Press Room

Event

RDD 2024

Start

Sunday, May 05, 2024

End

Thursday, May 09, 2024

Location: Arizona, United States

Booth Number: 22

Hovione will be exhibiting at RDD conference from May 5-9. Don’t miss the chance to speak with our experts and learn how our development and manufacturing services for inhalation and nasal - integrated on a single site - can support in bringing your product to market.

We are centrally located between the 'Inspiring Dry Powder Inhalation' and 'Nasal Spotlight' Knowledge Space areas.

HOVIONE WORKSHOP

Nasal Powders: Enhancing Formulation and Device Synergy

May 7th from 2:00 PM to 6:00 PM

Presenters: Dina Morais, Ph.D. - R&D Senior Scientist, Inhalation and Advanced Drug Delivery

Cláudia Costa, Ph.D. - R&D Scientist, Advanced Analytical Characterization

Access the recorded session here

(Gated content. Registration is required.)

Short description: This workshop will address the complexities of formulating nasal powders including achieving the right balance between drug solubility, bioavailability, and delivery by exploring Hovione´s nasal toolbox for formulation strategies and advanced analytical characterization, within the current regulatory framework. The selection of appropriate excipients and manufacturing technologies as well as control over critical process parameters are key factors during product development. The formulation-device dependency when developing nasal products will also be highlighted, focusing on case studies using the new Hovione nasal device.

Key learning: 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.

HOVIONE POSTERS

"Systemic Nasal Absorption of Amorphous Solid Dispersions: Supersaturating Systems for Fast Onset of Action of Poorly Soluble Drugs Through the Nasal Mucosa"

Authors: Patricia Henriques, Dina Morais, Slavomíra Doktorovová, Ana Fortuna

Presenter: Dina Morais, Ph.D. - R&D Senior Scientist, Inhalation and Advanced Drug Delivery

Poster brief description: The poster shows the potential of amorphous solid dispersions for nasal delivery of a poorly soluble drug, through in vitro, ex vivo and in vivo studies.

Key Learning: Supersaturating systems promote nasal absorption of poorly soluble drugs, leading to faster onset of action. In vitro dissolution and ex vivo permeation methodologies are valuable tools for selecting the best formulations prototypes.

"Drug Load Influence on Aerodynamic Properties of High Dosage DPIs: A Case Study of an Aminoglycoside Model Drug"

Authors: João Pires, Maria Inês Lopes

Presenter: João Pires, Ph.D. - R&D Manager, Inhalation and Advanced Drug Development

Brief description: The study assessed the influence of the drug load on both primary aerodynamic distributions, measured online in the spray-drying process, and the final in vitro performance of carrier-free DPI formulations.

Key Learning: The aerodynamic size measurement during the spray-drying process allows the rapid screening of viable formulation candidates, enabling a more straightforward DPI development process.

"Differential Permeability of Dry Solid and Aqueous Suspensions of Fluticasone Propionate through A549 Alveolar Epithelial Cells"

Authors: Alexandre J.S. Ribeiro

Presenter: Alexandre Ribeiro, Ph.D. - R&D Principal Analytical Scientist, Analytical Development

Short description: Determining the lung permeability of orally inhaled drug products with in vitro cell-based platforms has high potential to predict their bioavailability during preclinical studies and increase the success rate of drug development. Cellular platforms used in permeability studies aim to recreate the pulmonary epithelial air-liquid interface barrier, where an inhalable product is deposited onto its apical side and then permeated through a polarized and tight epithelium into its basolateral side. A dry powder fluticasone propionate inhalable formulation was deposited in powder form or suspended in a cellular buffer solution on the apical side of an epithelial culture to investigate differences in permeability related with these different approaches for delivering inhalable formulations onto epithelial air-liquid interfaces.

Key learning: By investigating optimal conditions to estimate the permeability of inhalable products, Hovione is establishing standards for improving formulation screening with these techniques in the early phases of drug development.

"Understanding Leucine Encapsulation in Dry Powder Inhaler Microparticles via Surface Characterization Techniques"

Authors: Lídia Santos, Cláudia Costa

Presenter: Cláudia Costa, Ph.D. - R&D Scientist, Advanced Analytical Characterization

Poster brief description: Encapsulation in the DPI formulations were evaluated using specified surface characterization techniques, XPS, IGC and SEM. For XPS analysis the sample preparation and method conditions were previously assessed to assure repeatable and accurate results. The combination of the 3 techniques revealed good insights into the surface composition, shape, and structure of the composite particles. The differences in solubility and molecular structure of the APIs enabled a better understanding of the encapsulation behavior of leucine.

