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The podcast "The Next Discovery" is a six-episode series created by Observador, a leading Portuguese digital newspaper and radio station, in partnership with Hovione. From factory to pharmacy in far less time: how continuous tablet manufacturing is making treatments faster, more robust, and more accessible to those who need them most. What if some of the scientific breakthroughs that could improve the lives of millions of people were happening right now in Portugal? Welcome to The Next Discovery. Listen to the fourth episode of the podcast here, featuring João Ventura, Senior Director of Pharmaceutical Product Development at Hovione. [English transcription] Nelson Ferreira (NF): Welcome to The Next Discovery. This is a partnership between Rádio Observador and Hovione—a six-episode series in which we open the doors to global pharmaceutical development driven from Portugal. I’m Nelson Ferreira, and today we’ll explore a technology that is transforming the way medicines are produced and accelerating patient access to new treatments. To guide us on this journey, we’re joined by João Ventura, Senior Director of Pharmaceutical Product Development at Hovione. NF: Hello, João, and welcome. For decades, the industry relied on what is known as batch manufacturing. How did this traditional method work, and why does continuous manufacturing represent such a significant change for the pharmaceutical industry? João Ventura (JV): Thank you, Nelson, for the invitation and for that question, which is a great place to start discussing this innovation. As you mentioned, for many decades the pharmaceutical industry produced tablet medicines using the traditional batch manufacturing method. This approach involves producing a very specific quantity of product—a batch—at a time and performing each individual production step separately. This means that each subsequent step typically begins only after the entire batch from the previous stage has been manufactured, processed, collected, and sampled for quality verification. In tablet production, the process includes weighing, blending, granulation, tablet compression, and finally tablet coating. While this method is well understood, mature, and fully established from both an industrial and regulatory standpoint, it can become inefficient because material may spend a considerable amount of time sitting idle between production stages—waiting for quality checks or for equipment in the next step to become available. By contrast, continuous tablet manufacturing allows material to move continuously and automatically through all stages of the process while simultaneously monitoring the quality of the tablets being produced. This enables continuous manufacturing to deliver benefits that traditional batch manufacturing simply cannot achieve. NF: João, producing continuously certainly sounds more logical, but as I understand it, this is still a relatively new technology in the pharmaceutical industry. When did the market begin to embrace this change? JV: You're absolutely right, Nelson. As you know, the pharmaceutical industry is necessarily conservative and adopts innovation very carefully, for good reason. It was only in the early 2000s that the U.S. Food and Drug Administration (FDA) began encouraging the industry to develop alternative technologies that were both more agile and more robust from a quality perspective. These technologies are based on integrating and automating the entire tablet manufacturing process in a continuous flow. This required the development of a new generation of manufacturing equipment capable of performing the entire process automatically and continuously, as well as sophisticated electronics and software to monitor and inspect product quality throughout intermediate stages and in the final tablet. Following these early technological developments, the FDA approved the first continuously manufactured products from major pharmaceutical companies such as Vertex and Janssen during the 2010s. This marked a pivotal turning point and significantly accelerated adoption of continuous tablet manufacturing. NF: What practical challenges does this new system solve in day-to-day operations? I imagine there are important quality-control advantages as well, especially since you mentioned quality can be assessed throughout the process and in the final tablet. JV: Absolutely. The successful commercialization of that first wave of continuously manufactured medicines by companies such as Vertex and Janssen was extremely important because it demonstrated to the industry that this technology could deliver substantial benefits for both patients and manufacturers. First, it shortens development and production timelines for new medicines, allowing innovative therapies and new drug products to reach patients much faster than before. NF: So they can reach the market sooner as well. JV: Exactly. In addition, as you mentioned, this technology makes it possible to verify the quality of every tablet produced, rather than relying on a small sample as in batch manufacturing. That alone provides greater quality assurance and robustness, ultimately benefiting society as a whole. NF: And does that speed advantage become particularly important during medical or public health emergencies? Can this system respond more quickly to urgent demand? JV: Yes, that is one of the technology’s most significant potential advantages. In a continuous process, it’s possible to produce in minutes what might take weeks in traditional batch manufacturing due to processing delays and waiting times. Beyond the economic benefits, this offers a major advantage in medical or public health emergencies, where production of new medicines may need to be rapidly scaled up to meet urgent demand. NF: Was COVID-19 an example of that? JV: It’s a perfect example. NF: Has this technology already delivered that benefit? JV: Not yet, but we anticipate that in future pandemic situations, continuous manufacturing will play a critical role in scaling industrial production much more rapidly, much as we saw with the need to rapidly expand vaccine production. NF: Hovione positioned itself as a global pioneer in this technology, largely through a strategic partnership with Vertex that you mentioned earlier. This happened in 2016. How did a Portuguese company become the first of its kind to adopt such an important industrial-scale advancement in the United States? JV: Since its founding, Hovione’s history has been closely linked to the adoption and application of new pharmaceutical manufacturing technologies capable of delivering significant industrial and economic advantages. That has been one of the company’s keys to success. During the 2010s, Hovione recognized the potential and benefits of continuous tablet manufacturing early on. As you mentioned, in 2016, Hovione entered into a strategic partnership with Vertex to establish industrial-scale continuous tablet manufacturing capabilities in the United States. Hovione was likely the first company of its kind to adopt this technology. This was important not only for industry-wide adoption but also because, in partnership with Vertex, it played a key role in developing a new, more effective treatment for cystic fibrosis—a devastating, currently incurable disease that primarily affects children. NF: Earlier, you mentioned that this represented a significant industrial challenge. I imagine it required designing and installing far more sophisticated equipment to make it all work. JV: That's correct, Nelson. The challenges were enormous during the first industrial-scale implementation of continuous tablet manufacturing. Hovione’s team led the project from the initial facility and equipment design stages all the way through construction of the building, installation of the new equipment, and operational execution of the manufacturing process for this new Vertex medicine, which has played an important role in treating a serious and incurable disease. NF: After that first facility in the United States, this technology was also brought to Portugal, to Loures, where Hovione has operated a second production line for several years. Does this, in a way, complete the cycle for Hovione, allowing the company to work from molecule to finished tablet? JV: Exactly. Following the success of the first industrial installation and the experience gained, and driven by growing market demand and interest in the technology, Hovione expanded its manufacturing capacity in the early 2020s by building and commissioning a second continuous tablet manufacturing facility at its Loures site in Portugal. As you noted, the Loures facility is capable of performing the entire development cycle—from chemical production of the innovative molecule through formulation and manufacture of the final tablet. NF: João, we’re speaking at a time when global soccer competitions often inspire national pride. I imagine there’s also a sense of pride when patients anywhere in the world take an innovative medicine knowing that the engineering and technology behind it involved Portuguese teams. JV: Absolutely, Nelson. By combining our ability in Portugal to identify and adopt innovative technologies with investments in advanced manufacturing capabilities, we can position ourselves as trusted partners to our customers across our industries. That has certainly been the case with Hovione. As you mentioned, we have helped produce innovative medicines that improve the quality of life of millions of people around the world. That should be a source of pride for all of us here in Portugal, just as our national soccer team is. NF: João, thank you very much for explaining how this technology is challenging traditional manufacturing and accelerating the production of life-saving medicines. João Ventura is Senior Director of Pharmaceutical Product Development at Hovione. That concludes the fourth episode of The Next Discovery. In the coming weeks, we’ll explore a new topic: how the respiratory and nasal systems can be used to deliver medicines more effectively to the lungs and, in some cases, even serve as a direct highway to the brain. Don’t miss the upcoming episodes at observador.pt and on your favorite podcast platforms. Until the next discovery.

