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Article / Apr 30, 2025

Optimising early-stage drug development with continuous processing

Manufacturing Chemist, 30 April 2025

Pharmaceutical innovators face many challenges when developing new products; as such, getting them to market in a timely, safe and cost-effective way is critical. The use of continuous manufacturing technologies can help to overcome some of the most pressing early-stage obstacles

Improving production methods for generic drugs or extending the lifecycle of existing oral solid dosage (OSD) forms is an integral part of the day-to-day operations of many global pharmaceutical companies. At the same time, when formulating new molecular entities, issues such as reducing the cost-per-tablet, increasing patient safety and optimising the price/performance balance of a new drug are common daily concerns. During the early stages of research and development (R&D), however, the availability of the active pharmaceutical ingredient (API) is limited. As such, there is an absolute requirement for process equipment that can produce just a few hundred grams of finished product to fast-track novel formulations. 

The changing perspectives of regulatory bodies such as the US FDA and EMA now mean that there’s a better way to improve both supply chain efficiency and product throughput. It’s the 21st century, the pharmaceutical industry is less risk-averse these days, and it’s well-known that continuous manufacturing (CM) solutions can accelerate product development, reduce costs, improve operational economics and make production more agile.

CM can accelerate the development of innovative products and increase the quality assurance of existing ones by driving process excellence. It’s a more efficient and flexible technology, offering more consistent and reliable tablet production with the reduced use (and loss) of resources such as precious APIs and raw materials. Additional benefits include less downtime and minimal manual intervention.

 

Introducing ConsiGma®

The ConsiGma® portfolio from GEA Pharma & Healthcare is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can perform the dosing and mixing of raw materials, wet or dry granulation, drying, tableting and quality control, all in one line. And, as it can produce granules continuously, there is no waste during start-up and shutdown and the batch size is determined simply by how long you run the machine. Quality is measured throughout the process and, as such, drastically reduces the cost-per-tablet. The ConsiGma® concept combines Quality by Design (QbD) principles with Design of Experiments (DoE) to explore and optimise a wide range of process parameters with less product in a shorter time frame. 

Dr James (Jim) Holman, Senior Director of Technology Management, Pharma Solids, at GEA, takes up the story: “Our stance with CM is consistent in terms of how we approach both commercial-scale and early development work. We’ve created a range of unit operations or submodules, for example, that are ideal for process or product optimisation studies. For wet granulation, for instance, we have the ConsiGma®-1. You can use the same granulator that you would for a larger-scale machine but simply connect it to a single cell of a six-cell fluid bed system.” He adds: “Our approach to R&D is that we try to scale-out rather than scale-up. Our equipment is specifically designed so that you can process a plug or product key in a very controlled way to limit material usage.” 

Jim can cite a litany of Big Pharma organisations that have “developed molecules on our systems in R&D, subsequently transferred them to production and have now had them approved for sale and use.” He acknowledges that, compared with a traditional production-scale system, there are advantages and disadvantages to consider. But he emphasises: “To support our thinking and what we’ve done, there are a lot of commercial products on the market that were made using GEA CM systems.”

 

The ConsiGma®-1: an integrated R&D solution

Developed as a mobile, plug-and-play laboratory-scale version of the GEA’s continuous tableting platform, the ConsiGma®-1 can convert powders into dry granules and is ideal for small-scale research and development applications. It’s specifically designed for maximum flexibility and simplicity in early formulation development work. And, because of its rapid processing times and ability to run batches of a few hundred grams up to 5 kg or more, it’s ideal for developing formula and process parameters using DoE — which can then be scaled-out to the full-size ConsiGma® wet granulation system. “With ConsiGma®, we can help companies all over the world to maximise their R&D efforts and capitalise on the very worthwhile expenditure by getting first-rate products to market quicker,” notes Jim.

When equipped with the optional fluid bed dryer segment, drying parameters for batch sizes of 500–1500 g can be determined on the ConsiGma®-1. And, because these granulation details can be directly scaled-out to a production model (such as the ConsiGma®-25), which benefits from the same design, there is no scale-up. 

Furthermore, as the retention time of the product in the system is minimal, any change in these parameters is almost immediately visible. This allows for very fast and easy exploration of the design space. The result is a better understanding of both operational capabilities and critical process parameters (CPPs), which ultimately contribute to higher levels of quality assurance and patient safety. 

The ConsiGma®-1 is designed for rapid deployment, will fit into the most compact of laboratories and can be transported easily to wherever it’s needed. Installation only requires electricity and standard utilities such as water and compressed air. The system is conceived to be a “plug-and-play” installation. To enhance the R&D flexibility even further, the ConsiGma®-1 can also be configured for hot melt granulation and/or upgraded for contained processing.

