Press Room

Article / Oct 20, 2020

The Coronavirus Crisis: Challenges and Opportunities for CMOs, CDMOs and CROs

CheManager, 20 October 2020

Experts Share Their Opinions on How the Custom Manufacturing and Research Industry can Tackle the Impact of the Covid-19 Pandemic and a Demanding Economic Climate

20.10.2020 - The coronavirus crisis caused by the Covid-19 pandemic has uncovered problems that have been smoldering beneath the surface of the pharmaceutical industry — including CMOs/CDMOs and CROs — and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

The ongoing pandemic is putting pharmaceutical R&D strategies to the test and also challenging manufacturing planning and supply chain management. Particularly in this industry segment, the supply chain is global, complex and interconnected. Each link must be strong enough to ensure that the road from lab to final drug product is as smooth as possible, even under the most difficult circumstances.

In addition to the pandemic, the growing threat of a no-deal-Brexit amid old and new trade conflicts and increasing protectionism, is putting even more stress on companies operating in the pharma sector.

In cooperation with Wombat Capital*, a cross-border investment bank, CHEManager asked executives and experts of CMOs, CDMOs and CROs operating in the pharmaceutical sector to share their opinion on current challenges for their industry and how these challenges may influence changes in their market and opportunities.

Expert Interview: Jean-Luc Herbeaux

Jean-Luc Herbeaux

CEO

Degree in Mechanical Engineering, Master of Science and PhD in Mechanical Engineering

Jean-Luc Herbeaux studied in France (Diplôme d´Ingénieur from UTC) and in the USA (M.S.and Ph.D. in Mechanical Engineering from the University of Houston).

Jean-Luc Herbeaux started his professional career as Assistant then Associate Professor at the Kanazawa Institute of Technology in Japan.

From 2000 to 2020, Jean-Luc Herbeaux held multiple high-level leadership positions at Evonik, one of the world’s leading specialty chemicals companies, and before joining Hovione, was at the helm of Health Care Business Line of Evonik.

Jean-Luc Herbeaux joined Hovione as Chief Operations Officer in 2020 and was appointed CEO in April 2022.

16.10.2020 - So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

In cooperation with Wombat Capital, a cross-border investment bank, CHEManager asked executives and experts of CMOs, CDMOs and CROs operating in the pharmaceutical sector to share their opinion on current challenges for their industry and how these challenges may influence changes in their market.

What in your opinion and from your perspective are the main impacts of the coronavirus pandemic on the drug supply chains?

Jean-Luc Herbeaux: While Covid-19 placed some strain on global supply chains and logistics, the pharma industry overall showed surprising resilience considering the severity of the situation.

The pandemic highlighted the strong reliance and dependence of drug and medical product supply on China and India and the limitations of such a supply model. It caused governments to look at pharmaceutical manufacturing in a more strategic manner, including potential repatriation, to guarantee access to life-saving medicines to cater to the most extreme demands. A new type of “nationalism” promoting preferential (or even exclusive) access to therapies and vaccines has emerged in the meantime and it has the potential to greatly disrupt the established global manufacturing and supply models.

Many Western CDMOs have already shifted operations back to the USA and Europe as intensive business activity in China has driven up labor costs. In addition, national policies, trade-related developments such as Brexit and the US-China dispute and impacts of pandemics are likely to require repatriation of at least part of the supply chain in many countries. Could CMOs/CDMOs be beneficiaries of restructured supply chains?

J.-L. Herbeaux: CMOs/CDMOs have a chance to benefit from the repatriation trend, which already started some years back. The first wave of relocation, which started some 4 or 5 years ago, stemmed from quality and regulatory considerations. This repatriation was very beneficial to CDMOs with assets and quality systems in good standing as they were able to gain access to business which had escaped them up to that point.

The new wave seems to be driven by countries and their citizens coming to terms with the fact that most of their medical supplies are from foreign countries and entities. The recent Covid-19 crisis has revealed the limits associated with reliance on third party country supplies and the ongoing Covid-19 vaccine and therapy “nationalism” further exacerbated the sentiment that repatriation of pharma assets is now a strategic priority.

We ought to recognize that the Covid-19 pandemic is extreme in terms of impact and medical supply needs. It has overwhelmed the global supply chains in unprecedented ways and no economically sound supply strategy could have prepared us for an event of such global proportion. In these special times, there is a risk of overheating and of wrong capital investment decisions. Investments need to make sense not only for the short term (i.e. in Covid-19 times) but also for the long haul (once the world returns to a more normal reality). In this overheated environment, experienced western CDMO´s with flexible assets and operating models and with meaningful engineering capabilities are probably the best bet for this industry. They know how to ramp up and run assets in an effective and nimble manner and make best use of these assets now and in the future thanks to their ability to accommodate an ever-changing portfolio.

What do you think the impact of the repatriation of the drug supply chain will have on the M&A activity in the CMO/CDMO industry? Do you think that this would create an impact on valuations?

J.-L. Herbeaux: The pharma industry is very likely to weather the Covid-19 crisis better than other sectors and accordingly, one can expect valuation to go up at a time when investors may be looking for safe heavens. The demand-supply balance for M&A candidates in the USA will also drive multiples. One can foresee that the high availability of cash and short-term hype may result in some misguided investment decisions in parties and/or assets, which do not represent mid to long-term value. In the pharma CDMO space, assets are important but not sufficient. The right-to-win stems from established competencies in quality, regulatory and manufacturing service excellence and these attributes take time to develop.

Has the inability to hold face-to-face meetings with prospective clients and conduct client visits to sites affected your new business development since the outbreak of the coronavirus pandemic?

