The Delaware unit, which has provided consulting services since January, became fully operational yesterday offering aseptic contract manufacturing, laboratory analysis and engineering services for both clinical and commercial scale batches.
Isogen spokesman Robin Uhl told Outsourcing-pharma that the: “Science Center is unique from other pharmaceutical facilities [because it] offers state-of-the-art isolation and containment technology.”
“In addition, Isogen is not just a filling facility...[it] delivers engineering and analytical services with chemistry, microbiology and material sciences laboratories on site. That is why we call it the Science Center.”
He added that: “The Isogen Science Center was designed to handle most classes of therapeutics, including potent, cytotoxic compounds, monoclonal antibodies, vaccines or any products that require special handling.”
The site also houses an engineering unit to help pharmaceutical and biotechnology customers with everything from quality and regulatory documentation to facility and process development and equipment procurement services.
Filling capacity to double next year
Company CEO Les Edwards explained motivation for setting up the new facility and how it fits with Isogen’s approach to the clinical development market.
He told outsourcing-pharma that: “Through our consulting work, it became apparent that pharmaceutical companies had few good choices for manufacturing clinical trial supplies.
“My partner, Austin McDonald, and I launched Isogen to fill a very specific global pharma demand [for] affordable, high-quality filling that meets the unique needs of clinical and smaller commercial batches."
Edwards went on to explain that, unlike most manufacturing firms which provide commercial-scale production, Isogen is focused on delivering services that make small-scale production a reasonable business proposition.
He added that Isogen plans to double the science centre’s vials, syringe and specialty container filling capacity by the end of Q3 2010 to meet growing demand for these services, particularly for the rapidly expanding biopharmaceutical sector.