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Article / Nov 27, 2020

Europe’s drug supply chain gets ready for a makeover

C&EN, 20 May 2019

As the European Commission prepares a new pharmaceutical strategy, manufacturers seek financial support and technology investment

by Rick Mullin

NOVEMBER 27, 2020 | APPEARED IN VOLUME 98, ISSUE 46

 

When the COVID-19 pandemic exposed weaknesses in the pharmaceutical supply chain in the US—in particular its dependence on products outsourced to Asia—the government responded forcefully. The Trump administration led with an initial grant of $354 million, with a possible $458 million to follow, for a newly formed company, Phlow, dedicated to manufacturing critical active pharmaceutical ingredients (APIs) domestically.

Next came a letter of intent for a $765 million loan to Eastman Kodak to convert a specialty chemical plant at the company’s headquarters in Rochester, New York, into an API manufacturing complex dedicated to “reshoring” pharmaceutical chemicals from China and India.

Now it’s Europe’s turn. The European Commission (EC) has been studying the global supply chain, setting itself a year-end deadline for delivering a drug and health-care strategy. Proposed road maps solicited by the EC from manufacturers of APIs and finished drugs illustrate differences between the US approach and Europe’s possible path to self-sufficiency in pharmaceutical manufacturing.

In a meeting in April with the European Union conference of presidents, the EU’s health and food safety commissioner, Stella Kyriakides, raised the matter of supply chain vulnerabilities exposed by the COVID-19 pandemic. Kyriakides cited “structural weaknesses in the EU’s medicines supply chain and a high dependence on non-EU countries for active pharmaceutical ingredients” and recommended that supply chain issues be addressed in an EU strategy. The EC solicited public comment on the proposed strategy in June.

Judging from the recommendations put forward by European associations representing drug and pharmaceutical chemical firms, the commission’s approach will differ significantly from the tack taken by the outgoing Trump administration. Rather than spending millions of euros launching made-in-Europe ventures, the EC will likely leverage a sizable established manufacturing base. Likewise, industry guidance for Europe’s plan places greater emphasis on making its supply chain more secure rather than less global, while maintaining and expanding the region’s manufacturing footprint.

Adrian van den Hoven, general director of Medicines for Europe, an association of generic-drug and API makers, stresses that reshoring cannot be viewed as simply resuming the manufacture of products that have been outsourced to China and India. “It’s a question of making it sustainable to invest and continue to invest in Europe,” van den Hoven says. “We still have a pretty robust industrial footprint in Europe, with a lot of capabilities.” But growth has flattened in recent years, he adds, as manufacturers in countries like India have taken market share.

 

Pharmaceutical Supply Chain API Manufacturing Management team | Hovione
Luis Gomes, second from left, with his production management team, advocates selective reshoring and investment in technology.

 

Medicines for Europe’s proposals to the EC include a change to generic-drug pricing, which individual countries currently set at the lowest possible levels to reduce the cost of subsidized health care. The association proposes a scheme that would allow prices to be negotiated from the bottom up based on a supplier’s cost of goods, regulatory costs, and other considerations.

For hospital and retail purchases, van der Hoven says Medicines for Europe favors “multi-winner tenders,” in which buyers are required to purchase from several suppliers as opposed to awarding contracts to the lowest bidder, a practice that has fueled consolidation among drug suppliers.

The group also advocates government support for technology development. Van den Hoven points to Europe’s almost $900 billion COVID-19 recovery package, “The commission has made it clear that some of the funding will be available for technology investment by our sector,” he says.

Medicines for Europe also advocates global coordination of drug supply as opposed to rampant reshoring. “It is important that we maintain critical technologies in Europe,” van den Hoven says. “That said, we don’t believe we can or should produce everything in Europe.”

That view is seconded by Luis Gomes, senior vice president of operations at the Portuguese API firm Hovione. He’s also chairman of the Pharmaceutical Activities Committee of the European Fine Chemicals Group (EFCG), an industry association.

“I think the commission has an understanding that it needs to strengthen the production of pharma products in Europe in order to reduce the dependence and vulnerability of the supply chain,” Gomes says. “I think regulators need a kind of road map to pursue what I would call meaningful pharmaceutical production reshoring in Europe. That starts with priorities.”

The EC must arrive at a list of critical APIs that need to be manufactured in Europe, Gomes says. Those no longer made in Europe can be reintroduced, thus increasing the domestic manufacturing base. “And it’s not only APIs one cares about,” he says. “You are also dependent on supply of intermediates and building blocks. You need to look at the supply chain from an end-to-end perspective.”

