Cambrex expands high potency API capabilities
- Cambrex has completed its pilot plant expansion at its High Point, North Carolina facility by installing and commissioning a fourth reactor suite, expanding the site's capacity by around 30%. The site also has upgraded its analytical chromatography data systems for R&D and quality control, and has completed the construction and validation of an 11,000-square-foot analytical laboratory.
- The new suite, which will include two 2,000 liter glass-lined reactors and a 0.6 square meter filter dryer, will allow the manufacture of batch sizes of 10 kg to 100 kg under current Good Manufacturing Practice conditions for clinical trials.
- The company has also begun construction of a new $24 million facility at Charles City, Iowa, for the manufacture of highly potent active pharmaceutical ingredients, which could be on line as soon as the first half of 2019.
Highly potent active pharmaceutical ingredients (HPAPIs) are a fast growing part of the pharmaceutical industry, as they play an important role in targeted therapeutics that deliver a small amount of a highly toxic agent to where it is needed, for example a tumor. Their handling requires specialist equipment and highly trained personnel, as well as facilities designed to meet these specific needs. Cambrex has already outfitted a new facility in Milan, Italy with equipment focused on HPAPIs, and its Charles City, Iowa plant will add to its high potency capabilities.
The new plant, where the structural steelwork and foundations are now in place, will have a 4,500 sq. ft. production area that can operate down to an occupational exposure limit (OEL) down to 0.1 mcg/sq. m. It will have a total reactor capacity of 2,200 gallons, with vessels from 200 to 1,000 gallons, able to manufacture batches from 50 to 300 kg.
The plant's existing small-scale manufacturing area will be reconfigured to create a single high containment building to support early stage development and manufacturing, and will be flexible on scale.
"Both of these U.S. investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services," commented Shawn Cavanagh, COO of Cambrex in a statement. "We will continue to strategically invest across our global network of sites at all scales, from clinical through to commercial, to address customer demands and market requirements."
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