Press Room

Event

RDD 2026

Start

Sunday, May 10, 2026

End

Thursday, May 14, 2026

Location: Arizona, United States

Booth Number: 5

Hovione will be exhibiting at RDD conference from May 10-14. RDD 2026 is a must-attend international conference covering all aspects of lung and nasal drug delivery. The more than 500 participants will have access to in-depth presentations, workshops, and discussions on cutting-edge science, as well as excellent networking opportunities.

Schedule a meeting. Let’s discuss your project together.

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 faster.

PODIUM PRESENTATION

Translational In Vitro Screening Approach to Support the Development of Dry Powder Inhalation Products by Predicting Clinical Bioavailability

Monday, May 11, 2026 | 2:00 PM

Trailblazers Ballroom

Dina Morais, Ph.D. - Senior Scientist, Inhalation & Advanced Drug Delivery

This work introduces a translational, tiered in vitro and in silico framework designed to support the development of inhaled dry powder formulations by enabling informed ranking of candidates based on more clinically relevant performance attributes.

In contrast to traditional approaches focused primarily on aerodynamic performance, this strategy incorporates mechanistic assessment of key post-deposition processes, including dissolution in biorelevant environments, epithelial permeability, and interactions with alveolar macrophages. Built in line with Quality by Design (QbD) principles and leveraging New Approach Methodologies (NAMs), the platform provides physiologically meaningful data to guide formulation selection and understand performance across different APIs and formulation designs. By capturing the processes that drive absorption and clearance in the lung, the approach enables more informed decision-making in early development. The resulting datasets are structured to support integration into physiologically based pharmacokinetic (PBPK) models and other in silico tools, strengthening the ability to anticipate systemic exposure and bioavailability of inhaled products, and ultimately reducing development risk.

WORKSHOP

Innovative Strategies In Nasal Powder Drug Delivery: Device Design, Advanced Formulations, And Analytical Approaches

Tuesday, May 12, 2026 | 2 – 5 pm

Pathfinders room

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

Dina Morais, Ph.D. - Senior Scientist, Inhalation & Advanced Drug Delivery

In this interactive workshop, we will explore how formulation strategy, particle engineering, device design, and translational in vitro tools work together to enable rapid and reliable nasal drug delivery. Through expert discussion and applied case studies, participants will tackle real‑world uncertainties such as limited data, dose constraints, novel excipients, device development and performance trade‑offs to design fit‑for‑purpose nasal powder products.

Developing a successful nasal powder drug product requires a holistic, end‑to‑end approach, from formulation and particle engineering to device development.
Functional screening and characterization are critical to guide excipient selection, particle design, and performance optimization early on
Translational in vitro tools enable data‑driven decisions and risk‑based decisions.

POSTERS

Posters will be available for viewing between 10am-7pm | Kierland Ballroom

Advancing Nasal Powder Delivery: A Structured Evolution of Device Performance

Ângelo Araujo, PhD - Senior Scientist, Mechanical Engineering and Product Design

Cláudia Costa, PhD - Analytical Scientist, Advanced Analytical Characterization

Brief abstract

This work presents the structured development of a single-use nasal powder device, correlating key design features with emitted dose and intranasal deposition performance. An iterative, data-driven approach was applied, progressing from early 3D-printed concepts to a final injection-molded design. Device parameters such as nozzle geometry, spray pattern, plume orientation, air displacement and ergonomics were systematically evaluated using gravimetric emitted dose measurements and an Alberta Idealized Nasal Inlet (AINI). Results demonstrate a progressive reduction in anterior losses and a consistent increase in turbinate and olfactory deposition, together with improved reproducibility. The final prototype achieves a balanced combination of aerodynamic performance, anatomical targeting and user-centered design, providing a robust platform for future in vitro–in vivo correlation and clinical development in nasal and nose-to-brain applications.

Why visit the poster? Learn how systematic nasal device design can reduce anterior losses, improve intranasal targeting, and de-risk your I&N development program.