Article
Observador Lab, 9 July 2026

Podcast “The Next Discovery” (EP4) - Continuous Tablets, Lives in Motion

Jul 09, 2026

The podcast "The Next Discovery" is a six-episode series created by Observador, a leading Portuguese digital newspaper and radio station, in partnership with Hovione. From particle engineering to global leadership in spray drying, discover the technology that enables oral medicines to be effectively absorbed by the body and help treat millions of people. What if some of the scientific breakthroughs that could improve the lives of millions of people were happening right now in Portugal? Welcome to "The Next Discovery. Listen to the third episode of the podcast here, featuring Filipe Gaspar, VP Technology Intensification, and José Luís Santos, Strategic Business Management Senior Director, at Hovione. [English transcription] Nelson Ferreira (NF): Welcome to The Next Discovery. This is a partnership between Rádio Observador and Hovione, a six-episode series in which we show how science developed in Portugal has a real impact around the world. I’m Nelson Ferreira, and in the last episode we explored how APIs—the active pharmaceutical ingredients in medicines—are produced. Today, we move to the next stage: how do we transform that chemical powder into a medicine that our bodies can actually absorb? To help explain this science, I’m joined by Filipe Gaspar and José Luís Santos, who were involved in the creation and development of Hovione’s particle engineering division. Welcome to you both. Filipe, let me start with you. NF: When we hear about a new medicine, we usually think about the molecule that was discovered. But why isn’t that discovery alone enough? What exactly is particle engineering, and what role does it play in turning a promising molecule into a medicine that is truly effective? Filipe Gaspar (FG): Nelson, the active ingredients in many modern medicines are not effective in the form in which they are produced through chemical or biological processes. To work properly in the body, they need to undergo additional transformations. For example, some medicines must be protected from the acidity of the stomach so they can later be released in the intestine, where the environment is less acidic and absorption into the bloodstream can occur. Others require very specific particle sizes. This is the case with inhalation powders, often used to treat asthma or chronic bronchitis. If the particles are too large, they become trapped in the upper airways and never reach the alveoli, where they need to be absorbed. On the other hand, if they are too small, they may simply be exhaled before absorption occurs. Finding the right particle size is therefore essential to ensuring an effective treatment. Another remarkable example is modern oral medicines, which often need to be converted into a different form—the amorphous form—so that the body can absorb them properly. Particle engineering makes all of this possible, overcoming many of these limitations by improving drug absorption, distribution, and therapeutic effectiveness. NF: I believe that in 2003 Hovione made a bold decision and invested in spray drying technology. José, for our listeners, could you explain in simple terms what this technology is, what problem it solves, and why it was so revolutionary at the time? José Luís Santos (JLS): First, it’s worth noting that spray drying has been used for decades in other industries. Think, for example, about powdered milk, instant coffee, or the powdered detergent we use in our washing machines. In all these cases, we start with a liquid—milk, coffee, or a soap-based paste—and transform it into a very fine powder that dissolves almost instantly when mixed with water. This transformation is achieved through spray drying. To explain it simply, imagine a very large chamber, something like a giant hair dryer. Inside, the liquid we want to dry is converted into a spray—a kind of mist—creating extremely small droplets. These microscopic droplets are then dried very rapidly using hot gas inside that giant dryer. In just milliseconds, the liquid evaporates, leaving behind a powder made of tiny particles with properties that, as Filipe mentioned, make them highly soluble. The powders we produce in the pharmaceutical industry are physically similar to powdered milk, instant coffee, or powdered detergent. Now, why was this technology revolutionary for pharmaceuticals? Just as spray drying made it possible to preserve milk for months without refrigeration or gave us coffee that can be prepared in seconds, pharmaceutical spray drying made it possible to create medicines with improved therapeutic effectiveness because they became more soluble. Without access to spray drying technology, many of these medicines would simply not have had a viable path to reach the market and ultimately patients. NF: Filipe, we now have a better understanding of what happens in the factory, but I’m curious about what happens inside a patient’s body. Can you give us some concrete examples? What happens when a molecule looks promising in the laboratory, but the body cannot absorb it effectively? FG: Of course. As surprising as it may sound, most medicines taken orally—tablets and capsules—are actually less soluble in water than glass or marble. Since our gastric and intestinal fluids consist primarily of water, these medicines, in their original crystalline form, dissolve very poorly and can pass through the digestive system without being absorbed into the bloodstream. That would make them completely ineffective. Spray drying solves this problem by transforming them into an amorphous form that dissolves much more easily and can be absorbed by the body. A simple analogy would be to compare an ice cube with snow. Both are solid water, but snow melts much faster because of its structure. Spray drying applies a similar principle to medicines, significantly enhancing their ability to dissolve and be absorbed. NF: José Luís, some of this may sound very technical to our listeners, but the outcome is ultimately that people live longer and healthier lives because of these technologies. Are there concrete examples of medicines that only reached the market and patients because of this technology? JLS: Absolutely. One of the most significant examples involving Hovione was the COVID-19 treatment effort. Hovione participated in the production of Captisol, a compound that was essential in the manufacture of Remdesivir, Gilead’s antiviral medicine, which became one of the few treatments authorized for COVID-19. Another important example is the treatment of hepatitis C. Around 10 to 12 years ago, the disease was virtually eradicated in many parts of the world thanks to new medicines whose manufacturing processes relied on spray drying technology. This enabled those therapies to achieve the solubility and therapeutic effect required. These are just two examples. At Hovione—and across the industry—we are working with a growing number of medicines, including treatments for oncology, cystic fibrosis, and many other diseases that benefit from spray drying technology and the advantages it offers. NF: From what I understand, this technology will continue to play an important role in future discoveries as well. Filipe, when Hovione invested in spray drying, it was a technology that was almost inaccessible and rarely used in the pharmaceutical industry. What did Hovione see that others didn’t? And how did what seemed like a risky bet eventually position the company as a global leader in this field? FG: When we invested in the technology in 2003, we had already identified one or two opportunities. As you said, it was a technology that was practically nonexistent among companies like Hovione that provide services to the pharmaceutical industry. We decided to invest before there was established market demand, which meant taking a significant risk. We were talking about many millions of euros—the cost of an industrial-scale spray dryer. Afterward, we actively developed the market. The demand we saw, particularly the need to improve the bioavailability of oral medicines, confirmed our highest expectations. We have made—and continue to make—ongoing investments in science, technology, and industrial capacity. Over the years, these investments have consolidated Hovione’s position as a global reference in spray drying. Now, we must continue innovating to maintain that position. NF: Based on the examples we’ve been hearing, that doesn’t seem likely to be a problem for Hovione. We also know that innovation doesn’t happen in isolation. Spray drying appears to be another example of that. Hovione seems to have strong ties with academia and universities through master’s and doctoral programs conducted in industrial settings. Is this collaboration the secret to staying at the forefront? JLS: Yes. Our connection with academia has always been very important and continues to be so. Today, we have more than 300 people working in research and development roles, and we maintain strong ties with the academic community. Hovione is one of the largest private employers of PhDs in Portugal, with approximately 120 PhDs on staff, and we actively promote projects in partnership with universities and research centers. FG: I would also like to mention the Hovione Research Program. NF: What is that? FG: It is Hovione’s research program. It is a collaborative initiative with Portuguese academic institutions and has been active for more than 15 years. To give you an idea, at any given time we typically have around 10 PhD candidates and between 20 and 30 master’s students conducting their work in an industrial environment simultaneously. Most of these researchers end up joining Hovione after completing their studies, integrating into the same areas in which they carried out their research. They are a reflection of this collaboration with academia, which has been a key driver not only of our ability to innovate but also of our capacity to attract and retain highly qualified talent. NF: Filipe Gaspar and José Luís Santos, thank you both for showing us that behind every medicine there is an enormous amount of science, innovation, and talent. And often it is invisible technologies—such as the spray drying technology we discussed in greater detail today—that make a difference in the lives of millions of people. This concludes the third episode of The Next Discovery. Next week, we take the next step and discover how Hovione challenged industry tradition by introducing continuous tablet manufacturing. You can listen to the next episodes on observador.pt and on your usual podcast platform. See you at the next discovery.    

