Grand River Aseptic Manufacturing invests $100M in sterile fill-finish capacity

Grand River Aseptic Manufacturing (GRAM), a U.S.-based contract development and manufacturing organization (CDMO) specializing in sterile fill-finish services, announced a $100 million investment to expand its sterile injectable manufacturing capacity.

The investment includes a fifth sterile filling line and a fifth GMP facility designed to support high-volume commercial production of prefilled syringes and cartridges. The CDMO said the expansion is intended to address growing demand for patient-friendly biologic drug delivery formats.

The new filling line is a 10-head system equipped with an isolator and designed to meet Annex 1 requirements for sterile manufacturing. According to GRAM, the line has a capacity of up to 50 million units annually and supports a range of syringe and cartridge sizes. It incorporates automated weight checks, stopper placement, and multiple filling technologies to support process flexibility and control.

Factory acceptance testing has been completed, with installation planned for the third quarter of 2026 and GMP readiness targeted for the first quarter of 2027, the company said.

The new 150,000-square-foot GMP facility includes four filling bays, with additional space reserved for future expansion and redundant manufacturing capacity. According to the announcement, the site is located adjacent to the CDMO’s packaging and warehouse facility, which operates as a Foreign Trade Zone to support distribution and supply chain operations.