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Brexit Concerns Draw Some U.K. Businesses to Ireland

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Continuing uncertainty over Brexit has compelled a few companies to expand operations in Ireland, with more contacting the agency that promotes foreign direct investment into the Republic.

Officials of IDA Ireland cited Northern Ireland-based Almac Group, a contract development and manufacturing organization, which since the 2016 Brexit vote authorizing the U.K. to leave the European Union has established a European Campus in Dundalk, County Louth, Ireland, 40 minutes south of the company’s global headquarters in Craigavon, Northern Ireland, U.K. In April, Almac also announced plans to expand its global analytical services capabilities at its facility in Athlone, Ireland.

Also this year, the pharmaceutical and biotech consultancy Boyds, based in Crewe, U.K., cited Brexit in announcing it had opened an office on the campus of Dublin City University (DCU), within its DCU Invent commercialization and technology transfer facility that works with University researchers and entrepreneurs.

In addition, Wasdell Group, the U.K.’s leading pharmaceutical contract packaging providers, has opened its own €30 million (approximately $34 million) facility in Dundalk.

“We’re seeing a lot of interest, and Brexit isn’t decided yet, so we don’t really know what shape that will be,” said Shay Power, vice president, pharmaceuticals development with IDA’s Life Science Division with responsibility for attracting new investments in the pharmaceutical sector, told GEN. “What we’ve seen is companies that are well organized and are beginning to execute on that contingency plan that they’ve had in place for a period of time.”

“The second-tier companies are probably only starting to really get down and figure out how they’re going to manage in post-Brexit,” Power added. “A lot of companies, particularly smaller companies, have adopted a wait-and-see stance, and are hoping for the best. There is a huge amount of turmoil in the U.K. over Brexit.”

Power and Ivan Houlihan, vice president, life sciences with IDA Ireland, discussed Brexit’s impact on the Irish life sciences industry in an interview during the Biotechnology Innovation Organization (BIO) International Convention, held June 3–6 in Philadelphia.

Ireland counts about 1200 biopharma companies, and about as many companies in the medtech space that includes diagnostics developers. The Republic has long attracted U.S. and other biopharmas through selling points that include its low corporate tax rate of 12.5%, its availability of suitable locations, including those overseen by IDA Ireland; and its focus on workforce skills and training through its top-tier universities and the country’s National Institute for Bioprocessing Research and Training (NIBRT), which provides a global center of excellence for training and research in bioprocessing.

“A lot of investments”

“We’ve seen a lot of investments in the life sciences in terms of the finished product, in terms of the packaging and the warehousing, and stuff like that,” Houlihan said. “And then we’ve seen other investments that are follow-upon investments from existing clients as well.”

One such example Houlihan cited is WuXi Biologics, which in December 2018 began construction of a €325 million (about $368 million) biopharmaceuticals contract manufacturing facility in Dundalk, within IDA Ireland’s greenfield site in Mullagharlin. More than 400 jobs are anticipated at the facility, which is WuXi Biologics’ first ever manufacturing investment in Europe, and the company’s first investment of that scale anywhere outside of China.

“When complete, WuXi Biologics Ireland will be the world’s largest facility using single-use bioreactor technology,” Brendan McGrath, Ireland site head and vp manufacturing at WuXi Biologics, stated in a company brochure to prospective clients.

The company does not specifically cite Brexit in explaining its thinking behind expanding in Ireland: “Among the reasons for the decision were the availability of a highly educated and talented workforce, the existence of an established cluster of world-leading biopharmaceutical companies, a world-class research base, and the availability of a shovel-ready greenfield site in Dundalk, which will enable the facility to be ready for production during 2021.”

However, WuXi Biologics included as another reason: “Ireland’s exemplary record in working with both national and international regulators—the FDA and the European Medicines Agency (EMA) among others.” The EMA in March relocated its offices from London to Amsterdam, as a consequence of the Brexit vote.

Almac’s Dundalk campus is now operational, and includes a processing facility for commercial drug product services, a dedicated EU distribution center for clinical trial material, and a custom built QC laboratory. Since January 2019, the Dundalk facility also has capacity and regulatory approval to support storage of IMPs and clinical trial logistics.

