- Grand River Aseptic Manufacturing (GRAM) is investing $100 million in a fifth GMP facility and sterile filling line to expand its fill-finish contract manufacturing capacity.
- The new line will support up to 50 million units annually of prefilled syringes and cartridges, with GMP readiness expected in Q1 2027.
Grand River Aseptic Manufacturing (GRAM) has announced a $100 million investment to expand its sterile fill-finish contract manufacturing capabilities in the United States. The investment includes a fifth Good Manufacturing Practice (GMP) facility and a new high-capacity sterile filling line designed to support growing demand for biologics delivered via prefilled syringes and cartridges.
The new filling line, a 10-head system equipped with an isolator, is designed to manufacture high-volume products while aligning with updated Annex 1 regulatory standards. It will have an annual capacity of 50 million units and will accommodate syringe sizes ranging from 1 mL to 10 mL and cartridge sizes from 1.5 mL to 20 mL. The system incorporates automated weight checks, stopper placement, and multiple filling mechanisms.
Installation of the new line is scheduled for the third quarter of 2026, with GMP readiness targeted for the first quarter of 2027. Factory Acceptance Testing for the equipment has already been completed. The line will be qualified using commercially approved products currently manufactured by the company.
The fifth GMP facility will span 150,000 square feet and include four filling bays, with additional space reserved for future expansion. It is located adjacent to GRAM’s 200,000-square-foot packaging and warehouse facility, which operates as a Foreign Trade Zone, supporting integrated manufacturing and logistics operations.
“The new filling line will be qualified with commercially approved products currently manufactured by GRAM, further underscoring the depth and trust in our client partnerships.”
Denis Johnson, CEO of GRAM
