Press Room

Nuno Matos speaker at the PAT & Quality by Design

Start
Tuesday, March 24, 2015 - 00:00
End
Tuesday, March 24, 2015 - 00:00
Location: London, UK

Nuno Matos
PAT Specialist

24 March 2015 - 2:10 PM
Quality by Design Principles in the Development of Chemical Processes to Manufacture Drug Substances

  • QbD approach at Hovione: managing risk and knowledge
  • How risk assessment, design of experiments, PAT and modelling are used to enhance process understanding and development
  • Overall benefits of a QbD approach applied to process development

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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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