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Press Clipping / Aug 01, 2017

CMOs Must Embrace Flexible Manufacturing

PharmTech, August 1, 2017

CMOs are embracing continuous manufacturing in several ways. Some (e.g., Patheon and Catalent) are investing directly in continuous lines that will be available to customers much like traditional lines. Other CMOs are collaborating with bio/pharma companies that have developed their own technology. In one widely reported example, Hovione is building a new suite at its East Windsor, NJ, site to house a continuous manufacturing line developed by Vertex Pharmaceuticals to produce its own products. Hovione will operate the line and will be able to sell any uncommitted capacity to third-party customers.

The Hovione-Vertex collaboration is an example of another way that CMOs are responding to the need for flexibility in manufacturing: developing new types of collaborations with clients. The traditional CMO business model, with multiple clients sharing the same tightly scheduled production trains, is not adaptive; it is basically a one-size-fits-all. CMOs must be more innovative in their sourcing arrangements (i.e., they must offer manufacturing arrangements that can adapt to the market response as the new product is rolled out).

 

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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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