Article
Observador Lab, 2 julho 2026

Podcast “The Next Discovery” (EP3) - Particles that change lives

Jul 02, 2026

The podcast "The Next Discovery" is a six-episode series created by Observador, a leading Portuguese digital newspaper and radio station, in partnership with Hovione. From hard-to-produce antibiotics to innovative therapies, Hovione uses complex and sustainable chemistry to bring safe medicines to patients around the world. What if some of the scientific discoveries that could improve the lives of millions of people were happening right now in Portugal? “The Next Discovery.” Listen to the second episode of the podcast here, featuring Rui Loureiro, scientist at Hovione. [English transcription] From hard-to-produce antibiotics to innovative therapies, Hovione uses complex and sustainable chemistry to bring safe medicines to patients around the world. What if some of the scientific discoveries that could improve the lives of millions of people were happening right now in Portugal? “The Next Discovery.” Nelson Ferreira (NF): Welcome to the podcast “The Next Discovery.” This is a partnership between Rádio Observador and Hovione—a six-episode series where we open the doors of a Portuguese-founded multinational pharmaceutical company to share real stories of science, innovation, and global impact. I am Nelson Ferreira, and in the first episode we explored the story of the basement where it all began more than 65 years ago. Today, we will understand what happens inside this company. We will talk about complex chemistry, because that is where the journey of many medicines that pass through Hovione begins. We will discover how laboratory science becomes industrial processes, how sustainability is part of this transformation, and how all of this contributes to producing medicines that truly help improve and save lives. To guide us on this journey, I am joined today by Rui Loureiro, a scientist at Hovione’s Research and Development Center. Hello, Rui. Welcome to Rádio Observador. NF: Rui, most people may never have heard of Hovione, but they may be taking a medicine where Hovione played an important role. Where exactly do you fit into this long journey that takes a medicine to the patient? Rui Loureiro (RL): Hello, Nelson, good morning—and thank you for the question. The path for a medicine to reach a patient is long. It starts with producing a very small amount of a drug, which through development eventually needs to be produced in kilograms. Let me give an example. Imagine baking cookies. When you buy cookies at the supermarket, someone first made the initial batch at home—but then they needed a partner to scale those cookies to an industrial level. NF: A factory, exactly. RL: Exactly. That is where Hovione comes in. We are that partner for the pharmaceutical industry—helping turn one cookie into many cookies that eventually reach patients. NF: For those listening who are not familiar with this field, people often talk about APIs in the pharmaceutical industry. I had to look it up myself. What is it, and why has Hovione focused so much on it since early on? RL: API can mean different things depending on the field—for example, in IT it means something entirely different. In the pharmaceutical industry, API stands for Active Pharmaceutical Ingredient. In Portuguese, princípio ativo—the component that treats or cures the disease. Using the cookie analogy again: a chocolate cookie has many ingredients—but the chocolate is what defines it. The API is exactly that in a medicine: a small but essential part that delivers the therapeutic effect. Even though tablets contain multiple substances, producing something like a 10 mg tablet of the active ingredient alone is difficult—so other components are added to create the final form. NF: Over many years, Hovione also specialized in complex generics. How did that experience help you move into working with companies developing entirely new medicines? RL: That was a very important step. Developing complex generics means the chemistry required is challenging—it may involve very low temperatures or tightly controlled conditions to ensure we produce the desired result and not something unwanted. Those early capabilities—developing antibiotics and other materials—led the market to recognize Hovione’s expertise. Ultimately, chemistry involves combining building blocks. If someone proves they can assemble the most complex ones, the industry will take notice. That is how we became recognized as a trusted partner for complex pharmaceuticals. NF: I am curious about this idea of “complex chemistry.” You often compare chemistry to cooking—what distinguishes traditional chemistry from the complex chemistry you do at Hovione? RL: Let me simplify for clarity. Complex chemistry depends on the reagents and solvents used. The starting materials may be difficult to transform and may require very specific conditions. The resulting product may also be unstable and require careful handling. Using cooking as an analogy: simple chemistry is like making jelly—you mix powder with hot water and let it set. Complex chemistry is more like making ice cream—it involves a more intricate process, and many people prefer to leave it to specialists. NF: Another fascinating challenge: in the lab, you work at milligram or gram scale, but factories must produce tons. How do you scale from a teaspoon to a truckload without ruining the recipe? RL: That is indeed our biggest daily challenge. Scaling up requires understanding every variable in the process. Going from a small kitchen setup to industrial production is not just about bigger equipment—it requires entirely different systems and expertise. We work with multidisciplinary teams—chemists, engineers, analytical specialists—to control every variable that affects product quality. In a typical GMP (Good Manufacturing Practice) process, there are 4–5 main steps. And across those steps, we may need to control around 350 variables to ensure the final product meets quality standards for patients. NF: When people think of chemistry, they often think of something negative. But Hovione has been developing more sustainable approaches. What does sustainable chemistry mean in practice? RL: Sustainability is a daily priority. We design processes with sustainability in mind from the very beginning. We follow green chemistry principles—avoiding harmful reagents whenever possible. And when that is not possible, we apply the “four Rs”: reduce, reuse, recycle, and recover. For example, just as the paint industry moved from solvent-based to water-based systems, we are also moving toward chemistry in water. This reduces the carbon footprint of our processes. We are also exploring micellar chemistry, flow chemistry, and even reactions without solvents at all—similar to grinding ingredients together with a mortar and pestle. These approaches help reduce waste and improve efficiency. NF: Looking to the future—will chemistry remain our best tool to save lives, and in a more sustainable way? RL: Absolutely. That is what motivates me every day. Artificial intelligence is already helping identify targets and design molecules—but those molecules still need to be produced. That is where chemistry remains essential. It is the foundation for creating and improving medicines. Innovation and sustainability will go hand in hand—and that is the path we are committed to. NF: Rui Loureiro, thank you for helping simplify chemistry and for showing this more sustainable side of science. This was the second episode of “The Next Discovery.” In the coming weeks, we will continue exploring this world. In the next episode, we will look at the future of particle engineering.   You can listen to the next episodes on observador.pt and on your usual podcast platform. See you at the next discovery.      

