operations
The facility is fitted out with state-of-the-art utilities and process equipment to manufacture erythropoietin [EPO] using proven expression and purification systems.
The skills and experience of the workforce, the quality of raw materials used in manufacturing and the quality of process equipment, plus the documentation systems in place, ensure that the quality of product will meet the highest standards of cGMP.
The Ireland manufacturing facility was officially opened on 24 June 2002 by Brian Cowen TD, the Irish Minister for Foreign Affairs, in the company of several VIPs from the Irish Government and the local community. Paul Edwards, formerly Chief Executive Officer of GeneMedix, was one of the key speakers.
GeneMedix Ireland currently employs 25 people, who are manufacturing EPO, used in chronic renal failure and oncology. GeneMedix has registered the tradename Epostim® for use in relation to EPO. The Company is currently in its clinical programme and running validation programmes for its regulatory submissions.