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Press Clipping / Nov 12, 2018

How Hovione grew from a basement lab to a global pharmaceutical services company

C&EN, November 12, 2018

Global Pharmaceutical Services Diane Villax Guy Villax | Hovione

Diane Villax poses in 1962 with her husband, Ivan (left), and this year with her son, Guy, in front of the house, Guy’s current home, where she and Ivan launched Hovione in 1959.

 

 

Diane Villax, Hovione’s still-active matriarch, recounts the rise of the pioneering firm

He started, the poor chap, at the age of 23,” recalls Diane Villax of her son Guy’s debut in 1984 at Hovione, the family’s pharmaceutical chemical business. “He was thrown to the lions in the Far East. To China. He was told by his father, ‘Build me a factory in Macau. Get me some land, talk to the authorities, and build me a factory.”

This he did, she says. “He built it in 14 months, ran it for six months, and asked for an FDA inspection.”

Still marveling at the audacity of the project, Diane recounts the many roadblocks to building a factory in Macau, a former Portuguese colony, now a Las Vegas-like gaming resort, where no construction engineers were up to the project in 1984. Shipping construction materials, glass-lined tanks, and other apparatuses from Italy, Greece, and the company’s home base of Lisbon was another daunting challenge, given that the only suitable cargo port was in Rotterdam, the Netherlands.

Her daughter, Sofia, was also deployed to China, in charge of quality control at the new plant. Diane remembers Sofia calling home rattled after an interview with an inspector who brusquely dismissed the upstart plant’s chances of passing a U.S. Food & Drug Administration audit. “Poor child,” she says. “Well, they had the inspection, and it was fine, so then they all celebrated.”

Over a Saturday lunch of boiled prawns and salad on the patio of her home in a Lisbon suburb, Diane shares several other anecdotes of how she and her husband, the chemist Ivan Villax, started a company in their basement, developing fermentation processes for the manufacture of antibiotics. It has evolved over 59 years to become a major supplier of drug ingredients and associated services, with factories on three continents.

Ivan died in 2003, but at 83 Diane remains active with Hovione. She is a board member, having stepped down as chair only two years ago. Guy and Sofia are also on the board, along with four outside nonexecutive directors, including the current chair. Passing the chair to an outsider, Diane says, seemed like the thing to do now that the company has achieved a critical mass.

 

Born in Portugal but raised in England—her mother Portuguese, her father British—Diane Du Boulay met Ivan, a Hungarian chemist displaced by the Russian invasion after World War II, in 1956. Both their families had moved to Lisbon. Ivan came from France, where he studied microbiology, developing chemistry for penicillin, tetracycline, and other antibiotics in his spare time.

“I think he got his first patent in 1955,” Diane recalls. “He was enjoying life in Lisbon. A young man about town and a scientist and a bit of a magician at dinner parties. He was very much in demand.”

The two married and started the company with two partners, both of whom left shortly thereafter. Diane and Ivan began by selling antibiotics and other generic drugs, achieving their first big success selling betamethasone in Japan. They built a manufacturing plant on land his family owned outside Lisbon in Loures.

“Ivan was obviously the inventor, the producer, and the salesman,” she says. “Somebody had to look after the back office, issue invoices, talk to the banks, and get some money. So that was me. For 35 years, nobody signed a check except for me. I was in charge of all the imports and exports and all the licenses.”

The focus remained on generics, Diane says, until Guy came back from an InformEx exposition in the U.S. in 1993, enthusiastic about exclusive synthesis of active pharmaceutical ingredients (APIs). They got a call from Bristol-Myers Squibb shortly thereafter with a request to make an API, found a chemical engineer willing to take on the complicated chemistry, and never turned back.

Nor has Diane disengaged from oversight of the company’s business, which in one famous instance involved direct engagement with a chemical.

Early on, with Ivan on the road, Diane was awakened one night by a chemical smell in the house. She called an engineer who worked for the company, and the two identified a leaking vessel in the basement. They found an empty container. Preparing to transfer the contents of the vessel, Diane realized that someone would have to suck on the hose to get the liquid moving. The engineer demurred, noting that they had no idea what was leaking.

“I had to do it,” she says. “Somebody had to get it going.” The operation was a success, and Diane soon learned that the solvent was ethyl acetate. “My husband was rather horrified when he learned of this.”

Diane Villax was awarded Portugal’s Scientific Merit Medal at the opening of Science 2017, a science and technology meeting in Lisbon. The medal is given in recognition of contributions to the development of science and scientific culture in Portugal.

