Press Room

Press Release / Oct 19, 2015

Hovione acquires a Formulation Plant

Hovione announced today that it is investing in specialized formulation capabilities.

Loures, Portugal, October 19th, 2015 – Hovione announced today that it is investing in specialized formulation capabilities. The first step of the plan was the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

The facility will be engineered to enable to work with highly potent APIs and moisture sensitive compounds and will have dedicated rooms to allow for concurrent manufacture of these products. The facility will be capable to prepare a wide range of materials suitable for clinical trials as well as commercial batches meeting global regulatory requirements.

“Over the last decade we have built great knowledge in developing final dosage forms in the area of dry powder inhalation and oral dosage forms and have installed state-of-the-art formulation equipment to support these activities. Adding to our drug substance and particle engineering capabilities this new plant expands our integrated offer and technological capabilities to provide the best service to our customers”, said Filipe Gaspar, Hovione’s Vice-President R&D. “

“With this investment we will be able to expand our offerings and provide our clients with new services. I am sure our customers will value the option of not having to ship the material that comes out of our reactors and spray dryers to outside the walls of our site and away from our trusted quality culture.  This is also a great way to speed up the entire CMC development to meet the needs of the growing number of accelerated programs that our clients ask us to deliver on”, said Guy Villax, Hovione’s Chief Executive.

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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

 

 

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net    

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