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Article / Oct 10, 2022

Hovione’s Continuous Manufacturing Facility, Loures, Portugal

Pharmaceutical Technology, 10 October 2022

Hovione has expanded its continuous tableting capacity with a state-of-the-art manufacturing facility at its site in Loures, Portugal.

Portuguese pharmaceutical contract development and manufacturing company Hovione has built a state-of-the-art continuous tableting manufacturing facility at its existing site in Loures, Portugal, to expand its continuous manufacturing offering and services.

The company invested $70m to develop the facility, which is part of its broader $170m investment programme to increase its production capacity by around 25% by 2023. The investment will enable Hovione to develop differentiated and empowering capabilities and assets to meet customers’ specific requirements for manufacturing oral dosage forms.

The new drug manufacturing facility came online in September 2022.

 

Details of the pharmaceutical facility expansion

Hovione Loures was expanded with a manufacturing building and eight-lab quality control facility. The company also upgraded its labs with the tools required to support the drug product lifecycle to ensure competency and capacity through research and development (R&D) to the production stage. In addition, it established an experienced, multi-disciplinary global team in continuous tableting to further improve its capabilities.

Hovione has designed a commercial continuous tableting platform that facilitates key control requirements and offers operational ease, mechanistic modelling, and appropriate process analytical technology to its customers. The features of its quality system include automated in-process controls, real-time release deployment, and compliant digital infrastructure. These are designed to support the release of continuous tableting products.

The company’s technology offers features and benefits such as faster development of simpler processes, rapid manufacturing of variable demand, strong control strategies and high process quality standards.

 

Details of Hovione’s existing site in Loures

Hovione’s existing manufacturing plant at Loures has been operational since 1969 and has been continuously upgraded by adding new facilities. The plant was first approved by the US Food and Drug Administration (FDA) in 1982 and is inspected regularly.

The manufacturing plant supports the development, piloting and full commercialisation of drug substances and product intermediates. It has an extensive capacity of 430m³ of vessels, ranging from 50lt to 14,000lt, along with a complete range of spray dryers with sizes ranging from lab-scale to industrial sizes.

The site also features highly potent active pharmaceutical ingredient (API) handling, cryogenic, hydrogenation, corticosteroid, and potent spray-drying capabilities. It is staffed by highly skilled and experienced process development and analytical development teams that assist with the drug substance and particle engineering disciplines.

The plant and the quality control labs operate 24 hours a day, seven days a week.

The Loures site has been certified by the Health, Safety and Environment Management System in compliance with OHSAS18001 and ISO14001. It is also a certified Authorised Economic Operator.

 

Marketing commentary on Hovione

Established in 1959, Hovione is an integrated contract development and manufacturing company (CDMO) with more than 60 years of experience. It offers services for drug substances, drug product intermediates and drug products.

The company currently operates four FDA-inspected facilities in the US, China, Ireland and Portugal, as well as development laboratories in Lisbon, Portugal, and New Jersey, US.

The opening of Hovione’s first manufacturing plant in Loures, Portugal, in 1969 was followed by its second manufacturing site in Macau, China, in 1986. The company subsequently opened plants in New Jersey in 2001 and Cork, Ireland, in 2009.

Under the company’s $170m investment programme, Hovione is investing $50m in its manufacturing facility in East Windsor, New Jersey. This expansion will add two spray dryers to the facility and triple its capacity, as well as expand its capacity for research and small-scale API production. The company is investing a further $50m to add a spray dryer and upgrade its high-potency API production in Cork, Ireland, as part of the investment programme.

 

Read the full article at Pharmaceutical-Technology.com

 

 

 

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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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