Press Room

Press Release / Apr 12, 2004

Hovione launches new Particle Design technology and state-of-the-art Spray Drying facilities

Hovione is pleased to announce that it has installed a new state-of-the-art Spray Drying facility to address the latest technology in particle design.

Hovione is pleased to announce that it has installed a new state-of-the-art Spray Drying facility to address the latest technology in particle design. The unit, installed at Hovione's API manufacturing plant in Portugal, operates under the most stringent cGMP conditions both as a conventional spray dryer for very fine particles ( 5 - 10µ) and as a fluidized spray dryer for agglomerated, free-flowing dustless materials (100 - 400µ).

Supplied and designed by Niro A/S to the most advanced specifications, this multipurpose unit is capable of evaporating 35 to 90 Kg of water per hour and is equipped with two atomizer systems (a pressure nozzle and co-current two-fluid nozzle). The spray dryer is fit to deliver injectable grade APIs and is configured to be "cleaned-in-place", discharging into a classified clean-room.

The facility allows Hovione to produce dry solids in either powder, granulate or agglomerate form from liquid feedstocks such as solutions, emulsions and pumpable suspensions. This technology enables continuous production, at low-cost and with a high degree of precision over particle design; it allows control of particle size over a wide range of sizes ( 5 to 400µ), as well as control over bulk density and degree of crystallinity. When operating as a fluidized spray dryer, the unit produces free-flowing dustless materials, which are uniform and can be used directly in tableting.

The system meets the most stringent explosion-proof requirements and can therefore spray-dry out of most organic solvents in a safe and compliant environment. It uses nitrogen in a closed cycle as the drying gas thus enhancing its safety and economical production aspects.

The spray drying facility is the result of a close collaboration between Hovione and Niro; the supplier of the equipment has described the unit as one of the most flexible and versatile GMP compliant spray-dryers that they have ever built. Hovione will be presenting its new technology and facility at Biofine in Berlin, on May 5th and 6th, stand nr. E3.

In its programme to expand scientific know-how in advanced technologies, Hovione is actively developing expertise in other particle design techniques:

  • Supercritical Crystallization - this technology offers a trouble-free separation of the product from the solvent and the capability to control the size and form of the crystals. The principle is based on replacing a conventional solvent with a supercritical fluid, which may act as a solvent or as an anti-solvent. This technique may be used to produce very small particles with narrow size distribution.
     
  • Ultra Sound Assisted Crystallization- this technology uses ultrasound to influence crystallization behavior by promoting cavitations within the liquid media, which serve as nuclei for new crystals to form. Benefits can include improved crystal habit, purity and the ability to manipulate crystal-size distribution and powder flow characteristics. It also offers a useful and more controllable alternative to seeding.

Hovione is an international group dedicated to the process development and synthesis of APIs (active pharmaceutical ingredients) serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards.

Note: please be informed that we have photos of the spray dryer available, contact us.

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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

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Márcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing. The landscape of small molecule manufacturing is rapidly evolving, according to Márcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains. Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs. Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents. Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products. Watch the full video interview or read the transcript at PharmTech.com  

