operations
The facility has obtained a Good Manufacturing Practice (GMP) licence from the Irish Medicine Board and is currently undergoing expansion to gear up for commercial manufacture of its main product fitted erythropoietin [EPO]. There is an intention to introduce new projects to the facility over the coming period, and potentially to find other sites of manufacture in the locality.
Led
in Ireland by the General Manger, Conor O’Dea, a highly skilled and
experienced workforce has been established and rigorous quality systems
instigated to 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.
GeneMedix Ireland currently employs 32 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.