The summer of the high-potency active pharmaceutical ingredient (HPAPI) expansion continues, as yet another manufacturing specialist makes inroads to boost capacity for the sensitive and in-demand drug ingredients.<\/p>\n
After drafting plans for a phased expansion at its production campus in Swords, Ireland, back in 2022, CDMO SK Pharmteco this week celebrated<\/a> the completion of two advanced manufacturing facilities at the location, which the company says will significantly boost the Swords site\u2019s firepower for both large-scale commercial small molecules and ultra-high-potency API.\u00a0<\/p>\n The HPAPI facility, which will also cover work on antibody-drug conjugate (ADC) payloads, has been designed to handle extremely potent compounds\u2014with occupational exposure limits (OELs)\u00a0as low as\u00a010 ng\/m3\u00a0\u2014at batch sizes between 0.5 kg and 1.5 kg, SK Pharmteco said in an Aug. 18 release.\u00a0<\/p>\n 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.\u00a0<\/p>\n SK Pharmteco also suggested that the site\u2019s completion will enable greater continuity from clinical development to commercial production given the new facility\u2019s proximity to the Sword campus\u2019s existing ultra-high potent\u00a0lab and\u00a0manufacturing\u00a0facilities.\u00a0<\/p>\n As for the \u201cmulti-purpose\u201d small-molecule API facility, SK notes that the new digs add around 26.5 m3\u00a0of 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.\u00a0<\/p>\n Back in June of 2022, SK Pharmteco said it was earmarking<\/a> $35 million for the initial phase of its Swords campus upgrade.\u00a0<\/p>\n A unit of SK Holdings first got its hands on<\/a> the Swords site through a deal with Bristol Myers Squibb back in 2017.\u00a0<\/p>\n \u201cThese two facilities will expand our capacity to safely handle\u00a0HPAPIs\u00a0and scale critical therapies from clinical development through global commercial supply,\u201d Declan Hunnigan, SK\u2019s Europe small molecule site head and general manager, said of the new plants in a statement.\u00a0<\/p>\n SK Pharmteco\u2019s project completion in Ireland comes on the heels of several other recent HPAPI expansion moves.\u00a0<\/p>\n Early last month, Swiss manufacturing powerhouse Lonza said it would throw down an undisclosed sum to bolster<\/a> HPAPI capacity and establish new commercial-scale ADC capabilities at its hub in Visp, Switzerland.\u00a0<\/p>\n