Upstream process development includes media screening, feeding strategy optimization, and control of critical process parameters to support product yield and quality in mammalian cell culture and microbial fermentation.

 

 

Mammalian Cell

  • 3 L / 5 L Bench-Top Bioreactors         
  • 50 L Single-Use Bioreactors               

Microbial Cell

  • 2 L Bench-Top Fermentors                 
  • 20 L Fermentor                                 

 

Downstream Development

 

EirGenix provides downstream process development services for biologics produced in mammalian and microbial systems, including protein purification, fusion protein purification, process optimization, and technology transfer. Our development platform combines chromatography and membrane filtration technologies to support efficient purification process development for both existing and novel products.

 

Our mammalian project experience includes recombinant proteins, fusion proteins, and monoclonal antibodies. For microbial systems, our experience covers soluble and inclusion-body recombinant proteins, PEGylated proteins, fusion proteins, and plasmid DNA.

 

 

 

 

  • MF & UF System (88 cm² ~ 0.57 m²)
  • ÄKTA chromatography systems (Prime, Pilot, Avant series) 
  • Chromatography columns (1 mL HiTrap to 14 cm diameter BPG)
  • Lyophilizer for formulation development
  • Dynamic light scattering (DLS)
  • Filter sizing system
  • HPLC / UPLC systems
  • Centrifuges
  • Spectrophotometers
  • Programmable controlled freezing and thawing systems