Pharmaceutical chemistry presents a significant hurdle given that many of the reactions involved have disappeared from Europe in the wake of the region’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation and other environmental tightening over the past 2 decades. For example, REACH required expensive environmental controls on reactions such as nitration, fluorination, and bromination, which are critical to making certain drug ingredients. “I think REACH created an incentive for production of these chemicals to move to other places, especially Asia, but that doesn’t mean they cannot be manufactured again in Europe,” Gomes says.

Like Medicines for Europe, EFCG sees a need for the government to invest in green technology. Financial support will also be needed to establish European production of critical drugs and drug ingredients now made exclusively overseas.

Maggie Saykali, director of resins and fine chemicals at the European Chemical Industry Council (Cefic), says in an email that her trade association also has been in discussions with the EC regarding vulnerabilities in the pharmaceutical supply chain. Cefic is preparing a report with recommendations at the commission’s request.

“One of the pillars of our roadmap is selective reshoring of the critical technologies needed for the molecules for which long-term supplies must be guaranteed,” Saykali writes. “In order to be sustainable in the long run, this selective reshoring needs support for process innovation, expansion of existing EU production facilities and enforcement of a level playing field for the highest-quality safety, environmental, and social standards.”

Sources agree that continuous manufacturing technology will play a role in developing efficient and green manufacturing. They also agree that the Research Center of Pharmaceutical Engineering’s Center for Continuous Flow Synthesis and Processing (CC Flow) initiative at Graz University is the center of continuous technology development in Europe.

C. Oliver Kappe, scientific director of CC Flow, says that his lab is not communicating directly with the EC on the development of a reshoring strategy but that several of its partners are contract manufacturers and members of associations such as EFCG. Kappe says the lab plans to set up a facility near Graz, Austria, that will pilot the manufacture of both APIs and finished drugs in a fully continuous fashion.

Continuous manufacturing could help avert crises such as drug shortages during pandemics in Europe, Kappe argues. He notes that CC Flow has worked on a process for manufacturing remdesivir, a COVID-19 treatment developed by Gilead Sciences. It also has collaborated with a similar center in the US, the Medicines for All Institute at Virginia Commonwealth University. Medicines for All is a partner in Phlow, the company launched by the Trump administration to repatriate generic drugs.

While Europe has taken a few pages from the US response to the COVID-19 pandemic—the EU recently announced it would create a biomedical research agency comparable to the Biomedical Advanced Research and Development Authority, the US government agency that launched Phlow—the European path will inevitably differ. Observers note that Brussels is coordinating 27 independent countries’ efforts, ensuring a more protracted process than experienced in Washington.

One EU country has floated a Phlow-like venture with a view toward securing domestic supply of acetaminophen. The government of France is sponsoring a partnership with the French drug firms Sanofi and Upsa and the French API maker Seqens to establish domestic supply of the analgesic, which currently comes mostly from China. Seqens manufactures bulk acetaminophen there. Upsa and Sanofi manufacture most of the finished drug used in France, but they source API from China. The plan, still at a preliminary stage, would have Seqens add capacity for the API in France.

Van den Hoven at Medicines for Europe likes the hospital and health-care-facility purchasing strategy adopted by Phlow and its partner Civica Rx, a nonprofit launched in 2018 to help manage generic-drug prices and prevent shortages for member institutions. But he questions the US government’s decision to spend up to $800 million establishing a new company to foster domestic manufacturing of APIs.

“It’s an incredible amount of money,” he says. “In Europe, we can do it for a lot less.” He points to Sandoz’s deal with the Austrian government to invest more than $175 million at its site in Kundl, Austria, Europe’s last large antibiotics plant. “This is really small change for a production site that supplies half of Europe with penicillin,” van den Hoven says.

On Nov. 25 the EC issued its Pharmaceutical Strategy for Europe, which outlines a raft of initiatives the commission will put forward for approval by the European governing bodies. The strategy, which is not finalized, addresses many of the manufacturing issues raised by industry associations, including pricing policies and investment in green technology. But it lacks details on regulatory changes impacting the use of continuous process manufacturing, and it does not suggest the creation of a list of critical APIs. Van den Hoven says the commission is still fielding input from industry pending a finalized plan.

