Centre for Cell Manufacturing Ireland at NUI Galway is the first facility of its’ kind on the island of Ireland

The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway is the first ever facility on the island of Ireland to receive a licence from the Irish Medicines Board to manufacture culture-expanded stem cells for human use.

This facility in Galway, opened today by Minister Seán Sherlock, positions Ireland as a global player in the regenerative medicine field and is a significant development for the med tech sector as a whole. 

There are many human diseases which have either inadequate or no effective treatments, and since 2004 researchers based at the Regenerative Medicine Institute (REMEDI) in NUI Galway have been working to develop new therapies to impact many different areas of unmet medical need.

To develop any new human therapy, the treatment must first be tested for safety and effectiveness in a series of rigorous clinical trials.  Over the past number of years REMEDI has developed the Centre for Cell Manufacturing Ireland which is a custom-built facility designed to expand stem cells for use in human clinical trials.  Now it has been successfully accredited, the Centre for Cell Manufacturing Ireland plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI. 

Today’s announcement coincides with plans for the first clinical trial using CCMI- manufactured stem cells which is being funded by the Health Research Board and Science Foundation Ireland. It will investigate the safety of using mesenchymal stem cells (MSCs) isolated from bone marrow for the treatment of critical limb ischemia, a common complication associated with diabetes and which can often result in limb amputation.  MSCs must be grown in the laboratory to generate sufficient quantities following their isolation from the bone marrow of adult donors.

President of NUI Galway Dr Jim Browne said: “developing Galway’s role as med tech hub of global standing, the Centre for Cell Manufacturing Ireland captures NUI Galway’s commitment to bring bold ideas to life. Innovation can bridge the gap between patient and provider and meet the needs of industry and the wider society in a balanced way.”    

Minister of State for Research and Innovation Seán Sherlock said that “The Centre for Cell Manufacturing Ireland is clear evidence of the potential benefits offered by this Government’s substantial investment in applied research. Stem cell technology, developed in the first instance to help patients with diseases such as diabetes, arthritis, heart disease and critical limb ischemia, can also create sustainable growth and jobs in Ireland’s smart economy by making researchers’ visions a reality.”

The Minister also said “the facility will play a key role in ensuring REMEDI’s continued success in EU funding initiatives, in particular Horizon 2020”. The Minister added that the Government, through SFI, will work to ensure that Ireland maximises its participation in the Horizon 2020 programme.

Speaking at the launch, Professor Tim O’Brien, Director of the Centre for Cell Manufacturing Ireland said “the presence of this facility in Ireland positions us well to develop new therapies for a broad array of clinical problems which do not have effective treatments today.  It will also allow us to translate discoveries from the basic stem cell research programme led by Professor Frank Barry at the Science Foundation Ireland-funded REMEDI to the clinic and to be competitive for grant funding under the Horizon 2020 programme of the EU.”  

John O’Dea, Board member of the Irish Medical Devices Association (IMDA) said “revenue from Regenerative Medicine products was approximately $1.3bn in 2013, with sales growth of 40% in 2013 alone. Nearly $1.4bn was invested in companies in this space in 2013. The Centre for Cell Manufacturing Ireland is a key step in the demonstration of national competence in this space and I look forward to seeing its continued growth to assist in developing the skillsets and techniques that will be needed to embrace the new manufacturing opportunities that this exciting area will bring.”

In addition to stem cell manufacture, Centre for Cell Manufacturing Ireland (CCMI) are offering a custom ATMP (advanced therapeutic medicinal product) manufacturing service to industry and also a cleanroom leasing service to Irish SMEs who often have difficulty in procuring cleanroom space.

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Osclaíonn an tAire Sherlock an Chéad Saoráid Déantúsaíochta Gascheall d’Úsáid an Duine in OÉ Gaillimh

Is é an tIonad do Dhéantúsaíocht Ceall Éireann in OÉ Gaillimh an chéad saoráid dá leithéid ar oileán na hÉireann

Is é an tIonad do Dhéantúsaíocht Ceall Éireann in OÉ Gaillimh an chéad saoráid dá leithéid ar oileán na hÉireann a bhfuil ceadúnas faighte aige ó Bhord Leigheasra na hÉireann chun gaschealla saothráin-forbartha a dhéanamh d’úsáid an duine.

De bharr na saoráide seo i nGaillimh, a d’oscail an tAire Seán Sherlock inniu, tá Éire mar imreoir domhanda i réimse an leighis athghiniúnaigh agus is forbairt shuntasach í seo don earnáil leighis-teicneolaíochta ar an iomlán. 

Is iomaí galar daonna a mbaineann cóir leighis neamhleor nó neamhéifeachtach leis, agus ó 2004 i leith tá taighdeoirí in Institiúid an Leighis Athghiniúnaigh (REMEDI) in OÉ Gaillimh ag obair le teiripí nua a fhorbairt chun dul i ngleic le réimsí éagsúla leighis nach bhfuil aon fhreastal déanta orthu.

