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Press Release / Mar 10, 2016

Hovione and Vertex Partner in Continuous Manufacturing

Hovione today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals

East Windsor, New Jersey, March 10, 2016 – Hovione today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in Hovione’s New Jersey location, and Hovione expects the project to be complete by the end of 2017 to support the future manufacturing of Vertex’s approved medicines.

Continuous manufacturing represents an innovative shift from the traditional multi-step, multi-location batch production process, which can take up to four weeks or more to make commercial-ready medicines. With continuous manufacturing, raw materials used to produce oral medicines (tablets) are fed into a single, continuously running machine that includes real-time release testing and can create commercial-ready tablets in just one day. Continuous manufacturing is well suited for the production of precision medicines and those with breakthrough therapy designations where development timelines may be short and there are patients in urgent need of transformative new treatments.

“This agreement enables Hovione to be at the forefront of an important evolution toward the use of continuous manufacturing and positions us as a reliable and innovative source for the production of new medicines,” said Filipe Gaspar, VP R&D at Hovione. “Like Vertex, we view continuous manufacturing as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies to more rapidly bring new medicines to those who need them.”

“Hovione and Vertex have been strong collaborators for more than a decade and share a commitment to innovative science,” added Guy Villax, CEO of Hovione. “This agreement adds to a recently announced $24 million investment in our New Jersey facility. The entire expansion will double Hovione’s development and manufacturing capacity at that site.”

The new facility will include all facets of the continuous manufacturing process, including continuous blending, wet or dry granulation, fluid bed drying, tableting and coating operations. Spare capacity will be offered to third parties who are interested in manufacturing medicines through this process.

 

About Hovione
Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area Hovione is the only independent company offering a complete range of services.

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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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