Alcami installs GMP-ready sterile fill-finish line in North Carolina

Alcami Corp., a U.S.-based contract development and manufacturing organization (CDMO), said it has achieved GMP readiness for a third sterile fill-finish line at its Research Triangle Park, North Carolina campus, expanding sterile manufacturing capacity within its drug product network.

According to the company, the new line is the fifth sterile fill-finish line qualified for GMP clinical and commercial manufacturing across Alcami’s operations. The line features an automated Grade A isolator designed for aseptic filling, stoppering, capping, and supports vial formats ranging from 2R to 30R for both liquid and lyophilized products.

Alcami said the expansion strengthens its ability to support programs from early-stage clinical development through commercial-scale manufacturing, including small and large molecule products in vials and prefilled syringes.

The new line aligns with the company’s broader strategy to provide integrated, U.S.-based manufacturing services that reduce supply chain risk and support Annex 1–compliant sterile production. 

The investment builds on earlier 2025 developments including new sterile fill-finish lines, expanded GMP storage, increased cold storage capacity, enhancements to oral solid dose manufacturing, as well as expansions to its laboratory services facility.