The summer of the high-potency active pharmaceutical ingredient (HPAPI) expansion continues, as yet another manufacturing specialist makes inroads to boost capacity for sensitive, in-demand drug ingredients.
After drafting plans for a phased expansion at its production campus in Swords, Ireland, back in 2022, CDMO SK Pharmteco this week celebrated the completion of two advanced manufacturing facilities at the location, which the company says will significantly boost the Swords site’s firepower for both large-scale commercial small molecules and ultra-high-potency API.
The HPAPI facility, which will also cover work on antibody-drug conjugate (ADC) payloads, has been designed to handle extremely potent compounds—with occupational exposure limits (OELs) as low as 10 ng/m3 —at batch sizes between 0.5 kg and 1.5 kg, SK Pharmteco said in an Aug. 18 release.
The new building comes equipped with glass reactor capacity up to 30 L, plus both rigid and flexible isolators and high-pressure chromatography, tray drying and freeze-drying capabilities.
SK Pharmteco also suggested that the site’s completion will enable greater continuity from clinical development to commercial production, given the new facility’s proximity to the Sword campus’s existing ultra-high potency lab and manufacturing facilities.
As for the “multi-purpose” small-molecule API facility, SK notes that the new digs add around 26.5 m3 of reactor capacity, including through the addition of three 8,000-liter glass-lined batch bioreactors. That particular facility has also been designed to accommodate future capacity and containment expansions down the line, SK Pharmteco explained.
Back in June of 2022, SK Pharmteco said it was earmarking $35 million for the initial phase of its Swords campus upgrade.
A unit of SK Holdings first got its hands on the Swords site through a deal with Bristol Myers Squibb back in 2017.
“These two facilities will expand our capacity to safely handle HPAPIs and scale critical therapies from clinical development through global commercial supply,” Declan Hunnigan, SK’s Europe small molecule site head and general manager, said of the new plants in a statement.
SK Pharmteco’s project completion in Ireland comes on the heels of several other recent HPAPI expansion moves.
Early last month, Swiss manufacturing powerhouse Lonza said it would throw down an undisclosed sum to bolster HPAPI capacity and establish new commercial-scale ADC capabilities at its hub in Visp, Switzerland.
Similarly, Eurofins CDMO Alphora several days back announced that it was growing to meet demand for both non-potent and high-potency drug ingredients. The company will specifically add 627 square feet of production space at its plant in Mississauga, Canada, which is being designed to accommodate walk-in fume hoods and 100-liter glass reactors.
As with both Lonza and Eurofins, SK Pharmteco did not disclose the final investment in its Ireland scale-up project.