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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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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

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Márcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing. The landscape of small molecule manufacturing is rapidly evolving, according to Márcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains. Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs. Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents. Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products. Watch the full video interview or read the transcript at PharmTech.com  

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PharmTech, 6 February 2026

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

Feb 06, 2026

Hovione’s historic site in Loures has been expanded to meet demand and is now operating at full capacity. This Lisbon-based flagship company has developed innovative production techniques to serve laboratories around the world On the outskirts of Loures, in the periphery of Lisbon, a maze of multicolored pipes covers the walls of the Hovione factory. This industrial site, where signs warn of an “explosive atmosphere,” houses the production of active pharmaceutical ingredients — the core business of this company with Portuguese origins generating annual revenues of more than half a billion euros. “The products that leave here are shipped to every continent,” explains Diane Villax, the family matriarch. At 91, her voice moves effortlessly between English, French, and Portuguese — a cosmopolitan streak inseparable from the history of Hovione and the Villax family, its founders. The epic began with an exile: that of Ivan Villax in 1948. With a toothbrush in one pocket and his chemistry degree in the other, the 23-year-old anti-communist fled his native Hungary with relatives hunted by the Soviet regime. After a stop in Clermont-Ferrand, he dropped anchor in Lisbon, where he met Diane, from a family of sugar industrialists. One year after their marriage, they co-founded Hovione in 1959 with two other Hungarian refugees. The early days were artisanal: the company’s laboratory was located in the basement of the family home. “One of my earliest childhood memories is of adults in white lab coats. I knew how to use a fire extinguisher at six!” smiles Peter Villax, son of Ivan and Diane, who worked for Hovione for more than thirty years. Very early on, the duo expanded internationally, notably into Japan. The 1980s were prosperous years: growth surged at 20% annually. Then transformation accelerated with the arrival of new technologies in the early 1990s. Today, “the time required to move from test tube to industrial scale has been reduced to a few weeks, compared with six months in the past,” notes Peter Villax. The American adventure Sixty-seven years after its creation, the company — now headquartered in Switzerland — employs 2,400 people. Through medicines incorporating its active ingredients, Hovione claims to treats around an estimated 80 million patients worldwide each year. The Loures site has been expanded, and production has spread to Ireland, the United States, and Macao. The cellar at 1 Travessa do Ferreiro, where the story began, is now a distant memory. Little known to the general public, Hovione is nevertheless a key link in the pharmaceutical value chain: it develops and manufactures molecules for 19 of the world’s 20 largest laboratories. Its expansion has been fueled by favorable market conditions. “Pharmaceutical manufacturers increasingly rely on outsourcing for the production of active ingredients,” notes Loïc Plantevin, a pharma specialist at Bain & Company. “Historically, major groups chose to allocate more capital to research than to manufacturing, while biotech companies — which now drive most of the market’s growth — are not designed to build factories.” Far from resting on its achievements, the company has transformed its offering. “While the founders initially focused on generic active ingredients, Hovione has evolved toward more complex molecules and formulations, produced within exclusive partnerships with its clients,” explains Jean-Luc Herbeaux, a French national and the company’s CEO since 2022. This shift reflects a deeper trend. “For several years now, active ingredients have become a more differentiated market and less sensitive to price,” adds Loïc Plantevin. “Competitiveness is now linked to know-how and advanced production technologies, which require substantial investment.” Hovione is the world champion of spray drying, a technology enabling the production of soluble powders. With the expansion of its New Jersey site, the company aims to double its U.S. capacity — a country that accounts for 60% of its sales. Despite Donald Trump’s attacks on the pharmaceutical sector, which he claims to have brought to heel by forcing price cuts, Hovione remains confident. “We are in the U.S. to grow, and that ambition goes beyond the momentum created by the American administration,” assures Jean-Luc Herbeaux. “Our customers there are asking us to help them produce in the United States over the long term.” Commitment to cutting-edge research and the search for talent are deeply rooted in the company’s DNA. “In his later years, my father collaborated with Nobel Prize–winning chemist Geoffrey Wilkinson. Together, they would go to the Hovione lab to run experiments — just ‘for fun,’ as they put it,” recalls Peter Villax. The group is the largest employer of PhD students in Portugal and has forged partnerships with several national universities. “In some ways, Hovione resembles a university,” he continues. “Despite the sensitive nature of our technologies, we publish many academic research papers.” In search of lost sovereignty To preserve cohesion, the Villax family adheres to strict governance. “Unlike many Portuguese family businesses, most members of the third generation do not work in the company,” notes Duarte Pitta Ferraz of consulting firm Ivens in Porto. “Several independent directors sit on the board. The family’s role is to define values and long-term vision, not to manage day-to-day operations.” This responsibility is fully embraced by Jean-Luc Herbeaux. Since joining the group in 2020 as chief operating officer, sales have doubled. “My priority was to refocus the group,” says the engineer, who previously worked for German chemical giant Evonik. “We developed spray drying, invested in a new tablet-manufacturing process, and increased production speed through a new model that allows our clients to access all our services at a single industrial site.” A member of the European Fine Chemicals Group (EFCG), Hovione is actively defending European pharmaceutical manufacturing — a sector under strain. According to a study by the French Union of Organic Chemical Synthesis Industries (Sicos), Europe’s share of global active ingredient production has fallen from 48% to 30% in ten years, to the benefit of India and China. The reasons include production cost gaps — raw materials, energy — as well as the burden of European administrative and regulatory procedures, explains Maggie Saykali, director at the EFCG. “If we start a price war with our Asian competitors, we will not win it,” she admits. “It is better to compete on quality, innovation, and sovereignty over our value chain.” It took the Covid-19 pandemic and severe shortages for Europe to awaken. Last March, the European Commission proposed legislation on critical medicines. But the race against time has already begun. “China is increasingly using pharmaceutical ingredients as a tool of geopolitical pressure,” warns Maggie Saykali. “It is urgent to preserve European players like Hovione, focused on process innovation — which allows medicines to be produced with higher quality and greater environmental responsibility.” With a new site under construction in Seixal, on the southern bank of the Tagus River, the Lisbon star has not finished shining in the orbit of the global pharmaceutical industry.   (This is a translation from the original article)   Read the original article on lexpress.fr  

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