Article
Observador Lab, 25 june 2026

Podcast “The Next Discovery” (EP2) - Complex chemistry, real impact

Jun 25, 2026

The podcast "The Next Discovery" is a six-episode series created by Observador, a leading Portuguese digital newspaper and radio station, in partnership with Hovione. And what if some of the scientific discoveries that can improve the lives of millions of people were happening right now in Portugal? The Next Discovery. Listen to the first episode of the podcast here, featuring Diane Villax, co-founder of Hovione. [English transcription] Welcome to The Next Discovery. This is a series of conversations, created in partnership between Observador Lab and Hovione, an international pharmaceutical company of Portuguese origin, that will open the doors to its world and share real stories of science, innovation and global impact. Over six episodes, we will meet the people behind technologies that help develop and manufacture innovative medicines for the world’s largest pharmaceutical companies that improve the lives of more than 80 million patients every year. I am Nelson Ferreira and, in this first episode, we will discover how an unlikely story, which began in a basement in Lisbon, became a story of global leadership. To talk about this legacy, I have the honour of welcoming Diane Villax, co-founder and non-executive board member of Hovione, who at the age of 91 remains a living witness to this journey. Nelson Ferreira (NF): Welcome, Mrs Diane Villax. Let us begin our conversation in 1959. Hovione was born in an unlikely way, in a basement in Lisbon, founded by your husband, Ivan Villax, by you and by two other partners. How did you manage family life and, at the same time, the birth of a pharmaceutical company, all in the same space? I imagine that created some interesting logistical challenges. Diane Villax (DV): From the beginning, we decided that we would manufacture raw materials for the pharmaceutical industry, that is, the active ingredients of medicines. We had no money, so it had to start from our home, which was in a residential neighborhood in Lisbon. Right from the start, we divided the tasks. My husband, a brilliant Hungarian chemical engineer, would be the inventor, the producer and the salesman, while I would take care of all the administrative side: imports, exports, accounting and banks. I kept those responsibilities for at least 30 years. At the same time, we also thought about the values that would guide us over this long period: transparency, innovation, the pursuit of excellence and great consideration for everyone who would come to work with us over the years. NF: Very early on, your husband made it clear that Hovione would not compete on low price, but rather on quality and on solving complex problems. What was it like to apply this principle of rigour when resources were still scarce? Especially because, from day one, it always seems to me that your objective was global. The world would be your market. DV: From the beginning, we felt that Portugal, with a population of 10 million people, would not be a very significant market, and that the world would be ours. Perhaps we were a little naïve, because we were entering a global market that was already quite sophisticated. But the decision was made and we moved forward. We moved forward and were fortunate that Japan discovered us quite quickly. They came knocking on our door, because of course we did not have the means to knock on theirs. At that time, they did not manufacture; they only formulated, so they needed to buy raw materials. My husband had invention patents for independent processes and there were long discussions. They felt that our technology was good, our IP was very robust and our quality was excellent. This led to a cooperation that lasted 10 or 15 years and was very profitable for both sides, I believe. NF: In the 1980s and 1990s, Hovione took a more significant leap forward. What were the decisions, the technological bets or even the moments of greatest courage that allowed this small Portuguese company to become a leading multinational? DV: In 1982, after a successful inspection by the FDA, the regulatory authority in the United States of America, we entered the American market with our generic doxycycline antibiotic. The inventor’s patent had already expired and we had an independent manufacturing process. It was a huge, demanding and competitive market, but one that respects good service and quality. And it was indeed a major leap, because the market was so large that we had no real sense of what it would mean, and demand was much greater than what we were able to produce. I remember, it must have been the summer of 1983, many people probably had to postpone their holidays to the autumn or winter, because missing delivery deadlines was not an option. Later, in the 1990s, we entered a new business area: services. We realized that large American pharmaceutical companies, as well as small biotechs, were increasingly inclined to outsource the development work for new molecules. This is a very long period, which can take four, six or even 10 years — the development process for new molecules before they are approved by regulators and become commercial products. So we began to offer this development service, and it went very well. From there, we developed new technologies, such as spray drying, for poorly soluble molecules, because this could greatly increase their bioavailability. Today, this services area is our largest business segment. NF: Hovione today works with 19 of the world’s 20 largest pharmaceutical companies. How do you maintain the agile, pioneering spirit that was born in that basement, when today the company has 2,600 employees, more than 300 scientists, and has even become the largest private employer of PhDs in Portugal? DV: Agility has to be maintained. For example, during the pandemic, we suddenly received large, unexpected orders to manufacture a component of Remdesivir, which was the product authorized to help Covid patients. So agility has to be maintained, and we always maintain our quality. Today, with more than 60 years of history, clients come to us because they know they can count on our quality and on our responsibility to produce and deliver on time what they order. NF: There is another impressive figure here. Your products reach 80 million people every year and Hovione participates in up to 10% of the new medicines approved annually by the FDA in the United States. When you look at this impact, do you feel that the dream of 1959 has been fully achieved? DV: I think it has been far exceeded. When we founded Hovione, my husband, who was a scientist, simply wanted to have his own laboratory. But he never imagined that we would develop in such a way that, today, we are sought out by major international pharmaceutical companies, which frequently come to us. NF: This is a series about science, but it is also about people. And the rigour, ethics and long-term vision that Diane always brought to management are still present at Hovione. What message would you leave to the scientists who join Hovione today with the mission of finding the next discovery? From what I understand, Diane makes a point of welcoming them whenever they join the company. DV: Yes. Four times a year, twice in English and twice in Portuguese, I speak to the newcomers at Hovione, giving them a very brief account of our journey, our values, our objectives, our dreams, the challenges we faced and how we overcame them to get to where we are today. And I always recommend that anyone who joins this company must work with passion. They must work with passion and always remember that our work is to produce medicines for those who need them. We have the privilege of serving patients. We are a company that works for society. I think “In it for life”, which is our motto, has a lot to do with us, because we have been here for 67 years as a family company, and that is how we intend to continue for many good years to come. Above all, in the healthcare sector, there is a great advantage, because we can look at the long term. We do not have to think about stock market results every quarter, as public companies do. And, on the other hand, we are here precisely to give life to those who need it. “In it for life.” NF: At the age of 91, how does Diane herself maintain this passion and continue to make long-term plans? DV: Because I was a founder of this company. I see it progressing and developing successfully, so it is a joy for me. And I have a large family coming after me. I have six grandchildren and seven great-grandchildren, and I hope to leave the company to them so that they can continue it as I managed it. NF: That is truly inspiring. Mrs Diane Villax, thank you very much for sharing the memories and inspiration of this legacy, which remains very much alive. It was a privilege. This was the first chapter of The Next Discovery. In the coming weeks, we will continue to open the doors of Hovione to discover how Portuguese talent is leading the world, from complex chemistry to particle engineering, from respiratory therapies to next-generation biological medicines.   You can listen to the next episodes on observador.pt and on your usual podcast platform.    