J.-L. Herbeaux: New business development has become more difficult as travel restrictions have curtailed opportunities for face-to-face interactions. Physical closeness is known to help individuals (or groups of individuals) form interpersonal relations and develop trust. Proximity and face-to-face communication are therefore particularly important for first-time interactions. We see this clearly in our commercial activities: it is a lot easier to maintain or even further established relationships than to develop new ones. Add to this the need for pharma companies to audit new partners and you will understand why existing partnerships are preferred to new ones at this moment.

The CMO/CDMO industry has managed to support efforts to develop vaccines and therapeutics for Covid-19 despite already being at a high level of utilization. What made that possible?

J.-L. Herbeaux: From what is published, there is significant cash being deployed to ramp up vaccine production and capacity repurposing or reactivation is also on the agenda. Some of this cash came from governments and public organizations to secure supply.

As for Hovione, we are involved in several steep capacity ramp-up exercises and these have been made possible by very strong partnerships with our clients and suppliers. Everyone understands that these are extraordinary times, and all agree that only shared commitments can result in success. The rest is fueled by a sheer desire to save lives. We push our organizations, systems, and processes to new levels of speed and productivity relying on decades of experience, expertise and best-in-class practices. Under these extreme conditions, CAPEX, resources, and associated capacities are deployed faster and products become available in record time. This is what leading and agile CMOs do for a living: deal with the cross-functional and cross-discipline complexity associated with production ramp-up and compress timelines.

For the biopharma CMO/CDMO industry, the pandemic crisis has created great opportunities. What is your opinion on whether and to what degree the CDMO industry will enjoy long-term benefits from its role in tackling the current crisis?

J.-L. Herbeaux: One may assume that the public opinion of the pharma industry will have improved during the last months and that any company, including CDMOs, which contributed to solving or alleviating the Covid-19 humanitarian crisis, would have a chance to boost its image externally but also with its own staff. There is little which can compete with being a contributor to tackling a global health crisis and saving lives.

Leading CDMOs have certainly showed that they can be trusted and that supply chains supported by CDMOS/CMOs are robust. Moreover, their demonstrated ability to step up and make capacity available on short notice, absorbing much of the complexity associated with reaching new levels of supply, has positioned CDMOs at the core of the industry’s journey to provide therapies and vaccines to billions of individuals. The co-dependence between CDMOs and Pharma companies is stronger than ever, and this should increase the propensity of pharma to outsource.

One of Hovione’s facilities is located in Macau, China. How was the site in particular and your business in China in general affected by the outbreak of the coronavirus pandemic?

J.-L. Herbeaux: Macau is a good example of Hovione’s success in controlling the risks associated with Covid-19. Extensive measures were quickly put in place to protect the team members and to ensure the continuity of our manufacturing operations. Many of the raw materials for Macau come from mainland Chinese suppliers and the site was also able to secure its supply chain. The site was even able to adapt to repair specialized equipment with its own staff as technical visits from suppliers were not possible. Our other sites, which have also been running without interruption or disruption, learned from the Macau response and organization. Best practices were quickly rolled out globally under the leadership of a global task force. All our sites are now operating safely according to this new reality. One of our most important decisions has been to offer free testing to our employees with an elevated risk profile, e.g. as they return from holiday.

The race is on to develop treatments and vaccines against Covid-19, and so is the need to assure supply of these potential drugs and vaccines. Pharma companies are leveraging their internal manufacturing networks but also partnering with CMOs/CDMOs. What supply and manufacturing strategies/alliances are in play?

J.-L. Herbeaux: The Covid-19 pandemic has engendered an all-out search for treatment options. Many hundreds of compounds for prophylactic and therapeutic use have been tested in the race against this deadly disease. No drug candidate or route of administration has been neglected and innovative formulation concepts are given due consideration under the assumption that regulatory authorities will likely grant accelerated approval to treatment options which show positive clinical outcomes.

The patient population is considerable, and the urgency is absolute. The manufacturing capacities for the few treatments that have demonstrated some efficacy (or promise of efficacy) to date are being ramped up to scales and with speeds which transcend anything the industry had seen so far.

Pharma companies have sought the help of their partners to ramp up raw material supply and custom manufacturing services to help them deal with this colossal challenge. In times of pressing requirements, strong partnerships are key and unsurprisingly pharma companies have tended to reach out to their existing partners – especially those who demonstrated the ability to meet complicated supply challenges involving new asset deployment and commissioning. We, at Hovione, are part of this select group of CDMOs working closely with partners on both new formulation concepts and steep upscaling of industrial production capacities.

“Emerging”, “virtual” and other small (bio)pharmaceutical companies are driving the discovery and development of new drugs but are mostly dependent on the availability of financing – which could become more restricted due to the economic downturn cause by the economic and epidemiologic disruptions to the global economy. As emerging biopharma companies are important customers of CMOs/CDMOs, how is this going to affect your business?

J.-L. Herbeaux: As a leading CDMO known for helping pharmaceutical companies of all sizes bring new and off-patent drugs to market, Hovione is of course dependent on the health of the biotech industry and its pipeline. So far, our business has remained extremely vibrant as our customers do not appear to be short of cash and pipeline projects are progressing as per plan. The last 3 years have been good in terms of biotech financing (the biotech sector in NASDAQ is at an all-time high). So, one may contend that biotech companies’ strong cash positions will allow them to weather the storm as long as the crisis does not perdure and investments do not stop abruptly. After a few months of increasing disruptions in clinical trials due to Covid-19, data now suggest that clinical trial disruptions have started to recede. Most trial disruptions appear to be due to suspension of enrollment – not financials.

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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