Alcami Corporation, a contract development and manufacturing organization (CDMO), unveiled that its third sterile fill-finish line housed on its Research Triangle Park, NC campus is officially good manufacturing practice (GMP) ready for both clinical and commercial manufacturing.¹

This marks the company’s fifth sterile fill-finish line that has qualified for GMP within its drug product manufacturing network. The most recent features an automated grade A isolator fill line with the capability of providing filling, stoppering, and capping under aseptic conditions. More importantly, it highlights the CDMO’s high interest in sterile manufacturing with quality and scalability in mind.

New line capabilities

Supporting vial formats from 2R to 30R—and both liquid and lyophilized products—the new line grows Alcami’s capabilities from early clinical development to commercial-scale manufacturing in vials, and prefilled syringes for small and large molecules.

"Our expansion reflects Alcami's ongoing commitment to providing manufacturing solutions that accelerate drug development and ensure reliable supply," said Guy Kubi, chief business officer. "We're delivering the precision and compliance our clients expect—while expanding capacity to meet the growing global demand."

This new development is consistent with the company’s interest in offering solutions that are able to help diminish supply chain risks, while also simplifying the journey from development to delivery.

Cambrex invests $120 million to scale US API manufacturing

In other CDMO news, Cambrex, a contract development and manufacturing organization (CDMO) that offers drug substance, drug product, and analytical services across the entire drug lifecycle, is financially committing $120 million to grow its US operations, particularly to address the demand for active pharmaceutical ingredient (API) development and production services.²

The latest investment will provide a 40% boost to the CDMO’s Charles City, IA site’s manufacturing capacity, which is currently close to reaching nearly one million liters. This plant produces various APIs and pharmaceutical intermediates, which feature controlled substances, along with highly potent molecules.

"Our customers, in partnership with federal and state agencies, are reshoring drug manufacturing in the US, the world's largest pharmaceutical market,” said Thomas Loewald, CEO of Cambrex. “Local API production is vital for supply chain security and resilience, and Cambrex will play a key role. We are seeing very strong demand from our customers to partner with Cambrex to utilize this expanded capacity.

"With rising demand for US-based supply chains for critical therapies, Cambrex is focused on supporting the long-term stability of pharmaceutical manufacturing in the United States. The investment in our Charles City facility, the nation's largest independent API manufacturing site, reflects our commitment to meeting clients' evolving needs for small molecule and peptide manufacturing."

The announcement builds on the momentum garnered by previous investments surrounding Cambrex's drug development and manufacturing services, including the completion of its $38 million capacity expansion at its small molecule API manufacturing facility in High Point, NC back in October 2023.² The expansion doubled the facility's manufacturing capacity, with new state-of-the-art analytical and chemical development laboratories, two new clinical manufacturing suites, and a small-scale commercial manufacturing operation with three work centers and 2,000-liter reactors.

References

1. Alcami Expands Drug Product Manufacturing Capacity to Meet Growing Demand. PR Newswire. December 16, 2025. Accessed December 18, 2025. https://www.prnewswire.com/news-releases/alcami-expands-drug-product-manufacturing-capacity-to-meet-growing-demand-302643577.html

2. Saraceno N. Cambrex Commits $120 Million to Grow US API Manufacturing. Pharmaceutical Commerce. October 24, 2025. Accessed December 18, 2025. https://www.pharmaceuticalcommerce.com/view/cambrex-commits-120-million-to-grow-api-manufacturing