Key Learning: Deep lung delivery of DPI formulations is highly impacted by the cohesion forces between particles. An extensive characterization of the encapsulation process is imperative to achieve a reproducible and repeatable process with good aerosolization performance.

HOVIONE ARTICLE - ONdrugDELIVERY

Title: High-dose Delivery Platform For Crystalline DPIs

Authors: Susana Saldanha, Lídia Santos, Rui Churro

Source: OnDrugDelivery, 23 April 2024

Abstract: Respiratory drug delivery has diversified the pipeline and portfolio of diseases that can be treated through this route, including already approved anti-infective medicines for cystic fibrosis or influenza patients, and others in development for pulmonary arterial hypertension, idiopathic pulmonary fibrosis and other rare lung diseases. Also, the doses and molecules delivered to the lungs have increased in the last years from a few micrograms to milligrams. This growth in the delivery of high doses has been observed in pharmaceutical compounds, such as antibiotics, vaccines, proteins and peptides, as well as for the treatment of acute emergency indications via the inhalation route.

Read the full article here

Schedule a meeting with our team and get to know more about our unique range of particle engineering technologies for Inhalation & Nasal such as jet milling, wet milling and spray drying.

Let’s discuss your project together.

Find more about RDD2024

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The CDMO is preparing for its New Jersey facility to become fully operational this year. Hovione’s multimillion-dollar investment in expanding its East Windsor, NJ manufacturing site is quickly coming to fruition. Contract Pharma will be visiting the site later in April 2026 to provide a unique overview of what’s new. As a preview, the Contract Pharma team met with Hovione at the Drug, Chemical & Associated Technologies Association (DCAT) Week. David Basile, Vice President of Technical Operations—Americas, spoke at the opening Member Company Announcement Forum on March 23, 2026. In this interview, Basile expands on his remarks at the Announcement Forum. As he explains, Hovione is concentrating not only on New Jersey, but also on facilities in Ireland and Portugal. Contract Pharma: Good manufacturing practice (GMP) operations will soon be fully operational at the New Jersey facility. How has Hovione progressed through this process since the initial investment cycle was announced last fall—or even prior? David Basile: It’s been a really great journey and evolution over the last two to three years, conceiving the plan to grow our U.S. footprint. It was one of the reasons I came aboard with Hovione, to grow that footprint and build our commercial manufacturing prowess in the States. In New Jersey, we had originated [the site] as a tech transfer center. [But] we wanted to grow the organization to be more equivalent with our Portugal and Ireland sites, to do more large-scale manufacturing. So, this is part of that journey. And that’s not just bricks-and-mortar and machinery. It’s been people, talent, partnerships with clients, supporting functions such as QC [quality control] and analytical development. We’re growing our R&D teams as well. It’s a comprehensive approach to systems, people, and processes. CP: At the Member Company Announcement Forum, you ran through some of the major technical specifications of the NJ expansion. Can you talk about a few of the highlights and their capabilities? Basile: This year we’ll be starting up two PSD-3 scale spray dryers. This is a useful scale of machinery for our clients. It plays nicely between the PSD-2 and PSD-4 scales that we have elsewhere in the network. I’d say it’s medium-to-large scale capacity; we could do 30 metric tons annually out of this type of a unit. Product to product, that differs, but we do have products that put that kind of volume out in a PSD-3, so it’s not small-scale. Customers want to hear this because [they want to gain] efficiency with their batch size, and turnaround time. And when we campaign, we can really see significant throughput with this line up of new machinery and assets. The first machine that we will start up is a Hastelloy unit, which is unique. We took a pause [in the construction timeline] to make that upgrade, as we had a client that needed this configuration. There are additional clients that are interested in it too, because you can do acidic solutions and more aggressive kinds of formulations as well as solvent-based formulations. So that’s a unique element of that first machine. The second machine is being qualified later this year. Kind of a twin, but this one is standard 316 stainless steel. CP: When a company brings a new or expanded facility online, new personnel often accompanies the new tech. What is the workforce addition that you expect, and what are the challenges of retaining top talent? Basile: In preparation for commissioning and startup of this new equipment, we’ve already ramped our headcount up, to be ready for GMP launch. We’ve added roughly 20 employees in preparation for this first machine to go [live]. Over the next 18-plus months, we could see something on a similar scale, getting us up to that 40–50 headcount range for that facility once it’s fully operational—and more later on in 2028, when we bring in the CDC [continuous direct compression] Flex