 

Read the article at C&EN online

 

 

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Developing drugs with poor water solubility remains a major challenge for pharmaceutical manufacturers, because solubility impacts bioavailability and effective drug delivery. The vast majority of small molecule drug candidates have low water solubility. For more than two decades, the most successful particle engineering technology to improve drug solubility and bioavailability has been spray drying with an amorphous solid dispersion (ASD) platform. Spray drying improves the solubility of oral drugs, inhalable particles, and excipients, and increases the stability of heat-sensitive drug products. Hovione, recognized globally for its industry-leading spray drying capabilities, has recently completed a $100 million investment cycle to enhance its operations in New Jersey. This initiative has successfully doubled Hovione’s spray-drying capacity in the US, strengthening its position in the industry. Hovione’s Expanded U.S. Site in East Windsor, NJ  The first phase of the expansion in East Windsor, NJ, delivers a new 31,000 square foot facility and houses two size-3 spray dryers (PSD-3). This additional capacity allows Hovione to meet increasing customer demand for ASD development and good manufacturing practice (GMP) commercial production. GMP operations are scheduled to commence in the second quarter of 2026.  Hovione has also acquired 15 acres of neighboring land, strategically positioning itself for future growth and evolving customer needs for U.S. manufacturing. The newly acquired greenfield site will provide future support for PSD-4–scale commercial production as well as continuous and batch tableting production. It will also be a hub for centralized logistics, enhanced quality control laboratories, and next-generation research and development facilities.  A Global CDMO with a Growing U.S. Footprint  Hovione has operated in New Jersey for more than two decades, establishing itself with a strong U.S. presence for the production of drug substances, intermediates, and finished drug products. A continued emphasis on an integrated service offering, including spray drying, supports delivering innovative medicines to patients more quickly.  The expansion of the East Windsor site addresses the rising demand for U.S. manufacturing and is an integral part of the company's ongoing global growth strategy, with facilities in Portugal, Ireland, and Macau. The company continues to bolster a cohesive network for drug development and commercial manufacturing unified by a corporate quality system and governance framework.  The integrated offering enhances development speed and eases technology transfers by unifying the team's technical skills, proprietary technologies, and digital platforms to efficiently produce drug substance to drug products at a single-site, through Hovione’s “one site, one partner” vision. Furthermore, Hovione’s strategic partnership model offers customers exclusive access to advanced technologies and resources while aiding in the optimization of their development programs and ensuring sustained value creation.  End-to-End Spray Drying and Particle Engineering: From Grams to Tons Hovione is a global leader in spray drying and particle engineering. Services included solubility enhancement and controlled-modified release via development and production of ASDs of both small and large molecules, supporting various modalities. ASD-HIPROS, Hovione’s proprietary spray drying screening platform, identifies optimal formulations that offer optimal performance and stability. By increasing production volume in the US, Hovione will meet customer demand for spray drying services:  Development services in the laboratory (1 g – 1 kg batches)  Pilot scale production (0.5 – 25 kg batches)  Small-scale production (5 – 200 kg batches)  Large-scale commercial manufacturing (50 – 300 kg batches) A Commitment to Sustainability  Hovione’s core values include a commitment to sustainability at all facilities. This commitment is reflected in a business strategy that focuses on improving the communities where the company operates. Hovione’s sustainability policy and strategy align with the UN Sustainable Development Goals and include adherence to science-based targets in line with the Paris Agreement to address climate change. Meeting these goals has required a dedication to process intensification and ensuring sustainability of manufacturing processes. This has been possible through strategic planning and commitments from senior management to ensure sustainability is addressed throughout the drug development life cycle.  Partner with a Technology-Leading CDMO for U.S. Manufacturing   As demand for poorly water-soluble drug formulations continues to rise in the U.S., expanding spray drying throughput is essential to meet the need for innovative therapeutics. With proven leadership in spray drying to manufacture ASDs, Hovione is able to support pharmaceutical companies by solving their solubility challenges efficiently and reliably.  Partnering with a CDMO that combines global leadership, advanced technologies, and the necessary manufacturing capacity in the U.S., drug developers can expedite time to market, ensure quality, and deliver innovative medicines to patients faster.  If your company is seeking access to the latest spray-drying capabilities, expanded U.S. manufacturing capacity, and an accelerated path to regulatory filing and commercialization, contact our team today.     

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Aim to accelerate drug development and production with new technologies. By: Charlie Sternberg Hovione, an international integrated pharmaceutical development and manufacturing organization, and Microinnova Engineering, a leader in continuous process intensification, have partnered to advance the development of multi-purpose, plug-and-play modular equipment for flow chemistry. The companies will work together to test Microinnova’s modular manufacturing equipment, which is designed to offer greater flexibility, easier scalability, enhanced efficiency, and sustainable practices in active ingredient production, in an industrial setting. Together, the companies aim to accelerate process development, facilitate a seamless transition from lab to large-scale manufacturing, and ultimately reduce the time to market for pharmaceutical customers. “This collaboration with Microinnova underscores Hovione’s commitment to innovation in pharmaceutical manufacturing, with flow chemistry playing an important role in our long-term drug substance strategy,” said Dr. Jean-Luc Herbeaux, CEO of Hovione. “This partnership will allow us to shape and validate emerging continuous manufacturing technologies, which can potentially accelerate drug development and production.” Dr. Dirk Kirschneck, Founder and Strategic Director at Microinnova, added, “This partnership reflects our shared vision to deliver modular manufacturing technologies that support pharmaceutical innovation and manufacturing excellence. We are proud to join forces with Hovione to showcase the capabilities of our next-generation modular equipment in a dynamic CDMO environment, demonstrating its versatility for multi-purpose manufacturing.”   Read the full article on ContractPharma.com  

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