#USA #Durham #Alcami Corporation #Drug Manufacturing #sterile fill-finish line

Alcami Enhances Drug Product Manufacturing Capabilities

Alcami Corporation, a prominent contract development and manufacturing organization (CDMO) based in the United States, has made a significant stride in enhancing its drug product manufacturing capabilities. The company recently announced the Good Manufacturing Practice (GMP) readiness of its third sterile fill-finish line at the Research Triangle Park, North Carolina campus. This addition marks Alcami's fifth sterile fill-finish line qualified for GMP clinical and commercial manufacturing, showcasing the company’s dedication to expanding its capacity amid a rapidly evolving market.

The new fill-finish line is equipped with an automated Grade A isolator fill line, which is designed to ensure the safe and sterile filling, stoppering, and capping of vials under aseptic conditions. This advancement not only reinforces Alcami's commitment to high standards of quality and precision but also marks a pivotal moment in its strategy to innovate within sterile manufacturing.

The introduction of the new line comes with an impressive range of capabilities, supporting vial formats from 2R to 30R. This technology is adept at handling both liquid and lyophilized products, enabling Alcami to cater to the diverse requirements of its clients. The expansion empowers the company to deliver essential manufacturing support for a variety of programs, from early-stage clinical development through to full-scale commercial production of drugs in both vials and pre-filled syringes, thus accommodating the increasing demand for both small and large molecule pharmaceuticals.

Chief Business Officer Guy Kubi expressed the significance of this expansion, stating, "Our expansion reflects Alcami's ongoing commitment to providing manufacturing solutions that accelerate drug development and ensure reliable supply. We're delivering the precision and compliance our clients expect—while expanding capacity to meet the growing global demand."

With an experienced workforce that brings decades of expertise across analytical development, formulation, drug product manufacturing, and GMP storage, Alcami's commitment to quality is evident in every aspect of its operations. The latest line addition aligns perfectly with Alcami's broader strategy to provide integrated, onshore solutions that minimize supply chain risks and streamline the development-to-delivery process.

As the pharmaceutical landscape faces increased capacity constraints alongside growing global demand for sterile fill-finish services, Alcami's investments in infrastructure and technology assure clients access to state-of-the-art, Annex 1 compliant systems and reliable manufacturing solutions based in the United States. This expansion is part of Alcami’s comprehensive growth strategy, which has seen substantial recent investments including five new sterile fill-finish lines, a new GMP storage facility, increased cold storage capacity, and enhanced oral solid dosage capabilities.

For more information about Alcami’s extensive drug product manufacturing services, potential partners and clients are encouraged to visit the company’s website at www.alcami.com.

About Alcami Corporation

Alcami is a U.S.-based CDMO that has been at the forefront of pharmaceutical and biologic development for over 45 years. The organization prides itself on providing fully integrated lab services, drug product manufacturing, and cGMP pharmaceutical storage, backed by private equity partnerships with GHO Capital, The Vistria Group, and Ampersand Capital Partners. More details can be found on their official website.