- Alcami Corporation has achieved GMP readiness for a third sterile fill-finish line at its Research Triangle Park, North Carolina campus, bringing its total to five GMP-qualified lines across its drug product network.
- The new automated isolator line supports a range of vial formats and liquid and lyophilised products for clinical and commercial manufacturing.
Alcami Corporation has announced the GMP readiness of a third sterile fill-finish line at its Research Triangle Park (RTP), North Carolina campus. The addition brings the company’s total to five sterile fill-finish lines qualified for GMP clinical and commercial manufacturing across its drug product manufacturing network, supporting its activities as a CDMO providing contract manufacturing services.
The newly qualified line includes an automated Grade A isolator fill line designed for filling, stoppering and capping under aseptic conditions. According to the company, the line supports vial formats ranging from 2R to 30R and is equipped to handle both liquid and lyophilised products.
Alcami said the expanded capacity is intended to support client programmes from early-stage clinical development through to commercial production, including small and large molecule products manufactured in vials and pre-filled syringes. The RTP site forms part of Alcami’s broader drug product manufacturing capabilities.
“Our expansion reflects Alcami’s ongoing commitment to providing manufacturing solutions that accelerate drug development and ensure reliable supply.”
Guy Kubi, Chief Business Officer at Alcami
The company added that the new line aligns with its strategy to provide integrated, US-based manufacturing solutions and complements recent investments across its network. These include additional sterile fill-finish lines, expanded GMP and cold storage capacity, and enhancements to oral solid dose manufacturing.
