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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A mechanical engineering graduate, this Frenchman is the CEO of the Portuguese pharmaceutical contract manufacturer Hovione. Still owned by the founding family, the company was awarded the 2025 ‘Léonardo de Vinci’ Prize, which recognizes the innovative and successful succession planning of family businesses. With an international career behind him, Jean-Luc Herbeaux is almost more fluent in English than in his native language. At 58, this Frenchman with iceberg-blue eyes is the CEO of Hovione. Founded in the late 1950s, this Portuguese group, with 100% family ownership, has just received the ‘Léonardo de Vinci’ Prize, which highlights entrepreneurial successes tinged with family legacy. While this mid-sized company with a turnover of €500 million maintains a low profile, its pharmaceutical contract manufacturing business is just as obscure to the general public. "Yet, the market for contract manufacturers, or 'contract development manufacturing organizations,' is worth $200 billion", emphasizes the CEO, who has been working in this microcosm for two decades. 500 patents Aware of the stakes, he does not deny "the pharma industry's dependence on Indian and Chinese capabilities". "The fact remains that the trend is toward the regionalization of supply chains, with European manufacturers producing for the Old Continent, American manufacturers for their own market, and so on", he says. And to highlight the foresight of Diane and Ivan Villax, the founding couple, "who thought globally from the very beginning". As a result, the group, with its 500 patents, has factories in China, the United States, and Ireland, without neglecting its home territory. This is evident by the site currently under construction on the banks of the Tagus River, following a €200 million investment. "The heavy engineering and compliance aspects are being finalized, "he explains, emphasizing that this highly regulated sector "is under a microscope". He knows this all too well, as Hovione claims to be involved in 5 to 10% of the drugs approved each year by the FDA, the American drug regulatory agency. Professor from Houston to Japan “In this small world, having a good image is important: this is the case with Jean-Luc, passionate about his work, but who knows how to demystify things”, observes Elie Vannier, former chairman of the board of Hovione. He adds that having an international profile is a strength “in this ecosystem where talent and clients are international”. For his part, Jean-Luc retains from his numerous flights “a taste for films of all genres and from all countries”. The son of an administrative employee in secondary schools and an auto insurance expert, the youngest of three children moved around according to his parents' job transfers. He was born in Meaux, grew up in Chartres, and attended the University of Technology of Compiègne, “which already offered programs abroad”. Thus, he left a mechanical engineering internship at a Dior perfume factory to join the University of Houston in Texas, "carrying a 20 kg backpack". Despite his then-limited command of English, he earned a doctorate, became a professor, and met an American woman who would become his wife and the mother of their two children. Next came the University of Kanazawa in Japan. Alas! Disappointed by the academic world, "where you have to fight to get resources", he succumbed to the allure of industry and joined the American chemical company Rohm and Haas, which had fallen under the control of the German company Evonik. 80 million patients He spent twenty years there, in Germany and Singapore, before "accepting the offers from headhunters". He then accepted Hovione's offer, who appointed him Chief Operating Officer in 2020, then CEO two years later, making him the first CEO not from the founding family. The family remains the sole shareholder, which earned the company the ‘Léonardo de Vinci’ Prize, created by the Association Les Hénokiens and the Clos Lucé. Having settled near Lisbon, he substituted walking for combat sports, "having been burned by the injuries of some friends". He also mentioned that Hovione, whose clients include 19 of the world's 20 largest pharmaceutical companies, helps treat more than 80 million patients.   (Translated version)   Read the original and full article in French on LesEchos.fr  

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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