Dalton Announces Major Expansion in Commercial Sterile Manufacturing Capacity

USA - English

• USA - English

TORONTO, Feb. 16, 2023 /PRNewswire/ -- Dalton Pharma Services today announced a major strategic expansion of its sterile filling and pharmaceutical manufacturing capacity. 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.

About Dalton Pharma Services

Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development, and manufacturing services. Dalton is U.S. FDA-inspected, Health Canada-approved and brings over 35 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility, and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing, dosage form manufacturing, and ICH Stability Testing) all at one location help us to be adaptable, flexible and cost-effective. To learn more about Dalton's capabilities, please visit http://www.dalton.com.

About Seikagaku Group Corporation:

For over 70 years, SKK has been a leading R&D oriented pharmaceutical company pioneering the commercialization of glycoscience. SKK is committed to developing the extensive potential of glycoscience and using drug discovery, has created a wide range of novel and innovative pharmaceuticals and medical devices. At Seikagaku Corporation, we contribute to the health and well-being of patients around the world to achieve a prosperous future.

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