Article
Observador Lab, 18 june 2026

Podcast “The Next Discovery” (EP1) - From a basement in Lisbon to global impact

Jun 18, 2026

The CDMO is preparing for its New Jersey facility to become fully operational this year. Hovione’s multimillion-dollar investment in expanding its East Windsor, NJ manufacturing site is quickly coming to fruition. Contract Pharma will be visiting the site later in April 2026 to provide a unique overview of what’s new. As a preview, the Contract Pharma team met with Hovione at the Drug, Chemical & Associated Technologies Association (DCAT) Week. David Basile, Vice President of Technical Operations—Americas, spoke at the opening Member Company Announcement Forum on March 23, 2026. In this interview, Basile expands on his remarks at the Announcement Forum. As he explains, Hovione is concentrating not only on New Jersey, but also on facilities in Ireland and Portugal. Contract Pharma: Good manufacturing practice (GMP) operations will soon be fully operational at the New Jersey facility. How has Hovione progressed through this process since the initial investment cycle was announced last fall—or even prior? David Basile: It’s been a really great journey and evolution over the last two to three years, conceiving the plan to grow our U.S. footprint. It was one of the reasons I came aboard with Hovione, to grow that footprint and build our commercial manufacturing prowess in the States. In New Jersey, we had originated [the site] as a tech transfer center. [But] we wanted to grow the organization to be more equivalent with our Portugal and Ireland sites, to do more large-scale manufacturing. So, this is part of that journey. And that’s not just bricks-and-mortar and machinery. It’s been people, talent, partnerships with clients, supporting functions such as QC [quality control] and analytical development. We’re growing our R&D teams as well. It’s a comprehensive approach to systems, people, and processes. CP: At the Member Company Announcement Forum, you ran through some of the major technical specifications of the NJ expansion. Can you talk about a few of the highlights and their capabilities? Basile: This year we’ll be starting up two PSD-3 scale spray dryers. This is a useful scale of machinery for our clients. It plays nicely between the PSD-2 and PSD-4 scales that we have elsewhere in the network. I’d say it’s medium-to-large scale capacity; we could do 30 metric tons annually out of this type of a unit. Product to product, that differs, but we do have products that put that kind of volume out in a PSD-3, so it’s not small-scale. Customers want to hear this because [they want to gain] efficiency with their batch size, and turnaround time. And when we campaign, we can really see significant throughput with this line up of new machinery and assets. The first machine that we will start up is a Hastelloy unit, which is unique. We took a pause [in the construction timeline] to make that upgrade, as we had a client that needed this configuration. There are additional clients that are interested in it too, because you can do acidic solutions and more aggressive kinds of formulations as well as solvent-based formulations. So that’s a unique element of that first machine. The second machine is being qualified later this year. Kind of a twin, but this one is standard 316 stainless steel.  CP: When a company brings a new or expanded facility online, new personnel often accompanies the new tech. What is the workforce addition that you expect, and what are the challenges of retaining top talent? Basile: In preparation for commissioning and startup of this new equipment, we’ve already ramped our headcount up, to be ready for GMP launch. We’ve added roughly 20 employees in preparation for this first machine to go [live]. Over the next 18-plus months, we could see something on a similar scale, getting us up to that 40–50 headcount range for that facility once it’s fully operational—and more later on in 2028, when we bring in the CDC [continuous direct compression] Flex unit. That’s what’s really going to be transformative about this new facility: that integrated offering coming to life. CP: Even if the NJ facility is top of mind right now, let’s also touch on some of your plans in Europe. What is your vision for expanding in Europe in the next two to three years? Basile: Ideally, Hovione’s aim is to build an equivalent manufacturing network, where clients can go to any site across the globe and get a similar breadth and scale of offering. We’re doing that now in Ireland, expanding our PSD-4 scale spray drying. One unit was recently installed. Late last year, it went live. Then there’s at least one other new PSD-4 in motion, which is really exciting, because [spray dryers] at this site were historically [exclusive to] larger chemistry manufacturing for API [active pharmaceutical ingredient] synthesis. So now, they’re further building their muscle with additional large scale spray drying capacity. On the Portugal side, there’s a lot of great things going on. Our Tejo campus, in Seixal, Portugal, is a massive, 4.5-million-square-foot plot of land, and there’s a new, modular facility going up there. It’s incredibly exciting. The design of the facility has been well-thought through with material flows [and] gravity-fed processes. Here, we minimize handling and [maximize] speed of processing. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets within each unit. So, why is that relevant? Because we can easily scale the number of fingers. When customers say, “we need more capacity,” we have the design on the table ready to go. We know how to execute, we know how to build and implement our technology platforms in a short timeframe. Deployment timeframes are truly becoming more and more relevant to our clients. CP: From last year’s DCAT Week to this year’s, what conversations are you having with industry colleagues about ever-changing geopolitics? Basile: We’re seeing that local, regional manufacturing capacity is vital. The concept of U.S. for U.S. and China for China seems to be a common theme that our clients are talking about. We happen to have an edge, as we [have already] started our journey of expanding our domestic U.S. capacity. So I think that’s a crucial piece to the puzzle, having dual-sided Atlantic manufacturing operations. The traditional global supply chain model is being challenged. Having soup-to-nuts sites that are fully autonomous in development, scale-up, tech transfer, all the way to commercial scale operation, is vital to Hovione, and how we’re protecting our supply chain. [Concerning] starting raw materials and Tier 2 suppliers, our procurement teams are out in the market making sure that there’s no single point of failure for critical materials [like] polymers and solvents that we utilize. We’re managing and mitigating risk by looking at those secondary suppliers across different geographies. CP: Encapsulating your planned expansions on both sides of the Atlantic, how would you sum up the value to the customer? Basile: It’s about speed-to-market. It’s one partner from early-phase development, clinical scale, all the way through commercial. They gain comfort, trust, and not just capacity and equipment time; it’s also about competency and depth of scientific expertise. We’re not just a traditional CDMO. There’s unique expertise in particle science and spray dried dispersions that we offer our clients that they don’t have. [With] traditional CDMOs, customers typically pay for time in [a particular] unit, for example, they’d say: “I need a machine, and I need [it for] three weeks.” Hovione is truly a partner to our clients. They’re leveraging our platforms, our know-how in spray drying, and our know-how in equipment design. Read the article at ContractPharma.com  

Article
Contract Pharma, 6 April 2026

Hovione Eyeing Manufacturing Expansion on Both Sides of Atlantic

Apr 06, 2026

Continuous manufacturing has long promised faster development, improved process understanding and, in the absence of scale-up, smoother commercialization. For many pharmaceutical R&D teams, those benefits are well understood. What still holds them back, however, is not scepticism about the concept; it’s the perceived effort required to implement it To increase the adoption of continuous manufacturing, particularly for tablet compression applications, GEA and Hovione have been working together to overcome these hurdles and demonstrate how solutions such as SimpleCT can accelerate development, provide greater flexibility and simplify production. Manufacturing Chemist spoke to Anthony Tantuccio (pictured), Fellow Scientist, Continuous Tableting/Technology Intensification at Hovione, to find out more.  Simplifying continuous operations: lowering the barrier to faster development Continuous manufacturing (CM) solutions can accelerate product development, reduce costs, improve operational economics and make production more agile with less downtime. With advanced controls and tightly linked process data to product output, it enables more consistent tablet quality. “It’s a more efficient and flexible mode of manufacturing,” notes Tantuccio, “offering consistent and reliable tablet production with fewer operators and less waste of precious active pharmaceutical ingredients (APIs) and raw materials.” “Yet,” he adds, “running a continuous direct compression (CDC) line during development can often be a daunting task.” Any inherent complexity stems from managing parallel, integrated operations that all occur at the same time (as opposed to a single unit operation). “Even relatively straightforward duties — such as collecting samples, changing process conditions or running Residence Time Distribution (RTD) tests — can become multi-person activities with a high potential for error.” SimpleCT focuses on simplifying these development-critical tasks, not by removing flexibility but by embedding automation, structure and guidance directly into the equipment and control systems. The result is a toolset designed for how R&D teams develop continuous tableting — mapping a design space and generating calibration samples within a single run — while reducing manual co-ordination and increasing confidence in the data generated. “Rather than treating continuous development as a scaled-down version of commercial manufacturing,” explains Tantuccio, “SimpleCT recognises that development has different priorities: rapid learning, efficient experimentation and robust process insight.” Accelerating development cycles and time to market One of the most immediate benefits of SimpleCT for R&D teams is speed. Development programmes on continuous lines can be significantly shortened when routine yet complex tasks are automated and synchronised across the system. “During many development scenarios,” says Tantuccio, “Design of Experiments (DoE) execution remains largely manual and labour-intensive — introducing inefficiencies, safety risks and data variability at a time when consistency and speed are paramount.” Tools such as assisted DoE (ADoE) allow development steps to be predefined and executed automatically. Instead of manually adjusting dozens of parameters under time pressure, operators can progress through experimental conditions in a controlled and repeatable way. This reduces the setup time between experiments and minimises the risk of incorrect parameter entries or missed steps. “Shorter development cycles translate directly into faster decision-making and earlier progression to clinical or commercial stages,” adds Tantuccio: “Even a modest reduction in development time — measured in weeks or months — can have a meaningful impact on time-to-market and overall project value. Furthermore, unrealised capacity can become available.” Speed alone is not enough, though; R&D teams also need confidence in their understanding of the process. SimpleCT enhances operational insight by improving how information is presented and captured during development. More detailed screens, clearer alarm messages and time-aligned datasets help operators to understand not just that something has happened … but why it happened. At the core of SimpleCT is the ability to define and execute multivariate experiments within clearly defined operating ranges by a single person. Reducing reliance on specialised personnel Traditional continuous development often assumes the availability of highly experienced operators or process engineers who can manage simultaneous set-point changes, sampling schedules, data alignment and troubleshooting in real-time. In practice, this creates a bottleneck: development becomes dependent on a small number of experts. “SimpleCT is designed to lower that dependency,” suggests Tantuccio. “Automated sampling systems, guided workflows and more informative operator interfaces allow development activities to be done by fewer people with less reliance on niche expertise. For example, automated tablet sampling systems can collect, bag, label and link samples to their respective process conditions at high frequency without manual coordination and management.” Similarly, automated residence mass collection enables system measurement of how much material is present in the blender during steady operation — a standard requirement for understanding mixing behaviour — and time-aligned data capture at the touch of a button. Tasks that previously required multiple operators working closely together can now be performed safely and consistently by a single trained user. “This reduction in headcount pressure is particularly valuable in R&D environments when resources are limited and teams are balancing multiple programmes simultaneously,” Tantuccio adds. Improving process insight during development Manual “spiking” operations have historically posed safety and operational concerns. Spiking involves adding a tracer powder to the process and monitoring its passage through the system, enabling mapping of residence time and identification of key process dynamic behaviour. These activities frequently require operators to work in proximity to moving equipment and APIs, sometimes under time pressure. Clear communication between the operators responsible for spiking, sample collection and human–machine interface (HMI) adjustments is essential, yet even minor misalignments can compromise data integrity or create safety risks. “As the number of experimental runs increases, so too does the likelihood of human error, mislabelling or incomplete data capture,” comments Tantuccio. Automated RTD tools, such as contained automatic spiking (CAS) systems, ensure accurate timing, consistent spike introduction and full time-alignment between process data and experimental events. This removes a common source of uncertainty in RTD studies and allows teams to focus on interpreting results rather than questioning data quality. “By reducing manual steps and human error, SimpleCT supports smoother experimentation and faster learning — enabling teams to identify operating windows, sensitivities and transfer risks earlier in development.” A pragmatic path to continuous adoption “Importantly,” enthuses Tantuccio, “SimpleCT is not positioned as a radical departure from existing development practices. It is a pragmatic, application-based enabler for teams that already see the value of CM but have hesitated because of its perceived operational complexity.” The SimpleCT toolset integrates across GEA’s continuous ecosystem — including CDC and related technologies. This lowers the psychological and operational barrier to entry, making continuous development feel manageable rather than overwhelming. “For many pharmaceutical organisations, this derisking effect is just as important as speed or efficiency. By simplifying day-to-day development activities, SimpleCT allows teams to build confidence in continuous tableting early, thereby creating a stronger foundation for later development stages and commercialisation,” Tantuccio adds. From complexity to confidence The take-home message from Tantuccio is that continuous manufacturing doesn’t need to be complicated to be powerful. “For R&D teams, the real challenge has never been understanding the theory; it’s been managing the practical realities of development on integrated, all-at-once and always-on systems.” By removing manual handling and co-ordination from critical development steps, SimpleCT from GEA and Hovione delivers tangible benefits in three key areas: reliability, ease of operation and data assurance. Automation minimises the risk of human error for standardised workflows, whereas push-button execution allows complex multivariate experiments to be done efficiently and safely. The quality and consistency of the data generated provide a strong foundation for process understanding, supporting faster decision-making and more robust commercialization activities. By automating complex tasks, reducing headcount requirements and improving process insights, SimpleCT enables faster, more confident development on continuous lines. “For teams ready to move beyond batch — but looking for a simpler way forward — continuous has just become easier,” concludes Tantuccio. “With SimpleCT, you can take the complexity out of continuous development and get to market even faster.”  SimpleCT: accelerating time-to-market In an increasingly competitive landscape, the ability to develop and optimise tablet formulations quickly can provide a decisive advantage. Part of GEA’s ConsiGma® portfolio, SimpleCT supports the faster development of direct compression products, reduces material consumption during experimentation and shortens overall time-to-market. At the same time, improved operator safety and reduced exposure to APIs align with the industry’s ongoing focus on sustainable and responsible manufacturing practices. Read the full article at ManufacturingChemist.com  

