The latest phase, which includes undisclosed support from IDA Ireland, will build on Genzyme's existing sterile fill/finish manufacturing capabilities at the Waterford campus, expand the site's quality control (QC) laboratories, introduce softgel capsule manufacturing and provide new office space.
The investment will create 170 jobs in manufacturing, quality and engineering, taking Genzyme's total headcount in Waterford up to more than 600, and will significantly increase manufacturing capacity at the site over the next three years, said the company and the IPA.
The announcement was a coup for the County Waterford region, which will also see 100 new high-level positions created in Dungarvan over the next five years as US company Lancaster Laboratories capitalises on last year's acquisition of Irish laboratory Microchem (now Lancaster Laboratories Europe).
A subsidiary of Thermo Fisher Scientific, Lancaster supplies outsourced testing services to the pharmaceutical, biotechnology and environmental sectors.
Another 165 jobs will come over five years from a €65m investment by Israeli generic manufacturer Teva Pharmaceuticals in its existing Waterford facility.
This initiative, announced in March, was also supported by IDA Ireland, which has energetically pursued foreign investment in pharmaceutical manufacturing, research and development.
Announcing the Genzyme initiative, Irish Minister for Enterprise, Trade and Employment Micheál Martin noted the life sciences sector was " a crucial component of Ireland's economic landscape.
Half of the announcements and investments by overseas companies so far this year have been in this sector and in regional locations throughout the country ".
Martin Bamforth, senior vice-president, corporate operations and pharmaceuticals for Genzyme, described the Waterford expansion as a " ringing endorsement of the positive experiences we have had there since the initial announcement almost seven years ago of our plans for Ireland ".
The enhancements to Genyme's biological fill and finish operations at Waterford include the addition of a second isolated filling line, three more lyophilisers and associated upgrades as well as new utilities and support areas.
The expansion is to meet increased demand for the company's biological products such as the Gaucher Disease treatment Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa) for Pompe disease, and Thymoglobulin (Anti-thymocyte Globulin (Rabbit)) for the treatment of acute renal transplant rejection.
Design work on this project has already begun and planning permission has been sought to extend the 6,800 sq m building to accommodate the extra equipment, which will quadruple existing capacity to over 250 fills per year.
Construction is expected to be underway this summer, with completion scheduled for late 2009, followed by a start-up, commissioning and validation phase that should see the facilities ready for commercial production in mid-2011.
At the same time, the Waterford site infrastructure will grow significantly with 5,600 sq m of new offices, cafeteria and associated facilities, together with the expansion of the existing QC laboratories.
The extra laboratory space will double existing capacity, with additional microbiology, chemistry, stability and associated support areas, Genzyme said.
Design work is underway on all of these developments, with construction expected to start this summer and completion slated for the summer of 2009.
The provision of softgel oral dose capacity within Genzyme's newly validated second oral doage facility at Waterford is to satisfy demand for Hectorol, the company's doxercalciferol capsule formulation for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD).
Design work is well advanced for this €6m programme, with completion expected in 2009.
As Genzyme pointed out, the latest wave of investment is the fourth major development at the 37-acre Waterford site, which by 2010 will have absorbed total capital investment of more than €410 million.
The first phase was a tableting suite with packaging lines for the manufacture of Renagel (sevelamer hydrochloride), which controls serum phosphorus in CKD.
The Waterford facility has been shipping the product out to dialysis patients worldwide since 2003.
The biologics fill finish facility at Waterford started commercial supplies of Thymoglobulin to global markets in 2006 and the second oral dose plant is due to begin operations this year.
The new product launches (both biologicals and oral-dose formulations) planned for 2008 will bring to eight the total number of Genzyme products being supplied globally from Waterford, the company noted.
The recent votes of confidence in County Waterford as a manufacturing and laboratory base from Genzyme, Teva and Lancaster Laboratories are a tonic for what has been a rather variable pharmaceutical investment trend in Ireland over the last year or so.
While there have been significant gains, such as Merck & Co's recent choice of Carlow in south east Ireland for a new €200m vaccines and biologics facility, or GlaxoSmithKline's decision last year to locate a €23m manufacturing plant for over-the-counter medicines in County Waterford, there have also been some disappointments.
In March 2007, for example, Sanofi-Aventis announced it was shutting down its manufacturing plant in Waterford to trim off excess capacity in its production network.
Last October Amgen indefinitely postponed plans for a €71m manufacturing facility in Cork, while in December Abbott Vascular said it would close down its Galway plant, citing " significant improvements in manufacturing efficiency " and " current market conditions " in the stent sector.