SK pharmteco, a Rancho Cordova, California-based contract development and manufacturing organization (CDMO), has completed two facility expansions at its Swords, Ireland manufacturing campus, adding commercial-scale small molecule active pharmaceutical ingredient (API) capacity and a kilo-scale facility for high-potency APIs (HPAPIs) and antibody-drug conjugate (ADC) payloads.

The multipurpose GMP small molecule API facility adds approximately 26.5 cubic meters of reactor capacity, including three 8,000-liter glass-lined batch reactors, associated holding capacity, and a 4.15-square-meter Hastelloy agitated filter dryer. According to the announcement, the new infrastructure was integrated into the existing manufacturing site and is designed to accommodate future containment and capacity expansions.

The new kilo-scale GMP HPAPI and ADC payload facility is designed to handle compounds with occupational exposure limits as low as 10 ng/m³. The facility supports batch sizes of 0.5 to 1.5 kilograms and includes glass reactors with capacity up to 30 liters, rigid and flexible isolators, high-pressure chromatography, as well as tray drying and lyophilization.

Located alongside the site’s existing ultra-high-potency laboratory and manufacturing facilities, the kilo-scale facility is designed to support the transition of potent compounds from clinical development into GMP production, according to the company.

The Swords expansion adds to SK pharmteco’s broader manufacturing capabilities for advanced therapies. In July, the company said its France-based subsidiary Yposkesi had produced 20 AAV8 micro-dystrophin manufacturing batches for Genethon’s investigational muscular dystrophy gene therapy, including 18 batches manufactured under cGMP conditions. SK pharmteco is producing additional clinical batches while preparing process validation and documentation to support potential commercial manufacturing.