Business Insights, PHARMA TECH

Dalton Expands Commercial Sterile Manufacturing Capacity

Dalton Expands Commercial

On February 16, 2023, Dalton Pharma Services, a leading cGMP pharmaceutical firm, announced a significant strategic expansion of its sterile filling and pharmaceutical manufacturing capabilities. The capital expansion plan includes a brand-new, state-of-the-art, and fully automated cGMP sterile filling line that can fill syringes, vials and cartridges under isolator technology. The sterile fill line is integrated with a new cGMP lyophilizer to provide customers with complete sterile finished dosage form manufacturing capabilities.

In compliance with cGMP aseptic filling regulations, the newly launched sterile filling line supports small-scale commercial production to cater to the global market. Additionally, the capital expansion plan comprises further cGMP non-sterile powder filling capacity, enhanced multi-kilogram API manufacturing capabilities, and a better infrastructure for handling and storing organic solvents.

The company's capital expansion plan supports the goal of establishing it as a leading Contract Development and Manufacturing Organization (CDMO). As part of the Seikagaku Group, Dalton's long-term strategy is to provide pharmaceutical and biotechnology customers with high-quality integrated drug discovery, development, and manufacturing services through its North American facility.

Dalton Pharma Services CEO Peter Pekos commented, "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." He added, "It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities."

(Source – PR Newswire)

About Dalton Pharma Services

Founded in 1986, Dalton is a leading contract pharmaceutical manufacturer that offers integrated chemistry, development, and manufacturing services to biotechnology and pharmaceutical clients worldwide. The company operates from a 42,000 sq. ft. facility where they provide cGMP manufacturing of APIs, sterile injectables, finished drug products, and solid oral dosage forms. It has the capability to produce APIs in gram-to-kilogram quantities, including sterile APIs, and supports clients at any stage of the regulatory process. Dalton's development services include analytical method development, formulation, and polymorphism screening, among others. Additionally, the company offers over 2,500 reference standards, building blocks, metabolites, and impurities via its Dalton Research Molecules business to support the industry's pharmaceutical research programs.



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