The capital expansion plan includes a new state-of-the-art, fully automated cGMP sterile filling line with the flexibility to fill vials, syringes, and cartridges under isolator technology. The sterile fill line is fully integrated with a new cGMP lyophilizer, providing complete sterile finished dosage form manufacturing capabilities for customers.

The new sterile filling line meets cGMP aseptic filling regulatory requirements and is designed to support small-scale commercial manufacturing for global markets. The capital expansion plan also includes:

• Additional cGMP non-sterile powder filling capacity
• Expanded multi-kilogram API manufacturing capabilities
• Greater organic solvent handling and storage infrastructure

"This major investment in the expansion of our sterile manufacturing capabilities enables us to meet the needs of our customers as their critical products advance to commercialization," noted Peter Pekos, CEO of Dalton Pharma Services. "It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities."

The capital expansion plan supports Dalton's long-term strategy, as part of the Seikagaku Group, to be a leading CDMO providing high-quality integrated drug discovery, development, and manufacturing services to pharmaceutical and biotechnology customers from its North American facility.