Sharp Scales Global Injectable Device Capacity for Clinical and Commercial

In Pennsylvania, the Macungie facility is set to launch a low-speed assembly line by early 2027, followed by a higher-capacity 50-unit-per-minute line by 2028. To accommodate temperature-sensitive biologics, the site added 4,400 pallet locations in cold storage, scheduled for occupancy by the end of 2026. Simultaneously, the Bethlehem location is installing a specialized low-speed line for rare disease and orphan drug programs, operational by the first quarter of 2027, alongside expanded cold room capacity for both 2-8°C and -20°C requirements.

European operations in Belgium are seeing parallel upgrades, including new assembly equipment capable of speeds up to 100 devices per minute. These lines will integrate functional testing alongside a fully automated cold storage warehouse. Jeff Benedict, Sharp’s Chief Commercial Officer, emphasized that these investments offer clients the necessary flexibility to scale programs at any product lifecycle stage, whether through Sharp-owned production lines or the integration of client-specific equipment.