The company won approval from Ireland’s Health Products Regulatory Authority (HPRA) last year to conduct QP batch certification and release for both clinical trial material and commercial drug product directly from the EU. In addition, the site can support the analysis of commercial drug product and provide flexible secondary labeling and packaging solutions for a broad range of finished pack presentations.

“A unique offering”

“The proximity of our U.K. facilities and new EU campus is a unique offering which offers distinct advantage to our clients and, regardless of the outcome of Brexit, our priority is for our dedicated teams to continue to deliver an uninterrupted service to our global client base,” Paul O’Connor, global vp quality, Almac Clinical Services, stated in a May 30 Q&A article posted on Almac’s website.  “Our company’s Brexit solution ensures we are ready for all outcomes, and will ensure our clients’ trials will remain unaffected, even if there are significant changes to the existing regulatory framework and transfer of product between Europe and the U.K.”

In Athlone, Almac said April 15, it will double its existing workforce by adding up to 40 jobs over the next 24 months as a result of its planned global analytical services expansion. The company is building additional laboratory space that is designed to support microbiology and GMP analysis of small and large molecules.

The 40 based in Athlone are part of a 150-person global analytical services operation that includes locations in Craigavon as well as Souderton, PA.

Wasdell Group anticipates creating 300 jobs at its new 70,000-square-foot facility within the IDA Dundalk Science and Technology Park, Mullagharlin. The new facility offers QC import testing, a variety of current and novel packaging technologies, as well as storage and distribution. The Dundalk site also incorporates serialization technology in addition to customer manufacturing solutions.

“We see ourselves as partnering with companies when they’re interested in growing and expanding internationally,” Houlihan said. “When they’re trying to find the right location for, let’s say it’s a manufacturing location, there’s not too many places in the world that can compete against Ireland to provide the kind of overall solution that we can provide.

“Being part of Europe, having the access to the manufacturing skill set, good education, good corporate tax rate, very pro-business environment, if that’s your criteria, you’re going to be down to just a handful of locations globally,” Houlihan added.