To cite an example, a ConsiGma®-1 unit was recently used to expedite the development process for a new product during in-house trials. Everything was running smoothly during scale-out to a commercial-size line, until one of the raw material sources had to be changed. Anticipating granulation issues due to the changed specifications of the raw material, and with a pending deadline — and not wishing to revert to the ConsiGma®-1 for redevelopment (or to clean another piece of equipment) — it was decided to tackle the issue using the production-scale CM line. Owing to the inherent flexibility of continuous processing and the transferable compatibility of the critical parameters, the correct settings were found in just a few hours using only a limited amount of product. Full production mode could be quickly reinstated with minimal disruption.

The ConsiGma® DC for continuous direct compression is the most recent expansion of GEA's portfolio of cost-effective, compact and high-yield manufacturing systems. By integrating four key technologies — accurate loss-in-weight feeding, continuous blending, tablet compression technology and the online measurement of CQAs (Critical Quality Attributes), it offers a robust and flexible production method for a wide range of products in a small footprint. Of note here is that standalone plant is often used to separately test and optimise the critical unit operations before the entire line is constructed, thereby accelerating the process. This means that each manufacturing step can be enhanced without first having to run or invest in a complete process chain. One company that has benefited from this approach is Hovione, a specialist contract development and manufacturing organisation.

Using a combination of standalone laboratory scale units coupled with process analytical technology (PAT) tools, computational models and powder characterisation equipment, Hovione is developing processes at the R&D scale with minimal material consumption and resources. The standalone dosing and blending unit is equipped with feeders and blenders that are identical to those used in GEA’s GMP Continuous Direct Compression (CDC) lines. Powder characterisation and the use of compaction simulations “close the circle” in terms of connecting the unit operations and allow operators to fully define the process parameters that are used in a digital twin version of the line. João Henriques, R&D Director – Oral Drug Product Development comments: “This integrated platform accelerates process development, helps to optimise formulation and product parameters and improves operational performance. It also enables the seamless scale-out of continuous tableting processes to a GMP line with reduced risk and low API consumption. This methodology has been used to successfully develop and scale-out multiple processes to CDC lines.”

 

Coating covered

Not only does GEA have what Jim calls “grouped unit operations” for applications such as wet granulation —wherein a twin-screw granulator is combined with a single cell fluid bed — standalone systems such as dosing and blending rigs, an independent feeder and/or continuous coaters are also available. In addition, plant for direct compression can also be supplied. The ConsiGma® DC-LB Lines integrate continuous dry blending using linear blenders and tablet compression into one efficient continuous production system. Being able to accommodate differently sized blenders makes it a fully configurable setup.

From an operational perspective, adds Jim, the advantage of the GEA Coater during R&D is that you don’t have to run a full-scale trial with all the associated losses of startup, shutdown, etc. All you need is a 1.5 kg plug and then, to scale-out your production, you just repeat the process. It's the same with wet granulation. Doing so gives you the certainty that you can basically repeat the same operation — or just run it for longer — to achieve commercial levels of production.

Jim suggests that a well-known top-tier pharmaceutical company has recently invested in two ConsiGma®-1 units and coaters and is in the process of replacing their existing batch coating equipment with GEA machinery. “It’s now their default choice of coating technology for R&D,” he says. “With the three sizes of coating pans we offer, you have the option of using 1.5, 3.0 or 6.0 kg samples simply scaling that out.”

 

In conclusion

Shining the spotlight on wet granulation as an example application, many of the most well-known names in the pharmaceutical sector have products on the market that were initially tested on a ConsiGma®-1 unit, subsequently transferred to a larger development and launch rig (DLR) and were then put into commercial production.

Reaping the benefits of grouped unit operations during R&D enables GEA customers to expedite product development, eliminate scale-up and rapidly transfer the manufacturing process to an integrated line. Plus, by producing tablets continuously, “batch sizes” are simply determined by how long you run the machine. 

It’s also helping the pharmaceutical industry to produce higher quality products, enhance drug safety, reduce its industrial footprint and decrease waste, which provides significant advantages to governments, companies and patients alike. Continuous processing is the future of pharmaceutical manufacturing. As Jim will attest, the majority of the top ten pharmaceutical companies have now confirmed that their strategy is to develop both new chemical entities (NCEs) and, when economically and technically viable, also manufacture legacy ethical and generic products using continuous technologies.

 

Read the full article on ManufacturingChemist.com

 

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

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Observador Lab, 9 July 2026

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

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

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Observador Lab, 2 julho 2026

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

Jul 02, 2026

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

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