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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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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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