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Expands global capabilities to meet customer demand
On October 2, 2014, Ireland’s Prime Minister Enda Kenny, and Richard Bruton, Minister for Jobs, Enterprise & Innovation for Ireland, joined West Chairman and CEO Don Morel to announce that West plans to expand its global manufacturing operations to include a new site in Waterford, Ireland. The event was held at Tower Hotel, The Mall, Waterford.
The new facility will produce packaging components for insulin injector cartridges and other high value packaging components, in order to meet growing demand from pharmaceutical and biotech customers. Once operational, this new site could bring approximately 150 new jobs to Waterford and is intended to grow to support additional jobs through expansions in the future.
“With diabetes emerging as one of the fastest growing diseases globally, our pharmaceutical customers are expanding their production lines for injectable insulin. To meet this growing demand, we are announcing an expansion today that will help us address this need and continue to serve this critical patient population,” said Donald E. Morel, Jr., West’s Chairman and Chief Executive Officer. “In the future, we intend for this site to be a center of excellence for advanced packaging components to meet the future needs of our customer base for a range of sophisticated injectable therapies.”
“Waterford, Ireland, is an ideal setting for this new plant, given its business-friendly environment and the growing health science industry in the area,” Morel added. “On behalf of West’s Board of Directors, I would like to thank the many representatives of Waterford City, the Irish Government and the Irish Development Agency for their support.”
An Taoiseach Enda Kenny TD said, “I am delighted with this announcement of a new manufacturing facility in the South East by West Pharmaceutical Services which will create 100 construction jobs during its development and an initial 150 new jobs when operational. It is a massive boost for Waterford and the entire South East and I am happy that Government was able to assist through the work of the IDA. The Government is determined to secure economic recovery by incentivizing job creation and further investment in the area. Today’s announcement continues our strong track record on attracting employers in the medical devices sector and we will continue to prioritize Government support for sectors with real growth potential through our Action Plan for Jobs.”
Construction is planned to begin in early 2015 on the 44-acre site at Knockhouse on Old Kilmeaden Road in Waterford, subject to the project obtaining requisite planning and zoning approvals, which the Company believes will occur later this year. This site will be a center of excellence for our proprietary elastomeric sheeting , which is used to package insulin for use in pen injectors. Future plans include additional manufacturing space for West’s proprietary injectable component product lines, which are integral to many injectable and dosage forms. With these planned expansions, the plant eventually could accommodate between 250 to 300 jobs total.
West has maintained a presence in Ireland since 2005 with a manufacturing and development center in Dublin, which is the European headquarters for The Tech Group, a West subsidiary that specializes in providing device design, development and manufacturing services for pharmaceutical and med-tech customers. Employing over 230 people at its Mulhuddart, Dublin facility, it is also undergoing an expansion as a result of securing a number of significant customer programs.
<strong>My greatest achievement is founding West without Borders*</strong><br />I’ve worked at West for 21 years! One of my friends approached me and said he would love it if I joined West. He kept telling me what a great company West was and eventually I agreed. I loved the job in the sales department because I got to work with a lot of bold personalities. I’m very outgoing and talkative and so are account managers.
<p>West is thrilled to announce that Lisa Bakazias, VP, Operations, Manufacturing Strategy, was recently named as our 2018 HBA Luminary.</p>
Critical quality attributes (CQAs) of biologic drug products can be affected by multiple factors throughout the product lifecycle, including the container closure and delivery systems. Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, discussed containment and delivery system compatibility with biologic drug products along with regulatory considerations in her presentation Establishing Safety of Container Closure and Delivery Device Systems at the PepTalk 2017 conference. Evaluating potential impacts early, holistically, and throughout bioprocessing can facilitate decisions at each step that will minimize risks to CQAs and safety.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
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