Press Room

Article / May 31, 2010

Handling potent drug materials

Cleanroom Technology, May 2010

Drug manufacturer Hovione has opened a new spray drying facility in Loures, Portugal, for potent active ingredients.

Marco Marques, head of production, describes the safety protocols.

Pharmaceutical contract manufacturer Hovione has recently received a significant number of new spray drying projects with special containment requirements. The company’s answer to this market demand has been to install a new spray dryer unit in a dedicated manufacturing suite at its site in Loures, Portugal. The facility design allows the handling of potent compounds up to class III, according to independent health & safety consultant SafeBridge, and it complies fully with good manufacturing practices (GMP) as required by international drug authorisation bodies.

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With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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