Europe’s drug manufacturers are awaiting further direction from the EC just as the world braces for a surge in COVID-19 infections that may reignite supply chain anxiety. Van den Hoven notes, however, that the first wave of the pandemic was marked by a cooperative response globally. For instance, Europe expedited the export of drugs used in intensive care units to the US despite crisis-level demand for the same drugs at home, he says.

“The political climate is a little tense right now,” van den Hoven says. “But at some point people are going to have to go back to cooperation again.”

 

Read the full article on C&EN website

 

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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 hospitals to patients’ homes, discover the solutions that make it possible to administer high-dose biologics with greater comfort, less pain, and more freedom in treatment. What if some of the scientific breakthroughs that could improve the lives of millions of people were happening right now in Portugal? The Next Discovery. Listen to the last episode of the podcast here, featuring João Pires and Joana Cristóvão from Hovione’s Research and Development Center. [English transcription] Nelson Ferreira (NF): Welcome to the sixth and final episode of The Next Discovery, a podcast series in which Hovione opens the doors to its world to share the global impact of innovation developed in Portugal. I’m Nelson Ferreira, and throughout this journey we have explored chemical processes, ultrafine particles, and revolutionary production lines. Today, we look directly at the future of medicine. After exploring the world of small molecules, we are now entering a new therapeutic dimension: biologic medicines. Based on larger and more complex molecules, these treatments are opening new possibilities for addressing a wide range of diseases. To explain how this field is evolving and how science can make these treatments more effective, stable, and accessible to patients, I’m joined by João Pires and Joana Cristóvão from Hovione’s Research and Development Center. NF: Welcome to you both. João, let me start with you. For someone who has never heard this term before, what exactly are biologic medicines, and what sets them apart from small-molecule drugs, which are more closely associated with traditional chemistry? João Pires (JP): If we think about the medicines we find in pharmacies today, most of them are indeed composed of small molecules. These are simpler structures that are still highly effective and that we can design and manufacture through what we call classical chemistry, a field that has developed its knowledge over the last 150 to 200 years. Biologics are completely different. Because of their complexity, larger size, and structure, they differ mainly in their origin. They are produced from living organisms, such as cells, which, under the right conditions, can function as biological factories. Just as in our own bodies, they allow us to produce and extract substances that can have a significant therapeutic effect for certain diseases. In that sense, biologics benefit from millions of years of evolution, something classical chemistry simply does not have. NF: Biology is what carried out that evolution. JP: Exactly. Biology. That’s part of the beauty of it. NF: Nature carried out that entire process for us. NF: Joana, since these medicines are created from living organisms, can we say they are, in a way, more “intelligent” and have greater therapeutic potential? Joana Cristóvão (JC): In some cases, they do have tremendous therapeutic potential. One of the advantages of these molecules is their remarkable specificity. You can think of it as a key fitting into a lock. It has to be the right key. Biologics, because they speak the same biological language as our bodies, have this advantage. However, that does not mean they are better than small molecules. It means that, because they are produced by living microorganisms, they are highly complex and would be very difficult, and in some cases impossible, to produce through traditional chemical synthesis. Their great strength lies in their specificity. Examples of biologics include proteins that facilitate communication within the body and monoclonal antibodies that identify specific targets. These functions are particularly suited to biologics and less common among small molecules. NF: João, as I understand it, this is still an emerging field worldwide. How did Hovione, a company historically linked to chemical synthesis and small-molecule particle engineering, decide to embrace the challenge of biologics? JP: Honestly, it has been a very natural transition. Over the years, Hovione has developed highly specialized expertise in chemistry, particle engineering, and formulation science. When we look at biologics, despite their greater complexity, the underlying challenge is very similar. These medicines still require materials, processes, and controls to ensure they reach patients safely, consistently, and effectively. NF: But is there real potential? JP: Absolutely. Not only is there potential, but there are also significant challenges. This leads to the second point: curiosity. Throughout Hovione’s history, starting with our founder, there has always been a drive to embrace increasingly complex challenges. That curiosity is part of our DNA, particularly within our Innovation and Development Center. It is also one of the most rewarding aspects of working at Hovione: being part of this transition. NF: And it is not that far removed from Hovione’s history either. JP: Exactly. NF: Joana, in which therapeutic areas have biologics already had the greatest impact? Are there diseases where they have clearly transformed patient treatment? JC: There are several areas. NF: So this is no longer science fiction. It already exists in practice. JC: Exactly, and it has existed for quite some time in some fields. In oncology, for example, antibodies are used to target and kill cancer cells with