Process Development

EirGenix provides end-to-end CDMO services for the development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial scale. Leveraging strong process development capabilities in microbial and mammalian systems, we deliver optimized solutions across recombinant proteins, plasmid DNA, fusion proteins, monoclonal antibodies, and biosimilars.

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 development includes media screening, feeding optimization, and critical parameter control to enhance both product quantity and quality.

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

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.

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