Article
Manufacturing Chemist, 2 April 2026

Simplifying continuous operations: lowering the barrier to faster development

Apr 02, 2026

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

Article
Fierce Pharma, 26 March 2026

As expansions come online, CDMO Hovione aims to meet industry's 'dual supply and sourcing' zeal: exec

Mar 26, 2026

International Pharmaceutical Industry journal speaks with Márcio Temtem, VP Strategic Business Management at Hovione, about how the company’s deep-rooted expertise in complex chemistry differentiates it within the CDMO landscape, enables seamless integration from drug substance to drug product, and supports partners in accelerating the development of high-potency APIs, advanced formulations, and next-generation therapeutic modalities. How does your complex chemistry expertise differentiate you from other CDMOs and how does it translate into helping partners accelerate the development of increasingly sophisticated APIs and formulations? Hovione has been associated with complex chemistry since its genesis. The company started by developing very tough chemistry on corticosteroids and antibiotics, which was an expertise that in the 90s we transferred into the contract manufacturing business.  Since then, Hovione has been exploring chemistry and its complexity in contract manufacturing through several angles. One is the ability to have assets across the globe and at different scales that allow the company to address various client needs. Another example of being able to tackle the complexity is having assets that can address molecules with different levels of potency. High potency is something that we offer in many of our facilities. Over the years, we have also tackled chemistries that are difficult to manage, like hydrogenations and cryogenic reactions. All these are part of a menu that we offer into the services. Hovione is always attentive to the client’s needs. The next step after chemistry, which typically tends to be particle engineering, either by means of crystallisation, controlled crystallisation, jet milling, or one of the technologies that we master most, spray drying. We keep attentive to these needs and we keep upgrading our toolbox with new hardware and new software. On the hardware side, we recently announced a partnership with Microinnova to embed continuous flow into our offering. On the software side, we have added micellar chemistry, a water-based approach to chemically synthesise active ingredients, addressing sustainability within the broader pharmaceutical industry. How does your manufacturing approach ensure seamless integration from drug substance to drug product both technically and operationally? Hovione has sites located in Europe, Asia, and North America, designed to offer clients a seamless, integrated approach across our network, not only in terms of processes, but also in terms of technologies. These facilities serve clients globally, although naturally some clients favour the local site. In terms of integration, Hovione offers the synthesis of the active ingredient, the manufacturing of intermediates such as amorphous solid dispersions, and the final drug product all in one site. Many companies claim to offer integrated services, but they do this across multiple sites. Hovione does the integration at one site, which reduces hand-offs, streamlines operations and ensures technical alignment. How do technologies such as spray drying and particle engineering, when combined with your chemistry expertise, enhance formulation performance and streamline scale-up timelines? Spray drying has become one of the most versatile technologies in our industry. It addresses challenges that both chemists and formulators face. Chemists are often concerned with problems such as yield, purity or ways of obtaining the right solid-state characteristics of the API, such as polymorphic form. Spray drying can provide a means of isolating materials that are very difficult to isolate by other methods. Examples of compounds that benefit from this include peptides and sugars. On the formulation side, spray drying addresses one of the biggest challenges in the industry: the poor solubility and consequently bioavailability of most of the new drugs. Seventy to ninety per cent of the new drugs in development are poorly soluble. Over the past 20 years, Hovione has developed a platform for making amorphous solid dispersions by spray drying. This platform allows new formulations to be developed with minimum quantities of API and in a short number of few weeks. The technology provides a seamless scale-up from grams to tons, gives clients line-of-sight to commercial production, and saves valuable API at early stages of development. It also allows integration between drug substance and drug product, linking synthesis, intermediate manufacture, and final product in a single site, which is unique in the industry. As molecules and processes become more complex, so too do supply chains. How does Hovione ensure consistency, quality, and regulatory confidence across global operations? Hovione maintains consistency, quality and regulatory confidence through a combination of global assets, standardised platforms and processes, and cross-functional expertise. Our sites are designed to serve global clients while maintaining local responsiveness. We offer high-potency capabilities and advanced particle engineering to address complex molecular challenges. By standardising technologies and processes across sites, Hovione ensures predictable outcomes and adherence to global regulatory requirements. This integrated approach supports reliable supply chains even as molecules and processes grow more complex. With the rise of HPAPIs, novel excipients, and emerging therapeutic modalities, how is Hovione evolving its chemistry and process capabilities to support the next generation of pharmaceutical innovation? We see a trend towards more complex molecules and increasing demand for high-potency compounds. Hovione continues to invest globally, expanding capabilities in high-potency APIs, novel excipients, emerging modalities, and emerging delivery routes such as inhalation or nasal delivery. Chemistry is used as a tool to enable these delivery routes, including synthesis, crystallisation to achieve the right polymorphic form, shape, and size, and optimisation of interactions with excipients. All this is interconnected with our platforms, and amorphous solid dispersions by spray drying, designed to improve bioavailability, the one with the most market credits. Our capabilities bridge drug substance and drug product development and allow us to serve commercial products of different volumes, from small batches to larger scales, all while handling high potency and complex chemistries.   Read the full article at International-Pharma.com  

Article
IPI, International Pharmaceutical Industry Journal, 01 March 2026

International Pharmaceutical Industry journal speaks with Márcio Temtem, VP Strategic Business Management at Hovione

Mar 01, 2026

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).    