high specificity. Instead of attacking cells broadly, these treatments target the disease’s underlying mechanisms. NF: Which I assume reduces side effects. JC: It does. Cancer is also a very clever disease. It evolves rapidly and often hides from our immune system. There are biologic therapies designed to help our natural defenses do their job by removing the “invisible cloak” that some tumors use to evade detection and progress rapidly. Another classic example is diabetes. Insulin has been the most common treatment for diabetes for decades. Before biotechnology, insulin was extracted from animals, making production limited. With biotechnology, we gained the ability to produce human insulin, known as recombinant insulin, using living microorganisms. This transformation made the treatment available to far more people and has saved countless lives. NF: Two clear examples where biologics are already making a difference. João, these medicines are on the market today, but I imagine developing and stabilizing them in the laboratory presents major technical challenges. What are they? JP: Because these molecules are highly complex and, as Joana described, quite elegant, they are also extremely sensitive, almost like greenhouse flowers. Biological evolution has optimized them to survive under very specific conditions, conditions that often do not exist during manufacturing, transportation, or administration. As a result, they are highly sensitive to heat, air, pressure, and even prolonged contact with one another. When these molecules interact too much, they can lose their structure and unfortunately their therapeutic effect as well. This is where we come in. Clients often approach us with molecules that have tremendous therapeutic potential but are still only proof-of-concept projects. Our role is to take those early experimental results and develop the controls, processes, and formulations needed to scale production to thousands or even millions of doses while maintaining impeccable quality and stability. NF: Joana, how are these medicines administered? Are they different from conventional drugs? Traditionally, many biologics require intravenous administration in a hospital setting. Is that still the case? JC: Traditionally, yes. Most biologics are administered directly into a vein through an infusion, similar to receiving an IV drip. However, the pharmaceutical industry is not only focused on treating diseases. It is also increasingly focused on the patient experience. These treatments require hospital visits and can take time to administer. For chronic illnesses, this process repeats throughout a patient's life. The industry's goal is to develop alternative treatments that are more comfortable and give patients greater independence. NF: So they would no longer need to go to the hospital. JC: Exactly. The ultimate objective is to create injectable solutions that patients can administer themselves. Achieving this requires innovation in technology, formulation development, and medical devices. NF: João, this is where high-concentration formulations come in. What does that mean in practice? Could we eventually administer these medicines ourselves without the help of a nurse? JP: We certainly hope so. The concept of high-concentration formulations is relatively simple: fitting as much medicine as possible into the smallest possible volume. Ideally, that volume is small enough to fit into something like an auto-injector that can be carried in a pocket. NF: A pen-like device. JP: Exactly, a pen. Thanks to newer treatments, particularly in areas such as obesity, these devices have become much more familiar to the public. Technically, it sounds simple: more medicine, less liquid. But as we discussed earlier, these molecules are highly sensitive. As concentration increases and the molecules become more crowded together, challenges emerge. In addition to stability concerns, there is the issue of viscosity. This is easy to visualize: the more concentrated something is, the thicker it becomes. NF: Which makes it harder to inject. JP: Exactly. And greater viscosity generally means greater pain during administration. That directly contradicts the goal of developing treatments that are more convenient and patient-friendly. This is one of the major challenges facing the industry today: finding ways to overcome dose limitations and reduce administration volumes without compromising therapeutic effectiveness, convenience, or patient acceptance. NF: Joana, before we finish, what do scientists feel when they look toward the future and see Hovione’s work helping bring medicine closer to solutions that are increasingly personalized, convenient, patient-centered, and comfortable? JC: I think it is a tremendous responsibility, and that responsibility is also a major source of motivation. Medicine is becoming increasingly personalized and focused on the biological mechanisms that cause disease rather than simply treating symptoms. It is incredibly rewarding to be part of teams contributing to this journey toward a better future, one that places patients at the center. NF: João, is the future biological? JP: Not exclusively, but certainly in part. Biologics allow us to dream bigger. They open the door to better, more personalized, and more effective medicines, creating possibilities that were difficult to imagine until now. NF: João Pires and Joana Cristóvão, thank you for opening the doors to the future of medicine. With this look toward tomorrow, we conclude the first season of The Next Discovery. Over the course of six episodes, we traveled from a basement laboratory in Lisbon in 1959 to global technological leadership that now touches the lives of more than 80 million people every year. These conversations have shown that with curiosity, rigor, and talent, the next great scientific breakthroughs can indeed bear the signature of our country. To listen to all episodes of this series, visit observador.pt or your favorite podcast platforms. Until the next discovery.

