Opening of the two advanced manufacturing facility expansions strengthens the CDMO’s capabilities in large-scale commercial small molecule API production and HPAPI manufacture.
US-based CDMO SK pharmteco has opened two advanced manufacturing facility expansions at its campus in Swords, Ireland. The investment adds capability for both large-scale commercial small molecules and ultra-high-potency active pharmaceutical ingredients (HPAPIs).
Declan Hannigan, Site Head & General Manager, Small Molecule Europe, SK pharmteco, said: “These two facilities will expand our capacity to safely handle HPAPIs and scale critical therapies from clinical development through global commercial supply.”
“These two facilities will expand our capacity to safely handle HPAPIs and scale critical therapies from clinical development through global commercial supply”
Declan Hannigan, Site Head & General Manager, Small Molecule Europe, SK pharmteco
Specifically, the expansion adds ~26.5 m3 of reactor capacity to its multi-purpose GMP small-molecule API facility. The site supports both future containment and capacity expansion.
Secondly, the CDMO has invested in the design of its kilo-scale GMP HPAPI & ADC payload facility. This supports manufacture of ultra-high potency compounds with occupational exposure limits (OELs) as low as 10 ng/m3.
The site is suited to batch sizes up to 0.5 - 1.5 kg, according to SK pharmteco. This includes glass reactor capacity up to 30 L, rigid and flexible isolators, high-pressure chromatography, tray drying, and lyophilisation.
Ultimately, this second facility “provides greater continuity as potent programmes transition from clinical development into full GMP production”.
Increasing capacity for both bulk commercial infrastructure and high-containment kilo-scale suites on the same site enables SK pharmteco’s partners to manufacture complex small molecules and targeted therapies.
In July, Lonza—another CDMO—expanded its HPAPI manufacturing capacity, investing in its facility in Visp, Switzerland.
Christian Seufert, Head of Advanced Synthesis, Lonza, said at the time: “The rapid growth of the ADC market is driving increasing demand for highly complex payload-linkers that require advanced manufacturing capabilities”, particularly for customised synthesis and advanced purification technologies.
Big pharmaceutical company Novo Nordisk in March added capacity to its manufacturing facility in Ireland, through a near €500 million investment for production of its oral GLP-1 medicines.
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