Article
Executiva, 23 February 2026

Hovione’s Diane Villax: “I was not brought up to be a business woman”

Feb 23, 2026

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  

Article
PharmTech, 6 February 2026

Hovione’s Strategy for Complexity, Speed, and Regional Supply Chains

Feb 06, 2026

Hovione is an international CDMO with over 60 years of experience in pharmaceutical development and manufacturing, providing a comprehensive range of services for New Molecular Entities (NMEs) including drug substances, intermediates, and finished drug products. Hovione also provides niche generic API products and delivers advanced technologies to support a variety of drug delivery systems, including oral, injectable, inhalation, and topical formats. Today, the company employs 2,500 people worldwide and offers 900 m3 of manufacturing capacity. Jean-Luc Herbeaux joined Hovione as Chief Operations Officer in 2020 and was appointed CEO in April 2022. Previously, he held multiple high-level leadership positions at Evonik, where he last headed the Health Care Business Line. Herbeaux earned a Diplôme d’Ingénieur from UTC in France and an M.S. and Ph.D. in Mechanical Engineering from the University of Houston in the U.S. In this Q&A with Contract Pharma, Herbeaux discusses Hovione’s leadership in spray drying and continuous tableting technologies, the fundamental purpose that drives the company, long-term growth strategies and more.   Contract Pharma: What are the most significant trends you are currently observing in the CDMO industry? Jean-Luc Herbeaux: Several powerful trends are currently reshaping the CDMO industry. First, we are seeing a rapid increase in the complexity of synthetic molecules. These compounds often require longer, more sophisticated chemical routes and access to specialized, qualified capacity. They also drive demand for advanced formulation technologies, particularly in particle engineering and bioavailability enhancement, where spray drying has become a key enabling platform. Second, development timelines continue to compress. Sponsors want to move faster, which significantly increases the pressure on manufacturing organizations. CDMOs are expected to design, build, qualify, and scale assets in much shorter timeframes. This challenge is amplified by the simultaneous launch of very large-volume products, where commercial capacity may not yet exist and must be created in parallel with late-stage development. These dynamics clearly favor CDMOs that already have available capacity, strong engineering depth, and proven capabilities in rapid, right-first-time scale-up. Third, the regionalization of supply chains is becoming a structural reality. Concepts such as “USA for USA” or “China for China” represent a fundamental shift for an industry that was historically optimized around globally integrated networks. CDMOs with a truly international manufacturing footprint and strong scalability are best positioned to support this transition and to meet the expectations of global pharmaceutical customers. Finally, all these forces are accelerating the evolution of customer relationships — from transactional outsourcing toward strategic, long-term partnerships. As regulatory standards tighten and customer audits become broader and more rigorous, CDMOs aspiring to be strategic partners must go well beyond technical excellence. They must demonstrate highly professionalized operations, robust quality systems, strong governance, and the ability to integrate seamlessly into their customers’ development and supply strategies. CP: How does Hovione maintain its leadership in spray drying and continuous tableting technologies? Herbeaux: Establishing and maintaining leadership demands focus, discipline and commitment to continuous improvement. Decathletes are versatile but rarely dominate a single event. Similarly, I believe pharma CDMOs must decide whether to focus on selected technologies to achieve excellence or maintain a broad offering with inevitable compromises in depth and focus. At Hovione, we have chosen to specialize, dedicating over 20 years to perfecting spray drying. Thanks to this dedication, we have built unmatched know-how in particle engineering, scale-up, and industrialization, by optimizing materials, formulation, process design, automation, hardware design, and nurturing internal talents and partnerships. Specialized CDMOs like Hovione are uniquely positioned to lead this journey, given their exposure to a far broader range of compounds than any individual pharmaceutical company encounters within its own development pipeline. Our journey in continuous tableting is more recent, yet it follows the same playbook: we apply the same disciplined, end-to-end rigor across processes, hardware, automation, talent, and partner networks to drive usability and adoption. We do so by weaving innovation and continuous improvement into everything we do, with all our team members and partners contributing. This specialized approach has made Hovione very relevant to the pharmaceutical market, not by virtue of size or volume, but through the differentiation achieved in these areas of heightened focus. In turn, this contributes to the creation and reliable supply of superior therapies to the most important stakeholder group – patients. CP: How is Hovione integrating new technologies and innovations in its processes? Herbeaux: At Hovione, we believe in advancing the quality of our services through science and technology.  Our scientific expertise helps bring performance and predictability to the development and manufacturing processes we employ to deliver drug products and their intermediates to our customers, ensuring consistently high-quality results at all scales. Our approach to innovation integrates co-development with our partners and customers to adopt innovations that accelerate development and constantly improve product and process performance. Digital tools and automation—like PAT, advanced analytics, and in silico modeling—are obviously integrated in our processes to improve control, speed, and outcomes. By focusing on innovations that have a real impact, Hovione supports up to 10% of the NDAs submitted to the FDA on any given year and contributes to medicines that reach about 80 million patients. This reflects our dedication to improving patients’ lives. At the core of our identity is this fundamental purpose that guides everything our 2,500 team members do: “We are in it for life.” CP: What is Hovione’s long-term strategy to grow its U.S. operations? What progress has the company made recently? Herbeaux: The significant growth of our New Jersey site in recent years reflects the combined effect of a deliberate strategic decision to reinforce local capabilities and teams —bringing us closer to our customers and their end markets. Our “one-site-stop” approach—bringing together drug substance, drug product intermediate, and drug product capabilities at a single site under one quality system—resonates strongly with customers. This model reduces technology-transfer complexity, compresses timelines, and enables seamless execution from development through commercialization, directly addressing customer demand for accelerated timelines. We recently completed a $100 million investment cycle, including the construction of a 31,000 sq. ft. facility featuring two new commercial-scale size-3 spray dryers dedicated to amorphous solid dispersions (ASDs). This investment more than doubles our U.S. spray-drying capacity. The facility will also soon be equipped with a next-generation GEA continuous tableting line (CDC Flex) designed to accommodate a broad range of output levels, from development through commercial-scale volumes. Hovione has also acquired additional land to support a future 125,000 sq. ft. greenfield development. Together, these projects have the potential, over the next decade, to transform our New Jersey site into a fully integrated pharmaceutical manufacturing campus of more than 200,000 sq. ft. CP: What is Hovione’s growth strategy for the rest of the world beyond the U.S.? Herbeaux: The New Jersey expansion is part of Hovione’s multi-year, multi-continent investment plan to create a network of autonomous yet harmonized sites. In Seixal, Portugal, a €200 million investment in a 104-acre campus—including new production buildings, laboratories, and offices—is scheduled to open in 2027, providing clear line of sight for new business opportunities. In Cork, Ireland, a recently completed expansion nearly doubled our local spray-drying capacity. Together, these investments strengthen our key technology platforms— 1) amorphous solid dispersion via spray drying and 2) continuous tableting—enhancing capacity and ensuring redundancy to support global supply continuity. CP: Are there any recent collaborations or partnerships that have been impactful for Hovione’s trajectory? Herbeaux: Strategic partnerships with pharmaceutical companies (our customers) are particularly rewarding, as they entail long-term commitments, provide preferred access to rich portfolios and pipelines, and support our continuous evolution toward best-in-class performance. In recent years, we have secured a growing number of preferred supplier relationships, which have helped ensure long-term supply of complex drugs and intermediates for our partners while also mitigating risk in our own pipeline. Another category of strategic collaborations involves partners with capabilities that are complementary to ours. Through these collaborations, we expand our innovation ecosystem, enhance our capabilities to address the industry’s toughest challenges, and leverage top industry talent to create value that benefits and respects all participants. Our partnership with Zerion Pharma helps advance the Dispersome technology to boost bioavailability of small-molecule drugs, supported by our ASD-HIPROS intelligent screening platform to speed amorphous solid dispersion formulation development. Our technology partnerships with Dragonfly Technologies (micellar chemistry) and Microinnova (flow chemistry) enable greener, leaner chemistry. Our collaboration with GEA contributes to the higher adoption of continuous tableting with next generation continuous tableting machines, which are easier to use, more compact and address the customer requirement for accelerated development. Building on our leadership in spray drying, we are partnering in systems for respiratory drug delivery, such as dry powder inhaler device technology with H&T Presspart and nasal powder delivery devices with IDC in order to present a complete offering (API, powder, and devices) to the market. Last but not least, we are expanding our network to areas adjacent to our current commercial activities, most notably aseptic particles and formulations, with the goal of addressing drug delivery and stabilization challenges for new modalities. Our specialized synthetic sugars, which show potential in this area, came with the acquisition of ExtremoChem. We will share more details as this offering continues to mature. CP: From a sponsor’s perspective, what should companies look for when choosing a CDMO for early-phase development of complex formulations? Herbeaux: When faced with the difficult task of selecting a CDMO, I would recommend choosing a partner with proven capabilities in the relevant area—particularly when it comes to scaling from early development to commercial production. I would select a CDMO that helps the customer make the right scientific and technical decisions early, anticipating scale-up challenges before they arise. Ultimately, I would choose a partner for the long term, equipped with the right team (including management), equipment, methodologies, quality and regulatory expertise to de-risk both the clinical and commercial programs. A long-term partnership fosters a transparent, collaborative model, supported by strong data protection, with the CDMO functioning as an extension of the customer’s team.  As trust is established and team dynamics are proven, partners can successfully pursue projects even beyond the CDMO’s core technologies, leveraging close collaboration and higher levels of integration to ensure successful outcomes. In my experience, nothing delivers more long-term value than a network of trusted partners. CP: As the CDMO space becomes increasingly crowded, how is Hovione differentiating itself in the eyes of emerging biotech and mid-sized pharma clients? Herbeaux: Our customers’ trust is our most valuable asset. It underpins every collaboration we build and is earned through the depth of our scientific expertise, efficient and reliable manufacturing, strong quality systems, sustainable practices, and long-standing regulatory excellence. This foundation is reflected in the trust placed in us by 19 of the world’s top 20 pharmaceutical companies, as well as many mid-sized pharmaceutical companies and biotech organizations. That trust is never taken for granted. It is earned and reinforced through our continuous efforts to help our customers address their most complex challenges and advance their drug programs with dedication, confidence and timeliness. As a family-owned company with a stable and experienced management team, we provide a clear long-term vision and consistent strategic direction—qualities our customers value highly. Having grown organically with patient outcome in mind, we deeply appreciate that every project matters—both to our pharmaceutical partners and, most importantly, to the patients whose lives depend on the successful launch and delivery of these medicines. Emerging biotech and mid-sized pharma clients can rely on the superior level of engagement and service that has made Hovione successful. Through our integrated model, we support the development and manufacturing of drug substance, drug product intermediates, and finished drug products for both clinical and commercial applications—enabling smooth scale-up, consistent results, and accelerated timelines. Our R&D and operations teams work in close partnership, coordinated by best-in-class project management practices, to ensure fast, reliable transfer from laboratory scale to GMP industrial production, maintaining speed without compromising quality. Throughout every stage, quality and compliance remain at the core of our work, with unwavering adherence to the highest standards. Our leadership in platforms like ASD by spray drying and continuous tableting, together with our capability to drive projects to success at any scale, remains a key source of value for emerging biotech and mid-sized pharma, especially as advanced formulation challenges grow more complex.   Read the full article at ContractPharma.com  