Article
Observador Lab, 23 julho 2026

Podcast “The Next Discovery” (EP6) - High-Dose Biologics: From Fiction to Reality

Jul 23, 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 asthma to therapies that may one day reach the brain, we follow Hovione’s journey in respiratory and nasal drug delivery, where every particle is engineered to improve patients’ lives. 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 fifth episode of the podcast here, featuring Eunice Costa, Director of Research and Development Center 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 where we open the doors to science and innovation with global impact. I’m Nelson Ferreira, and today we’ll explore how the respiratory system and the nasal route are being used to deliver medicines throughout the body in fast and innovative ways. Joining us is Eunice Costa, Director at Hovione’s Research and Development Center. NF: Hello, Eunice, and welcome. Hovione’s history is closely linked to the lung. More than two decades ago, you began developing and manufacturing solutions for inhaled medicines. What are the major diseases whose treatment has advanced significantly with the help of these innovations? Eunice Costa (EC): Hello, Nelson. Thank you for the invitation. To begin with, respiratory diseases are among the most prevalent conditions and have a tremendous societal impact. We have asthma and chronic obstructive pulmonary disease, or COPD. The technology required to manage these diseases, from molecule design to formulations and delivery devices, is fundamental to making them manageable. While they certainly have a significant impact on patients’ daily lives, these conditions can be effectively controlled, allowing people to live normal lives. NF: Especially because some of them aren’t curable. EC: Exactly. NF: COPD is one example. EC: That’s right. The medicines available today are primarily aimed at disease management, particularly bronchodilation, keeping the airways open and unobstructed. NF: Is that what an asthma inhaler does? EC: Exactly. That’s what the asthma inhaler does, the device everyone recognizes. It’s probably the most iconic example, and one that we often see used incorrectly in movies. NF: Really? Is it also what we use during a spirometry test? EC: Spirometry is primarily a diagnostic test that measures lung capacity when disease is already present. NF: But an inhaled medication is also used during the procedure, right? EC: Exactly. NF: Today, Hovione is also proud to offer end-to-end solutions for inhaled and nasal medicines, primarily targeting the lungs, as we’ve been discussing. Does that mean you control the entire process, from molecule synthesis all the way to the final inhaler device? EC: Yes, exactly. And the journey has been very gradual and organic, so to speak. If I can make a chemistry joke, “organic” fits quite well. But let’s continue. Hovione started with molecule synthesis, which is part of our history. From there, we specialized in controlling what we call particle size, or particle engineering, because these medicines need to be carefully engineered to be delivered effectively to the lungs. We handle synthesis, though we don’t work in drug discovery itself. We’re not discovering new molecules; rather, we support pharmaceutical companies with synthesis and, in this case, particle engineering, which is critical for inhaled medicines. Next comes combining the active pharmaceutical ingredient with additional components to create a medicine, which is also far from simple. Finally, there’s the inhaler, the medical device people actually see. It’s the engine that generates the aerosol. In the traditional asthma inhaler, which is the best-known example, aerosol generation is active. A pressurized gas propels the medication. In the types of devices we specialize in, known as passive devices, dry powder aerosols are generated using the patient’s own inhalation effort. NF: The patient inhales the powder. EC: Exactly. It’s still a challenge because there needs to be a perfect combination of particle properties, formulation, and device design to create the aerosol and achieve effective deposition in the lungs. We have control over all those aspects. NF: The lung seems like a particularly challenging organ for drug delivery. What makes it so difficult to ensure the medicine reaches exactly where it’s supposed to go? EC: Right. NF: Do you put a GPS on it? EC: Not exactly. That would be nice. The reality is that the lung has evolved over millions of years to prevent the entry of any foreign particle, whether it’s a pathogen, a virus, or anything else. NF: That’s its natural behavior. EC: Exactly, and fortunately for us. The lung is very effective at preventing exposure. It’s often said that if the entire surface of the lungs were spread out, it would be about the size of a tennis court. It’s an enormous surface area. Without defense mechanisms, we would constantly be exposed to harmful particles. Evolution designed the lungs to keep everything out. When we try to use the lungs as a route of administration to treat patients, we have to find ways to navigate around those defense mechanisms. NF: Or trick the lungs. EC: Yes, you could say that. We have to persuade them. The key lies in a magic number: aerosol particle size. Whether it’s a dry powder cloud or a liquid aerosol, the particles need to be between one and five microns in size. We’re talking about particles at least ten times smaller than a human hair. These are extremely fine powders. Very