Irish biopharmaceutical manufacturing is booming, according to The National Institute for Bioprocessing Research and Training (NIBRT). The organization says the emerald isle has the talent, tech, and infrastructure to support firms looking to make drugs in an English- speaking EU country.

Ireland started trying to attract more biopharmaceutical manufacturers in 2010 amid concerns its then small molecule API-focused pharma sector would fall off the “patent cliff” or struggle against low-cost competition.

The plan was to attract higher tech, complex biomanufacturing through tax incentives, training programs, and infrastructure investment.

The efforts worked according to NIBERT’s Killian O’Driscoll, who added biopharma firms invested $10 billion in Irish facilities in the past decade.

“For example, BMS will manufacture their immuno-oncology products at a new $900m facility in Dublin, MSD is currently constructing a facility to manufacture Keytruda, and Takeda is commissioning a single-use facility for the company’s rare disease portfolio,” he said.

Biopharma 4.0

And the efforts continue. The Biopharma 4.0 Alliance, set up by NIBRT and Boston Consulting, established what O’Driscoll calls a “digital demonstrator” to help companies adopt cutting-edge production systems.

“The demonstrator will cover the latest industry 4.0 technologies in manufacturing, quality control, quality assurance, and cross plant operations. These technologies will be seamlessly integrated with core operating processes to enable proof-of-concept studies on new innovations and new ways of working,” he said.

The Irish Government has identified cell therapy manufacturing as a key target. In October, NIBRT and the Government published a white paper called “The case for cell and gene therapy manufacturing in Ireland” setting out a plan to ensure Ireland is an attractive location for the production of such therapies.

Part of the strategy is to encourage development of cell and gene therapy production skills.

O’Driscoll said, “NIBRT has established a collaboration with GE Healthcare to deliver the first of a series of competency-based hands-on training in this area from January 2020 onwards focusing on advanced cell technologies most notably CAR-T cell manufacturing.”

Logistics are a key consideration for any company making autologous cell therapies and personalized medicines. The ability to harvest cells, manufacture a therapy, and return it to the patient as quickly as possible is vital.

The fact Ireland is an island should not discourage cell therapy firms from choosing the country as a manufacturing location, according to O’Driscoll.

“The manufacturing and supply chain expertise established in Ireland is seen as a key factor in winning these investments with Ireland’s excellent transport links across the EMEA region seen as strongly beneficial,” he said.

He pointed to Takeda’s decision to make a regenerative medicine at a new €30m facility near Dublin as evidence of the efficacy of Ireland’s logistics infrastructure, explaining: “This therapy has a complex and time-critical supply chain across the EMEA region.”

Post Brexit opportunities

Next year Ireland’s nearest neighbor, the U.K., is likely to withdraw from the EU. Brexit will impact U.K. manufacturers in various ways, requiring, for example, that they transfer batch testing to an EU member site.

U.K.-made biopharmaceuticals and cell therapies will also need to be checked at EU Borders, potentially delaying shipment. Also, U.K. medical exports may be subjected to tariffs if the U.K. cannot strike an agreement with the bloc.

Ireland is a well-placed alternative for biopharmaceutical companies looking to export to the EU’s €260bn pharmaceutical market, according to O’Driscoll.

“Ireland’s position as an English-speaking country at the heart of the EU is an important part of the country’s value proposition in attracting investment in biopharma manufacturing,” he said. “Ireland’s membership of the EU provides manufacturers with regulatory, legislative, and supply chain certainty for access to the European market.”

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