Article
Contract Pharma, 12 January 2026

CEO Spotlight: Hovione’s Jean-Luc Herbeaux

Jan 12, 2026

Key Takeaways Multiple departments, including engineering and quality assurance, are responsible for evaluating GMP equipment and facilities. Regulatory inspectors require well-organized, preferably digital, maintenance documentation during GMP audits. A computerized maintenance management system (CMMS) is crucial for tracking maintenance activities and ensuring high performance. Common mistakes include neglecting criticality assessments, relying solely on time-based maintenance, and failing to consider maintainability during design. Adequate commissioning time is crucial for equipment lifespan and maintenance reliability. Construction and maintenance of manufacturing buildings and equipment fall under good manufacturing practices (GMPs) regulations (1–5). Pharmaceutical manufacturers can comply with these rules in the form of risk-based maintenance programs. 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. At Hovione, we have a dedicated reliability engineer and maintenance planner that help in the evaluation. This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution. These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands on experience. In fact, the best planners are usually seasoned mechanics. One final failure we see often is not building in enough time for commissioning. The lifespan of equipment can be greatly influenced during the commissioning phase. This is where maintenance reliability starts. Too often, commissioning is rushed through, and equipment and preventive maintenance plans and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis. Read the full article at Pharmtech.com  

Article
Pharmaceutical Technology, 26 December 2025

Missteps in GMP Facilities and Equipment Maintenance

Dec 26, 2025

David Basile, Vice President of Technical Operations for the Americas at Hovione, has identified several recurring errors made by pharmaceutical companies in the maintenance of manufacturing facilities and equipment. These missteps occur within the framework of Good Manufacturing Practices (GMP), which are critical for ensuring product quality and compliance with regulatory standards. Basile points to a range of issues that commonly arise, including inadequate preventive maintenance programs, improper documentation practices, and insufficient training for personnel responsible for equipment upkeep. He also highlights challenges related to aging infrastructure and the failure to implement modern technologies that could improve efficiency and reliability. These shortcomings can lead to operational disruptions, increased costs, and potential regulatory non-compliance. The observations underline the importance of robust maintenance strategies in maintaining high standards within pharmaceutical manufacturing environments. Read the full article at Geneonline.com  

Article
Gene Online, 26 December 2025

Recurring GMP Maintenance Errors Identified by Hovione VP David Basile in Pharmaceutical Manufacturing

Dec 26, 2025

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  

Article
Les Echos, 2 December 2025

Jean-Luc Herbeaux aims to boost the growth of the pharmaceutical group Hovione

Dec 02, 2025

US-base manufacturing and the continued rise of peptides were among the key themes for CDMOs at CPHI Frankfurt 2025. Andrew Warmington reports. Hovione announced during this show that it has completed an initial $100 million investment phase in the expansion of its manufacturing footprint in East Windsor, New Jersey. The company was one of the first European CDMOs to set up in the US back in 2002. CEO Jean-Luc Herbeaux said that when he took over the role four years ago, Hovione's footprint in the US was limited and the site was reaching capacity limitations. (...) Read the full article on SpecChemOnline.com  

Article
Speciality Chemicals, Nov./Dec. 2025

Coming to America - Drug Product Focus

Nov 01, 2025

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