机器翻译

英国退欧的持续不确定性迫使一些公司扩大在爱尔兰的业务,更多地与促进对爱尔兰外国直接投资的机构联系。IDA Ireland 的官员提到了总部位于北爱尔兰的 Almac Group。Almac Group 是一家合同开发和制造组织,自 2016 年英国退欧投票授权英国离开欧盟以来,Almac 已在爱尔兰 Louth 郡 Dundalk 建立了一个欧洲园区,位于该公司在北爱尔兰克雷加文的全球总部以南 40 min 的地方。今年 4 月,Almac 还宣布计划扩大其在爱尔兰 Athlone 的全球分析服务能力。同样在今年,总部位于英国 Crewe 的制药和生物技术咨询公司 Boyds 宣布,Brexit 在都柏林城市大学 (DCU) 开设了一个办公室,该公司的 DCU 发明了商业化和技术转移设施,与大学研究人员和企业家合作。此外,英国领先的药品合同包装提供商 Wasdell Group 已经在 Dundalk 开设了自己的 3000 万欧元(约合 3400 万美元)的工厂。负责吸引制药领域新投资的 IDA 生命科学部门制药开发副总裁 Shay Power 告诉 GEN,“我们看到了很多兴趣,英国退欧还没有决定,所以我们并不真正知道那将是什么形状。”“我们看到的是那些组织得很好的公司,并且开始执行他们已经制定了一段时间的应急计划。Power 补充道:“二线公司可能只是开始真正走下坡路,弄清楚在英国退欧后他们将如何管理。”“很多公司,特别是较小的公司,采取了观望的姿态,希望获得最佳。英国在脱欧问题上存在巨大的动荡。"6 月 3 日-6 日在费城举行的生物技术创新组织 (BIO) 国际会议中心 (Biotechnology Innovation Organization,BIO) 大会上,Power 和 IDA Ireland 生命科学副总裁 Ivan Houlihan 在接受采访时讨论了英国退欧对爱尔兰生命科学行业的影响。爱尔兰有大约 1200 家生物制药公司,包括诊断开发人员在内的 medtech 领域的公司数量也差不多。长期以来,该共和国一直通过卖点吸引美国和其他生物危害,包括 12.5% 的低企业税率、合适地点的可用性,包括由爱尔兰国际开发协会监管的地点。并通过其顶级大学和国家生物加工研究与培训研究所 (NIBRT),将重点放在劳动力技能和培训上,NIBRT 为生物加工方面的培训和研究提供了全球卓越中心。“很多投资”Houlihan 说,“我们在生命科学领域看到了很多关于成品、包装和仓储等方面的投资。”“我们还看到了其他投资,它们也是来自现有客户的后续投资。"Houlihan 列举的一个例子是药明康德生物制剂公司,该公司于 2018 年 12 月开始在 IDA 爱尔兰位于 Mullagharlin 的 greenfield 场地内的 Dundalk 建设一个 3.25 亿欧元(约合 3.68 亿美元)的生物制药合同生产设施。该工厂预计将有 400 多个工作岗位,这也是药明康德在欧洲的首次制造投资,也是该公司在中国以外任何地方的首次如此规模的投资。“完成后,WuXi Biologics Ireland 将成为世界上最大的使用一次性生物反应器技术的工厂,”WuXi Biologics 爱尔兰工厂负责人兼生产副总裁 Brendan McGrath 在给潜在客户的公司手册中表示。该公司在解释其在爱尔兰扩张背后的想法时并未具体引用英国退欧:“做出这一决定的原因包括:拥有高学历和才华横溢的劳动力,存在已建立的世界领先的生物制药公司集群,一个世界级的研究基地,以及在 Dundalk 有一个铲子准备好的 greenfield 场地,这将使该设施在 2021 年期间准备生产。" 然而,药明康德生物制剂作为另一个原因包括:" 爱尔兰在与国家和国际监管机构——FDA 和欧洲药品管理局 (EMA) 等机构——的合作中取得了堪称典范的记录。“由于英国退欧投票的结果,EMA 在 3 月份将其办公室从伦敦迁至阿姆斯特丹。Almac 的 Dundalk 园区现已投入运营,包括一家用于商业药品服务的加工机构、一家专门用于临床试验材料的欧盟配送中心和一家定制的 QC 实验室。自 2019 年 1 月以来,Dundalk 机构还拥有支持 IMP 储存和临床试验后勤的能力和监管批准。该公司去年获得爱尔兰健康产品监管机构 (HPRA) 的批准,对直接来自欧盟的临床试验材料和商业药品进行 QP 批次认证和放行。此外,该工厂可支持商业制剂分析,并为各种成品包装规格提供灵活的二级贴标和包装解决方案。“独特的产品”“我们的英国设施和新的欧盟园区的临近是一个独特的产品,为我们的客户提供了明显的优势,无论脱欧的结果如何,我们的重点是我们的团队继续为我们的全球客户群提供不间断的服务,”Almac Clinical Services 全球质量副总裁 Paul O’Connor 在 5 月 30 日发表于 Almac 网站的问答文章中表示。4 月 15 日,Almac 在阿斯隆表示,“我们公司的脱欧解决方案确保我们为所有结果做好准备,并将确保我们客户的试验不会受到影响,即使欧洲和英国之间的现有监管框架和产品转移发生重大变化”。该公司正在建立额外的实验室空间,旨在支持小分子和大分子的微生物学和 GMP 分析。总部设在阿斯隆的 40 家公司是 150 人的全球分析服务业务的一部分,包括在克雷加文以及宾夕法尼亚州索德顿的地点。Wasdell 集团预计在其位于 Mullagharlin 的 IDA Dundalk 科技园新的 7 万平方英尺的设施中创造 300 个就业机会。新设施提供 QC 进口测试、各种当前和新型包装技术以及储存和分销。除客户生产解决方案外,Dundalk 地点还采用了序列化技术。Houlihan 说:“当公司有兴趣在国际上发展和扩张时,我们把自己看作是他们的伙伴。”“当他们试图找到合适的地点时,假设这是一个制造地点,世界上没有太多能够与爱尔兰竞争的地方能够提供我们能够提供的那种整体解决方案。“作为欧洲的一部分,拥有良好的制造技能、良好的教育、良好的企业税率和非常有利的商业环境,如果这是你的标准,你将会在全球范围内只有少数几个地方,”Houlihan 补充道。

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