Press Room

Press Release / Nov 11, 2021

Hovione invests $170 million in new capacity and capabilities

Hovione, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives

Jean-Luc and Guy Villax at CPhI Hovione's booth in Milan | Hovione the global leader in spray drying and particle engineering

Jean-Luc Herbeaux, COO, and Guy Villax, CEO at CPhI Worldwide, in Milan.

 

Milan, 10th November, 2021 – Hovione, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives. The company has been on an expansion track since 2016 in Portugal, Ireland and New Jersey with the aim of continuing to increase its capacity and capabilities to address customer needs.

 

The announcement of a $170 million investment in Hovione units in Portugal, Ireland, and New Jersey, leading to a global capacity increase of approximately 25%, was made at CPhI Worldwide, in Milan, by Guy Villax, CEO, and Jean-Luc Herbeaux, COO. 

 

These investments will be used to support growth in the company´s pharma custom development and manufacturing service business, fueled by strongly growing demand for Hovione´s integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. The expansion will go hand-in-hand with a build-up of Hovione´s global team with the creation of more than 300 new jobs globally. This strategy will allow the company to continue to address difficult-to-meet client needs while reinforcing its commitment to the Hovione values and standard of quality.

 

In the USA, Hovione will add a 2900m2 building next to its current facility in East Windsor, New Jersey, laying the foundations for a state-of-the-art Hovione Campus. The upcoming cycle of investment will bring additional commercial spray drying capacity online by 2023. Further investments will follow with the aim to solidify the company´s integrated offer: API - Particle - Drug Product in the region. This expansion will allow Hovione to accompany existing and new customers favoring US-based manufacturing through their development cycles all the way to commercial.

 

The capacity and capabilities of Hovione´s Cork site in the Republic of Ireland will also be upgraded to enable the production of Highly Potent Active Pharmaceutical Ingredients (HPAPI) and to facilitate onboarding of Drug Substance Manufacturing projects of all sizes. The investment will create an ecosystem in which large customer projects with unique technologies can find a home by connecting to the existing infrastructure and equipment. The site will also receive a new commercial size spray dryer to support the growing demand for particle engineering services. 

 

In Portugal, Hovione is ready to start operations of its most recent facility with an increase in chemical synthesis capacity for High Potency Active Pharmaceutical Ingredients (HPAPI). The building is also prepared to receive a new commercial spray dryer to respond to the future needs of the global drug market.

 

“Hovione is in it for life and what better way to manifest this than through expansion of our global capacity and capabilities. Our sustainable organic growth strategy will allow us to keep true to those values that have been guiding us for more than 60 years”, says Guy Villax, Chief Executive Officer.

 

“These investments reinforce our integrated specialized offer globally, providing our clients with a line of sight for their projects. Focus is placed on facilitating and speeding up the drug development cycle and launch, by providing API manufacturing, Particle Engineering and Tableting services in each site. Our strategy continues to be to grow organically via investments in our existing sites, which are designed for purpose. This reduces the complexity associated with the growth journey and allows us to focus our management attention on what counts most, i.e. guaranteeing that our clients go to market with quality, safe and effective medicines for their patients” says Jean-Luc Herbeaux, Hovione’s Chief Operation Officer.

 

About Hovione: Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services 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, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. In the inhalation area, Hovione is the only independent company offering a complete range of services. Hovione is a company with a culture based on innovation, quality and delivery. 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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Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance. PharmTech: Which department is responsible for evaluating GMP equipment and facilities? Basile (Hovione): The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance. Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency? Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience. Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance. What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities? Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly. Another mistake might be failing to consider design for maintainability during upgrades and not during the design phase. Adequate space and access to equipment, standardized tools, having the right pickups on equipment for condition-based maintenance [are important considerations]. I can't tell you how many times I've seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it. Failing to consider design for maintainability and not bringing maintenance in during the design phase is one mistake that people often make. Not carving out a role for a dedicated maintenance planner is also a misstep. 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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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