D’fhonn aon teiripe nua don duine a fhorbairt, caithfear an chóireáil a thástáil ar dtús ar mhaithe le sábháilteacht agus le héifeachtúlacht i sraith trialacha cliniciúla.  Le roinnt blianta anuas tá an tIonad do Dhéantúsaíocht Ceall Éireann forbartha ag REMEDI, saoráid a tógadh go sonrach chun gaschealla a fhorbairt le húsáid i dtrialacha cliniciúla daonna.  Tá creidiúnú bainte amach anois ag an Ionad do Dhéantúsaíocht Ceall Éireann agus é mar aidhm aige gaschealla a sholáthar le húsáid i dtrialacha cliniciúla tar éis cead rialúcháin a fháil de bharr sonraí réamhchliniciúla a chuir REMEDI ar fáil. 

Tagann fógra an lae inniu ag an am céanna is atá pleananna idir lámha don chéad triail chliniciúil a úsáidfidh gaschealla de chuid an Ionaid do Dhéantúsaíocht Ceall Éireann atá á maoiniú ag an mBord Taighde Sláinte agus ag Fondúireacht Eolaíochta Éireann. Déanfaidh sé iniúchadh ar an tsábháilteacht a bhaineann le gaschealla méiseincíoma (MSCanna) a fhaightear ón smior a úsáid chun cóireáil a dhéanamh ar iscéime géag criticiúil, aimhréidh chomónta a bhaineann le diaibéiteas agus a mbíonn teascadh géag dá bharr go minic.  Caithfear MSCanna a fhás sa tsaotharlann chun méid dóthanach a ghiniúint tar éis dóibh a bheith ar leithlis ó smior deontóirí fásta.

Dúirt Uachtarán OÉ Gaillimh an Dr Jim Browne: “agus é ag forbairt ról na Gaillimhe mar lárionad leighis agus teicneolaíochta ar sheasamh domhanda, léiríonn an tIonad do Dhéantúsaíocht Ceall Éireann tiomantas OÉ Gaillimh smaointe teanntásacha a chur i bhfeidhm. Is féidir leis an nuálaíocht an bearna idir an t-othar agus an soláthróir a laghdú agus freastal ar riachtanais an tionscail agus an phobail níos leithne ar bhealach cothrom.”    

Dúirt an tAire Taighde agus Nuálaíochta Seán Sherlock, “Is fianaise soiléir é an tIonad do Dhéantúsaíocht Ceall Éireann ar na buntáistí féideartha atá ar fáil de bharr infheistíocht shuntasach an Rialtais seo i dtaighde fheidhmeach. Forbraíodh teicneolaíocht gascheall den chéad uair le cabhrú le hothair a raibh galair cosúil le diaibéiteas, airtríteas, galar croí agus iscéime géag criticiúil ag gabháil dóibh, agus is féidir leis an teicneolaíocht seo cur le fás agus le fostaíocht i ngeilleagar glic na hÉireann trí fhíseanna taighdeoirí a chur i bhfeidhm.”

Dúirt na tAire chomh maith “beidh ról lárnach ag an tsaoráid i gcinntiú go leanfaidh REMEDI ar aghaidh leis an dea-obair i dtionscnaimh mhaoinithe de chuid an AE, ‘Fís 2020’ go háirithe”. Luaigh an tAire chomh maith go mbeidh an Rialtas ag obair, trí Fhondúireacht Eolaíochta Éireann, le cinntiú go dtapóidh Éire gach deis as a rannpháirtíocht sa chlár ‘Fís 2020’.

Ag labhairt dó ag an seoladh, dúirt an tOllamh Tim O’Brien, Stiúrthóir an Ionaid do Dhéantúsaíocht Ceall Éireann, “mar gheall go bhfuil an tsaoráid seo lonnaithe in Éirinn táimid i suíomh maith le teiripí nua a fhorbairt do réimse leathan fadhbanna cliniciúla nach bhfuil cóireáil éifeachtach ar fáil dóibh faoi láthair.  Tabharfaidh sé deis dúinn chomh maith fionnachtana ón mbunchlár taighde ar ghaschealla atá á stiúradh ag an Ollamh Frank Berry in REMEDI, atá á mhaoiniú ag Fondúireacht Eolaíochta Éireann, a thabhairt ar aghaidh chuig an gclinic agus a bheith san iomaíocht do mhaoiniú deontais faoi chlár an AE ‘Fís 2020’.”  

Dúirt John O’Dea, comhalta Boird ar an Irish Medical Devices Association (IMDA) “rinneadh ioncam thart ar $1.3bn in 2013 as táirgí a bhain le Leigheas Athghiniúnach, agus tháinig fás 40% ar dhíolachán in 2013 as féin. Rinneadh infheistíocht de bheagnach $1.4bn i gcuideachtaí san earnáil seo in 2013. Is céim thábhachtach é an tIonad do Dhéantúsaíocht Ceall Éireann maidir le cumas náisiúnta san earnáil seo a léiriú agus táim ag súil le fás leanúnach a fheiceáil anseo chun cabhrú le tacair scileanna agus teicnící a fhorbairt a bheidh ag teastáil le tabhairt faoi na deiseanna déantúsaíochta nua a thabharfaidh an earnáil nua seo chun cinn.”

Chomh maith le déantúsaíocht gascheall, tá an tIonad do Dhéantúsaíocht Ceall Éireann ag cur seirbhís déantúsaíochta do ATMP (ardtáirge míochaine teiripeach) ar fáil don tionscal mar aon le seirbhís chun seomra íonghlan a thabhairt ar léas d’Fhiontair Bheaga agus Mheánmhéide Éireannacha a mbíonn deacracht acu go minic seomra íonghlan a fháil.

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