Press Room

RDD Europe 2025

Start
Tuesday, May 06, 2025 - 09:00
End
Friday, May 09, 2025 - 18:00
Location: Estoril, Portugal
Booth Number: 23
Hovione is present at RDD 2025 in Portugal | Hovione

Hovione is exhibiting at RDD Europe, a conference that has earned a sustained reputation for impactful, actionable content covering all aspects of drug delivery to the lungs and nose. In-depth presentations and discussions on pioneering science are expected to attract an audience of 500 delegates.

Do not miss the chance to meet our experts at table #23 and attend our podium and poster presentations, and workshop sessions.

Hovione Podium Presentation – May 7 

Title: β-Lactoglobulin - A Novel Excipient for Next Generation Spray-Dried Powder Formulations 
Session: May 7th at 11:30AM
Location: Auditorium

Presenters: Paulo Lino. Ph.D. in Pharmaceutical Sciences. Senior scientist. Inhalation and Advanced Drug Delivery
Moderator: Paul Young, Ph.D., Macquarie University, Sydney, Australia

  • Short description: This study explores the potential of β-lactoglobulin (BLG) isolated from bovine whey as a novel excipient in dry powder formulations for respiratory delivery. BLG formed dispersible and high-density composite particles via spray drying.
  • Key learning: Key findings include
    • i) optimized spray drying conditions to obtain BLG particles with high fine particle fractions up to 90%;
    • ii) demonstrated BLG compatibility with active pharmaceutical ingredients like fluticasone furoate and tobramycin;
    • iii) stabilization of amorphous fluticasone;
    • iv) high nasal deposition of BLG-based formulations
    • v) pulmonary and systemic clearance in rats within 24 hours after being inhaled, with minimal immune responses and no observed toxicity.

Hovione Podium Presentation – May 9 

Title: Leveraging Nasal Powders for Complex Therapeutics and Targeted Delivery
Session: May 9th at 11:00 AM
Location: Auditorium

Presenter: Patricia Henriques Ph.D. Scientist. R&D, Inhalation and Advanced Drug Delivery

  • Short description: This presentation explores the potential of nasal powder delivery as a platform for systemic and targeted administration of complex therapeutics. By leveraging advanced formulation strategies, we address key challenges in delivering poorly soluble small molecules and biopharmaceuticals. The talk will highlight particle engineering approaches for targeted delivery, integration with tailored delivery devices, and insights from the development pipeline, showcasing how these innovations converge to enable effective intranasal therapies.
  • Key learning: Understand how formulation for complex therapeutics influences the performance and clinical potential of effective nasal powder products. Explore how particle engineering and device strategies can be optimized to achieve targeted nasal delivery, enhancing patient compliance and therapeutic outcomes

Hovione Workshop – May 7 

Title: Optimizing Biologics Powder Formulations: Achieving High Drug Load, Stability, and Efficient Inhalation
May 7th from 2:00 PM to 6:00 PM 
Sessions: 2:00-3:00; 3:15-4:15 and 4:30-5:30PM
Location: Level 0 Room D3

Presenters: 
Luís Marques, Senior Scientist – R&D, Inhalation and Advanced Drug Delivery
Filipe Vultos. Ph.D. Senior Scientist II. R&D Analytical Department

  • Short description: Get to know Hovione´s integrated formulation-device solution for nasal powders development and learn how the early-stage in vitro screening may be predictive of the in vivo nasal powder performance.
  • Key learning: Interest in developing biologic drugs for inhalation delivery has surged in recent years, primarily due to the advantages of the inhalation route over the parenteral route, especially for respiratory diseases. The main challenge in developing biologic formulations is maintaining the integrity of the biologic during formulation, manufacturing, storage, and delivery to the patient. Dry powders are preferred for inhalation delivery because they offer greater convenience and stability compared to liquid formulations. However, temperature and shear stress during manufacturing can affect the integrity of biologics. This workshop explores key formulation strategies to overcome these challenges, aiming to achieve dry powder formulations for biologics that not only exhibit good stability but also improved aerosolization performance and high drug loads.

Hovione Posters

Poster P12 - Nasal Spotlight
Title: Characterization Study of Nasal Deposition Targeting the Central Nervous System

  • Authors: Cláudia Sofia de Pina e Costa. Ph.D. Analytical Scientist. Analytical Development
  • Key Learning: Highlight the impact of different formulation particle sizes and nasal casts geometries in the deposition within the nasal cavity of the nasal dry powder

Poster P1 - Bench to Bedside
Title: Distinct Baseline Phenotypical and Functional Properties of Macrophages Derived from Two Different Lots of THP-1 Monocytes for Screening the Effects of Inhalable Drugs

  • Authors: Alexandre Ribeiro. Ph.D. Principal Analytical Scientist. R&D. Hovione. Mykaella Mestre M.Sc. Ph.D. Candidate. R&D. Hovione & IST- University of Lisbon, Ibb
  • Key Learning: Show potential sources of variability in the use of macrophage-like cells derived from THP-1 monocyte as drug development tools. Proposes analyzing cellular properties related to inflammatory function and API uptake as quality standards for these cells

Poster P2 Bench to Bedside
Title: Advancing High-dosage DPI Formulations: Integrating Quality By Design For Optimized Performance

  • Authors: Rui Churro. Ph.D - R&D Manager, Inhalation and Advanced Drug Delivery
  • Key learning: This work successfully integrated advanced modeling and Quality by Design (QbD) principles to optimize dry powder inhaler (DPI) formulations, enhancing process efficiency and product consistency. The development of a leucine "fingerprint" model and empirical tools for composite DPI formulation streamlines development and de-risks scale-up, offering significant business value through reduced R&D timelines, improved product quality, and faster time-to-market for inhalation therapies

Poster P12 Aqueous Agenda
Title: Optimizing Inhalation of a Monoclonal Antibody: Transitioning from Nebulization to a Dry Powder Inhaler

  • Authors: Luís Marques, Senior Scientist – R&D Inhalation and Advanced Drug Delivery

 

Contact our experts today to learn how the Hovione team ensures that your inhalation and nasal therapies are engineered for success from start to finish.  
Let’s discuss your project together. Schedule a meeting today.

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The global inhalation contract development and manufacturing organization (CDMO) market is projected to grow from USD 9.13 billion in 2025 to USD 16.68 billion by 2035, reflecting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases, advancements in inhalation drug delivery technologies, and the rising demand for outsourced manufacturing services in the pharmaceutical industry. The inhalation CDMO market has emerged as a pivotal segment in the pharmaceutical contract development and manufacturing industry. With a rising demand for inhaled therapies for conditions like asthma, COPD, and cystic fibrosis, companies are increasingly outsourcing drug development and production to specialized partners. Inhalation CDMO services cater to both large pharmaceutical corporations and small biotech firms, offering expertise in formulation, device compatibility, regulatory support, and scale-up manufacturing. This market is gaining traction due to the complexity of inhalation drug delivery, which often requires niche technical capabilities and specialized equipment. Outsourcing to an inhalation CDMO allows drug developers to reduce time-to-market while ensuring quality and compliance with global standards. (...) Top Companies Several players dominate the inhalation CDMO market through technological expertise, global reach, and service portfolio diversity: (...) Hovione – Offers particle engineering and inhalation development, with a focus on dry powder inhalers. (...) These companies are continually investing in facilities, talent, and technology to meet evolving customer needs in the inhalation CDMO market.   Read the full article on Pharmiweb.com        

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Inhalation CDMO Market Growth Analysis & Forecast 2025 to 2035

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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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Optimising early-stage drug development with continuous processing

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