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Hovione’s historic site in Loures has been expanded to meet demand and is now operating at full capacity. This Lisbon-based flagship company has developed innovative production techniques to serve laboratories around the world On the outskirts of Loures, in the periphery of Lisbon, a maze of multicolored pipes covers the walls of the Hovione factory. This industrial site, where signs warn of an “explosive atmosphere,” houses the production of active pharmaceutical ingredients — the core business of this company with Portuguese origins generating annual revenues of more than half a billion euros. “The products that leave here are shipped to every continent,” explains Diane Villax, the family matriarch. At 91, her voice moves effortlessly between English, French, and Portuguese — a cosmopolitan streak inseparable from the history of Hovione and the Villax family, its founders. The epic began with an exile: that of Ivan Villax in 1948. With a toothbrush in one pocket and his chemistry degree in the other, the 23-year-old anti-communist fled his native Hungary with relatives hunted by the Soviet regime. After a stop in Clermont-Ferrand, he dropped anchor in Lisbon, where he met Diane, from a family of sugar industrialists. One year after their marriage, they co-founded Hovione in 1959 with two other Hungarian refugees. The early days were artisanal: the company’s laboratory was located in the basement of the family home. “One of my earliest childhood memories is of adults in white lab coats. I knew how to use a fire extinguisher at six!” smiles Peter Villax, son of Ivan and Diane, who worked for Hovione for more than thirty years. Very early on, the duo expanded internationally, notably into Japan. The 1980s were prosperous years: growth surged at 20% annually. Then transformation accelerated with the arrival of new technologies in the early 1990s. Today, “the time required to move from test tube to industrial scale has been reduced to a few weeks, compared with six months in the past,” notes Peter Villax. The American adventure Sixty-seven years after its creation, the company — now headquartered in Switzerland — employs 2,400 people. Through medicines incorporating its active ingredients, Hovione claims to treats around an estimated 80 million patients worldwide each year. The Loures site has been expanded, and production has spread to Ireland, the United States, and Macao. The cellar at 1 Travessa do Ferreiro, where the story began, is now a distant memory. Little known to the general public, Hovione is nevertheless a key link in the pharmaceutical value chain: it develops and manufactures molecules for 19 of the world’s 20 largest laboratories. Its expansion has been fueled by favorable market conditions. “Pharmaceutical manufacturers increasingly rely on outsourcing for the production of active ingredients,” notes Loïc Plantevin, a pharma specialist at Bain & Company. “Historically, major groups chose to allocate more capital to research than to manufacturing, while biotech companies — which now drive most of the market’s growth — are not designed to build factories.” Far from resting on its achievements, the company has transformed its offering. “While the founders initially focused on generic active ingredients, Hovione has evolved toward more complex molecules and formulations, produced within exclusive partnerships with its clients,” explains Jean-Luc Herbeaux, a French national and the company’s CEO since 2022. This shift reflects a deeper trend. “For several years now, active ingredients have become a more differentiated market and less sensitive to price,” adds Loïc Plantevin. “Competitiveness is now linked to know-how and advanced production technologies, which require substantial investment.” Hovione is the world champion of spray drying, a technology enabling the production of soluble powders. With the expansion of its New Jersey site, the company aims to double its U.S. capacity — a country that accounts for 60% of its sales. Despite Donald Trump’s attacks on the pharmaceutical sector, which he claims to have brought to heel by forcing price cuts, Hovione remains confident. “We are in the U.S. to grow, and that ambition goes beyond the momentum created by the American administration,” assures Jean-Luc Herbeaux. “Our customers there are asking us to help them produce in the United States over the long term.” Commitment to cutting-edge research and the search for talent are deeply rooted in the company’s DNA. “In his later years, my father collaborated with Nobel Prize–winning chemist Geoffrey Wilkinson. Together, they would go to the Hovione lab to run experiments — just ‘for fun,’ as they put it,” recalls Peter Villax. The group is the largest employer of PhD students in Portugal and has forged partnerships with several national universities. “In some ways, Hovione resembles a university,” he continues. “Despite the sensitive nature of our technologies, we publish many academic research papers.” In search of lost sovereignty To preserve cohesion, the Villax family adheres to strict governance. “Unlike many Portuguese family businesses, most members of the third generation do not work in the company,” notes Duarte Pitta Ferraz of consulting firm Ivens in Porto. “Several independent directors sit on the board. The family’s role is to define values and long-term vision, not to manage day-to-day operations.” This responsibility is fully embraced by Jean-Luc Herbeaux. Since joining the group in 2020 as chief operating officer, sales have doubled. “My priority was to refocus the group,” says the engineer, who previously worked for German chemical giant Evonik. “We developed spray drying, invested in a new tablet-manufacturing process, and increased production speed through a new model that allows our clients to access all our services at a single industrial site.” A member of the European Fine Chemicals Group (EFCG), Hovione is actively defending European pharmaceutical manufacturing — a sector under strain. According to a study by the French Union of Organic Chemical Synthesis Industries (Sicos), Europe’s share of global active ingredient production has fallen from 48% to 30% in ten years, to the benefit of India and China. The reasons include production cost gaps — raw materials, energy — as well as the burden of European administrative and regulatory procedures, explains Maggie Saykali, director at the EFCG. “If we start a price war with our Asian competitors, we will not win it,” she admits. “It is better to compete on quality, innovation, and sovereignty over our value chain.” It took the Covid-19 pandemic and severe shortages for Europe to awaken. Last March, the European Commission proposed legislation on critical medicines. But the race against time has already begun. “China is increasingly using pharmaceutical ingredients as a tool of geopolitical pressure,” warns Maggie Saykali. “It is urgent to preserve European players like Hovione, focused on process innovation — which allows medicines to be produced with higher quality and greater environmental responsibility.” With a new site under construction in Seixal, on the southern bank of the Tagus River, the Lisbon star has not finished shining in the orbit of the global pharmaceutical industry.   (This is a translation from the original article)   Read the original article on lexpress.fr  

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