unit. That’s what’s really going to be transformative about this new facility: that integrated offering coming to life. CP: Even if the NJ facility is top of mind right now, let’s also touch on some of your plans in Europe. What is your vision for expanding in Europe in the next two to three years? Basile: Ideally, Hovione’s aim is to build an equivalent manufacturing network, where clients can go to any site across the globe and get a similar breadth and scale of offering. We’re doing that now in Ireland, expanding our PSD-4 scale spray drying. One unit was recently installed. Late last year, it went live. Then there’s at least one other new PSD-4 in motion, which is really exciting, because [spray dryers] at this site were historically [exclusive to] larger chemistry manufacturing for API [active pharmaceutical ingredient] synthesis. So now, they’re further building their muscle with additional large scale spray drying capacity. On the Portugal side, there’s a lot of great things going on. Our Tejo campus, in Seixal, Portugal, is a massive, 4.5-million-square-foot plot of land, and there’s a new, modular facility going up there. It’s incredibly exciting. The design of the facility has been well-thought through with material flows [and] gravity-fed processes. Here, we minimize handling and [maximize] speed of processing. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets within each unit. So, why is that relevant? Because we can easily scale the number of fingers. When customers say, “we need more capacity,” we have the design on the table ready to go. We know how to execute, we know how to build and implement our technology platforms in a short timeframe. Deployment timeframes are truly becoming more and more relevant to our clients. CP: From last year’s DCAT Week to this year’s, what conversations are you having with industry colleagues about ever-changing geopolitics? Basile: We’re seeing that local, regional manufacturing capacity is vital. The concept of U.S. for U.S. and China for China seems to be a common theme that our clients are talking about. We happen to have an edge, as we [have already] started our journey of expanding our domestic U.S. capacity. So I think that’s a crucial piece to the puzzle, having dual-sided Atlantic manufacturing operations. The traditional global supply chain model is being challenged. Having soup-to-nuts sites that are fully autonomous in development, scale-up, tech transfer, all the way to commercial scale operation, is vital to Hovione, and how we’re protecting our supply chain. [Concerning] starting raw materials and Tier 2 suppliers, our procurement teams are out in the market making sure that there’s no single point of failure for critical materials [like] polymers and solvents that we utilize. We’re managing and mitigating risk by looking at those secondary suppliers across different geographies. CP: Encapsulating your planned expansions on both sides of the Atlantic, how would you sum up the value to the customer? Basile: It’s about speed-to-market. It’s one partner from early-phase development, clinical scale, all the way through commercial. They gain comfort, trust, and not just capacity and equipment time; it’s also about competency and depth of scientific expertise. We’re not just a traditional CDMO. There’s unique expertise in particle science and spray dried dispersions that we offer our clients that they don’t have. [With] traditional CDMOs, customers typically pay for time in [a particular] unit, for example, they’d say: “I need a machine, and I need [it for] three weeks.” Hovione is truly a partner to our clients. They’re leveraging our platforms, our know-how in spray drying, and our know-how in equipment design. Read the article at ContractPharma.com

Article

Contract Pharma, 6 April 2026

Hovione Eyeing Manufacturing Expansion on Both Sides of Atlantic

Apr 06, 2026

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies. That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month. In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land. Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said. The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility. “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce. Read the full article at FiercePharma.com

Article

Fierce Pharma, 26 March 2026

As expansions come online, CDMO Hovione aims to meet industry's 'dual supply and sourcing' zeal: exec

Mar 26, 2026

Twenty companies presented at the annual kickoff to DCAT Week. The Drug, Chemical & Associated Technologies Association (DCAT) opened DCAT Week 2026 with its Member Company Announcement Forum. The kickoff to the annual event in New York City, underway from March 23–26, 2026, showcased 20 companies. These were selected based on their announcements’ “news priority, criticality, and interest” to DCAT member companies. The following is a summary of highlights from the presentations, supplemented by additional information provided by some of the companies. (...) Hovione Hovione’s Vice President of Technical Operations for the Americas, David Basile, delivered the company’s Member Company Announcement Forum presentation. Basile will be speaking exclusively with Contract Pharma during DCAT Week, so check back for more on Hovione’s latest. Read the full article at ContractPharma.com

Press Clipping

Contract Pharma, 23 March 2026