SK Pharmteco opens two new manufacturing facilities at Swords Campus in Ireland

IRELAND—SK Pharmteco, a contract development and manufacturing organization (CDMO), has opened two new manufacturing facilities at its campus in Swords, Ireland.

This expansion enhances its capability to produce high-potency active pharmaceutical ingredients (HPAPIs), antibody-drug conjugate (ADC) payloads, and commercial small-molecule APIs.

The company announced the completion on August 18, following plans unveiled in 2022 for a phased expansion of the Swords site.

SK Pharmteco said the new facilities will strengthen the campus’s ability to support both large-scale commercial production and highly potent drug substances.

New HPAPI facility

The new HPAPI facility is designed to handle extremely potent compounds with occupational exposure limits as low as 10 ng/m³.

It will support batch sizes ranging from 0.5 kg to 1.5 kg and will also manufacture ADC payloads, according to the company.

The facility includes glass reactors with capacities of up to 30 litres, as well as rigid and flexible isolators that help protect workers when handling highly potent materials.

It also features high-pressure chromatography, tray drying and freeze-drying capabilities.

SK Pharmteco said the facility’s location alongside its existing ultra-high-potency laboratory and manufacturing operations will support a smoother transition from clinical development to commercial production.

The expanded infrastructure is intended to allow customers to progress drug candidates through development and into larger-scale manufacturing at the same campus.

Expanded small-molecule capacity

Alongside the HPAPI facility, SK Pharmteco has completed a multi-purpose small-molecule API plant that adds approximately 26.5 m³ of reactor capacity.

The expansion includes three 8,000-litre glass-lined batch reactors, increasing the site’s ability to manufacture APIs at commercial scale.

SK Pharmteco also designed the facility to accommodate additional capacity and containment upgrades as production requirements grow.

In June 2022, the company announced that it had allocated $35 million to the initial phase of its Swords campus expansion.

SK Pharmteco, a unit of SK Holdings, acquired the Swords site from Bristol Myers Squibb in 2017.

The company has since developed the location as a manufacturing centre for pharmaceutical ingredients and drug development services.

“These two facilities will expand our capacity to safely handle HPAPIs and scale critical therapies from clinical development through global commercial supply,” said Declan Hunnigan, SK Pharmteco’s Europe small-molecule site head and general manager.

Broader HPAPI expansion

SK Pharmteco’s expansion follows several recent investments in high-potency manufacturing capacity across the pharmaceutical industry.

Last month, Swiss CDMO Lonza announced plans to increase HPAPI capacity and establish new commercial-scale ADC capabilities at its Visp site in Switzerland. The company did not disclose the investment amount.

Meanwhile, Eurofins CDMO Alphora recently announced plans to expand its Mississauga, Canada, facility to meet demand for both conventional and high-potency APIs.

The project will add 627 square feet of production space, including walk-in fume hoods and 100-litre glass reactors.

SK Pharmteco has not disclosed the total investment in its latest Swords expansion.

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