small particles tend to clump together, absorb moisture, and behave unpredictably. First, you have to reduce particle size, then control those behaviors, and finally use a relatively simple device. NF: Of course. EC: A device capable of generating that aerosol. NF: And one that anyone can use. EC: Exactly. NF: I believe Japan crossed paths with Hovione’s story again through the success of Inavir. What is this product, and what impact did it have? EC: Inavir is a story that goes back several years and is very illustrative of Hovione’s role in this specialized pharmaceutical niche. It’s an area that requires a broad set of competencies. For context, Inavir is an antiviral medication used to treat influenza. It’s administered directly to the lungs, which are the entry point for the virus. Hovione was involved in developing both the formulation inside the device and the device itself. The inhaler remains, to this day, the world’s only single-use inhaler. It’s extremely simple because patients using it have the flu. Reusing an inhaler in that situation makes little sense. The goal is to use it once and then discard it. The challenge was developing an inhaler that was cost-effective and sustainable while being designed for a single administration. NF: Use it once and throw it away. EC: Exactly. Since its approval in 2010, it has remained the world’s only single-use inhaler. We can say that millions of people have been treated with a technology developed in Portugal. NF: That’s also a source of national pride. EC: Absolutely. NF: In recent years, the nasal route has generated tremendous scientific interest, particularly because of its potential to reach certain areas of the body, including the brain and central nervous system, more quickly. What makes this route so special? It seems to have no toll booths. EC: Well, there are a few. We still need to bypass the body’s defense mechanisms. The nasal route is fascinating because we often associate anything administered through the nose with allergic rhinitis, pollen allergies, or sinus infections. NF: And allergies in general. EC: Exactly. Conditions that are very localized. But in reality, the nasal cavity offers extremely rapid absorption. Researchers began exploring it as a gateway for treating conditions not necessarily linked to nasal symptoms. Initially, this included areas such as pain management, particularly migraines. More recently, it has also been explored as a potential route to the brain itself. Why? Because our sense of smell originates in the nasal cavity, which contains a network of nerves. NF: Although what allows us to smell is actually in the brain. EC: Exactly. This is one of the few non-invasive routes that provides a relatively direct pathway from the nose to the brain through the olfactory and trigeminal nerves. It opens the door to much more patient-friendly approaches for treating disease. NF: Looking toward the future of healthcare, could nasal delivery eventually replace injections for many therapies? Might we someday say goodbye to needles? EC: Unfortunately, I don’t think so. So many innovative therapies are being developed, and needles and injections remain the most reliable way to ensure delivery, especially for advanced biologic therapies, where administration efficiency must be close to 100%. Everything that is prepared must reach the patient. We’re still far from guaranteeing that level of efficiency through the nose or the lungs. Not yet. NF: Not yet, but there are already significant advantages in certain situations. To bring all these innovations to market, research can’t happen in isolation. Does your team work with scientific and academic partners who accelerate these discoveries? EC: Absolutely. First and foremost, our partnerships with Portuguese universities have been an essential source of talent and knowledge for the advances we’ve made over the years, particularly in respiratory drug delivery. The Faculties of Pharmacy in Lisbon and Coimbra, NOVA University, and Instituto Superior Técnico have all been key partners. Not only academic institutions, but also industry partners. Given the complexity of what we do, multiple disciplines need to come together, from mechanical engineering and physiology to biology. No one achieves major breakthroughs alone. We also collaborate with companies such as Precisepart in Germany in the area of inhaler devices. These partnerships have been absolutely fundamental to our success. NF: Eunice Costa, scientist at Hovione, thank you for helping us understand how science is transforming lung health and how the nasal route is becoming a gateway for medicines that could improve the lives of millions of people. This was the fifth episode of The Next Discovery. Next week, we’ll reach the final chapter of this season and explore what almost sounds like science fiction becoming reality. We’ll discover high-dose biologic medicines and learn how cancer treatments may move from hospitals into our homes. All episodes are available at observador.pt and on major podcast platforms. Until the next discovery.

Article
Observador Lab, 16 July 2026

Podcast “The Next Discovery” (EP5) - Lung and Nasal Delivery: Science That Breathes

Jul 16, 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 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.

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Observador Lab, 9 July 2026

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

Jul 09, 2026

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