Press Room

Press Release / Jan 24, 2018

Hovione strengthens Inhalation Services portfolio

Hovione announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities

Continuous Manufacturing Drug Product Commercial Supply | Hovione

Loures, Portugal, January 24th, 2018 – Hovione announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities. This investment reinforces Hovione’s Services portfolio in inhalation product development capabilities, which include proprietary particle engineering technologies as well as formulation and capsule filling capacity to support from development to commercial scale projects.

Hovione’s new MG2 Tekna Precision Capsule filling unit complements our offering in encapsulation for inhalation products and has capacity for up to 110,000 capsules per hour with 100% net weight check and is fit to process highly potent compounds (down to 30 ng/m3). This unit complements the MG2 Flexalab and Mettler-Toledo Quantos encapsulation units that allows capsule filling for Phase I and Phase II clinical trials. In parallel Hovione has installed capacity in particle engineering suitable for inhalation, namely a multiple scale Spray Drying units for highly potent compounds, as well as a new wet polishing suite, and strengthened its analytical characterization toolbox.

From formulation composition, optimization and precision capsule filling with 100% fill weight check, to analytical characterization and scale-up to a commercial scale, Hovione can take product from the early proof of concept stages up to a fully developed and scaled process. Together with our API and particle engineering capabilities, we can fully develop and produce any Inhalation product at Hovione, from API synthesis to final drug product.

“We are excited to announce this new integrated offering, all at the same site where our scientists work together in the interface between particle engineering and final drug product for the benefit of an optimal product performance. This will allow us to support our customer’s inhalation projects at all scales and contribute to accelerate drug development and manufacturing timelines,” said Filipe Gaspar, Vice President R&D.   

“These investments are driven by significant client demand, since the market is looking for integrated inhalation product development solutions that reduce program risk and complexity. Hovione has all the ingredients for an outstanding partnership starting from clinical programs and into commercial supply.” Added Frédéric Kahn, Vice President Marketing and Sales.

Based on more than 20 years of experience in inhalation, Hovione can speed up your inhalation drug development, from a very early stage to a late development stage. Working with Hovione allows partners to take advantage of cutting edge particle engineering technologies and state of the art analytical facilities operated by highly skilled and responsive scientists.

 

About Hovione
Hovione has over 58 years of experience as a CDMO and is currently a fully integrated supplier offering for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.

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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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