Process Development

EirGenix is a contract development and manufacturing organization that performs high quality and cost-effective services supporting our clients in development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing

EirGenix has strong process development capabilities in both microbial and mammalian systems to provide our clients process development, process optimization, and process troubleshooting. We have successfully delivered results to meet clients’ requirement in product productivity, product quality, and process cost effectiveness. Our previous project experience includes recombinant proteins, plasmid DNA, fusion proteins, monoclonal antibodies, and biosimilars.

Upstream Development

Our well-established process development team is capable of optimizing clients’ process to meet regulatory and economic requirement.In the R&D stage, EirGenix provides development services from shake flask up to 50L single use bioreactor for mammalian system, up to 20L fermentor for microbial system. The upstream development services include media screening, feeding improvement, critical control parameters to develop or optimize the process from quantity and quality perspective.

  • 2L and 5L bench top bioreactors for mammalian cells
  • 50L single use bioreactors for mammalian cells
  • 2L and 20L fermentors for microbial cells
 

Downstream Development

Our downstream development team provides a comprehensive development platform for our clients.With this platform, we streamline transfer to deliver successful results for both existing and novel process development and optimization.Previous mammalian project experience includes recombinant protein, fusion protein, and monoclonal antibody. Previous microbial project experience includes recombinant protein (both inclusion body and soluble protein), pegylated protein, fusion protein, and Plasmid DNA.

  • Liquid chromatography systems: AKTA PRIME, AKTA Pilot, AKTA Avant
  • Various size columns from 1ml HiTrap to 14 cm diameter BPG column
 

Critical Equipment

  • Cell Metric
  • Flow sorter
  • Ambr® high throughput mini-bioreactor
  • 2/5L bench top bioreactors
  • 2L/20L fermentors
  • 50L single use bioreactor
  • MF & UF system (0.1m2 ~ 6 m2)
  • Disc centrifuge and continuous centrifuge
  • 316L SS refolding tank with agitator
  • Homogenizer: Microfluidizer and APV
  • Liquid chromatography systems (total 10 sets), max flow rate up to 800mL/min, and max pressure up to 50 bar
    • 5 AKTA Prime
    • 2 AKTA Pilot
    • 3 AKTA Avant 150
  • Various size columns from 0.66ml developmental column to 14 cm diameter production BPG column
  • UF/DF TFF system
  • Purity analysis
    • 3 Agilent HPLC (Agilent)
    • 1 UPLC (Waters)
  • Preformulation study
    • Lyophilizer
    • Stability chamber
  • Programmable controlled freezing and thawing system