cGMP manufacturing–microbial system

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

Microbial cGMP Production Facility

The microbial cGMP production facility is located in the 5th floor of our building with a footage around 4,000 square feet. It consists of an inoculation suite, fermentation & harvest suite, purification suite, bulk fill room, buffer preparation room, and a wash & autoclave room. The fermentation capacity is 20L and 100L. The cell banking area is independent from the main facility area, and can provide maximum 400 vials per batch.

The Cutting Edge Equipment

  • 20 and 100L fermentor unit
  • 100/200/400L single use mixer with temperature control system
  • 10~100L semi-continuous / batch centrifuge unit
  • 10L/hr and 100L/hr high pressure homogenizer unit
  • 0.5~5 m2 Ultra Filtration concentration units
  • 3mm and 6mm low pressure column chromatographic system with 70mm~450mm columns.
  • Bulk filling package

Track Record

EirGenix has project experience using E.coli and Pichia.

Previous project experience

  • Recombinant proteins (Soluble protein, Pichia)
  • Recombinant protein complexes (Soluble protein, E.coli)
  • Pegylated recombinant proteins (Inclusion Body, E.coli)
  • Protein vaccines (Soluble protein, E.coli)
  • Biosimilars (Inclusion Body, E.coli)
  • Plasmid DNA (E.coli)

Certificates

Year

Certificate and Inspection

2013

certificated by Taiwan FDA as a cGMP facility

2014

certificated by Taiwan FDA as a PIC/S GMP facility (till now)

2017

received accreditation certificate of foreign manufacturer from Japan