Denis Johnson, CEO, Grand River Aseptic Manufacturing (GRAM), a CDMO of injectables, is expanding its capabilities in response to increasing demand for sterile manufacturing in the US. As part of its strategic growth, GRAM is making investments to expand its sterile injectable fil–finish capacity for syringes and cartridges. Johnson highlighted the company’s expansion at the DCAT Member Company Announcement Forum, held March 23, 2026, at DCAT Week.

GRAM’s latest initiative involves a $90-million investment in a new GMP facility in Grand Rapids, Michigan. The new facility spans 150,000 square feet and will feature four drug product filling bays, expanding the company’s overall production capabilities and capacity. The new site is adjacent to an existing 200,000-square-foot packaging and warehouse facility that has been approved as a Foreign Trade Zone.

To support this expansion, GRAM plans to increase its workforce to 1,000 employees. The first sterile filling line in the new facility is outfitted with technological advancements designed for both prefilled syringes and cartridges. GRAM’s new Groninger 10-head fill line is equipped with a SKAN Isolator that adheres to Annex 1 and the latest compliance standards. The line features key quality control aspects, such as 100% weight checks and stopper placement, ensuring the integrity and reliability of the products being manufactured.

The new fill line’s capacity is targeted for 100 million units per year. The facility will accommodate a range of syringe sizes from 1 mL to 10 mL and cartridges in capacities of 1.5 mL, 3 mL, 5 mL, 10 mL, and 20 mL. The configuration and capabilities of the new line include 100% vacuum stoppering as well as the use of peristaltic and rotary piston technologies. Advanced packaging solutions will also be in place, utilizing systems from Korber for automated inspection and Optima for labelling.

The new facility expected to be commercially operational by the first quarter of 2027. As of now, the building is complete, and occupancy permits have been secured. The first batch of team members has already transitioned to the new facility, and construction on the first fill suite is progressing and remains on schedule. Key milestones have already been achieved: the isolator has completed Factory Acceptance Testing (FAT), and the filling line is on track to undergo FAT in April 2026. The installation of the filling line is projected for the third quarter of 2026, with GMP readiness targeted for early 2027.