Evaluation of β-lactoglobulin (Dispersome™) as a Novel Excipient for Pulmonary and Nasal Delivery

Cláudia Costa, PhD - Analytical Scientist, Advanced Analytical Characterization

Brief abstract

Dry powder formulations are a highly promising strategy for targeted drug delivery to the respiratory tract, allowing therapeutic agents to be directed to specific lung regions according to clinical need. However, the currently available excipient portfolio is limited and does not adequately support high-dose delivery, largely due to issues such as particle agglomeration, suboptimal aerosolization, and low bulk density. Dispersome®, a novel excipient platform based on β-lactoglobulin (BLG), was originally developed as a solubility-enhancing carrier for oral drug delivery. In this work, it was demonstrated that BLG can also overcome key limitations of conventional respiratory dry powder formulations when co-spray-dried with active pharmaceutical ingredients. Critical parameters influencing respiratory deposition, namely dispersibility, aerodynamic performance, and density, were markedly improved in BLG-based composite particles. Pulmonary formulations incorporating BLG exhibited excellent dispersibility, with fine particle fractions (FPF) reaching up to 90% and tapped densities exceeding 0.4 g/cm³. Compatibility was confirmed with active pharmaceutical ingredients such as fluticasone furoate (FF), yielding stable solid dispersions with drug loadings up to 75% w/w. Pulmonary delivery was further demonstrated with a therapeutic dose equivalent to the commercial benchmark (1.6% w/w), achieving FPF ≥ 80%, which is four-fold higher than the benchmark FF formulation. In addition, BLG enabled effective nasal delivery, with targeted deposition in the turbinates (~60%) and minimal off-target exposure. Collectively, these results support BLG as a versatile excipient for both inhalation and nasal drug delivery, particularly for high-dose applications.

Why visit the poster? Learn why BLG emerged as a novel excipient with desirable aerosolization for both lung and nasal delivery, with formulation flexibility enabling deposition to be tailored to the target site.

Critical Quality Attribute-Driven Calu-3 Air-Liquid Interface Model for Comparative Permeability Screening of Dry Powder and Liquid Formulation

Beatriz Gamelas - R&D Analytical Development, Ph.D. Candidate

Dina Morais, Ph.D. - Senior Scientist, Inhalation & Advanced Drug Delivery

Brief abstract

This work presents a Critical Quality Attribute (CQA)-driven in vitro air–liquid interface (ALI) model developed to ensure robust and reproducible permeability assessment of inhaled formulations. Key CQAs, were defined to guarantee consistent epithelial barrier integrity before formulation testing. Using this optimized model, the permeability of tobramycin was evaluated following both dry powder deposition and conventional liquid dosing. The results demonstrate that physiologically relevant powder exposure under ALI conditions enhances the ability to discriminate between formulations compared to traditional

liquid-dosing methods. These findings support the use of CQA-controlled ALI models as reliable early-stage screening tools for inhaled drug development.

Why visit the poster? Learn how a CQA-controlled ALI model combined with dry powder exposure can improve the predictive power of permeability screening and better inform inhaled formulation development decisions.

Book a meeting with our experts

Find out more about Inhalation and Nasal at Hovione

Also in the Press Room

See All

The investment includes both continuous and batch tableting capabilities, as well as connect spray drying with tablet production at its East Windsor campus. Hovione, a Portugal-based contract development and manufacturing organization (CDMO), plans to install a continuous tableting line at its East Windsor, New Jersey campus, adding drug product manufacturing capacity and an integrated pathway from amorphous solid dispersion production through commercial tablet manufacturing. The $35 million investment will bring the first ConsiGma CDC Flex system to Hovione’s recently opened 89 Twin Rivers facility. The line is expected to be commissioned in late 2027 and will support both continuous and batch operation at throughputs ranging from 1 to 200 kilograms per hour, according to the announcement. The system will allow customers to use the same equipment for development, clinical, and commercial production, with formulation development possible using as little as 1.5 kilograms of material. Hovione said the line will also be equipped for containment to 1 microgram per cubic meter to support the handling of highly potent compounds. The new capability will also connect Hovione’s spray-drying operations with tablet manufacturing at the East Windsor campus. The company recently opened a 31,000-square-foot facility at the campus with two commercial-scale spray dryers for manufacturing amorphous solid dispersions (ASDs), completing a $100 million investment in its New Jersey operations. Hovione said the integrated setup will allow customers to move from formulation and particle engineering through tablet production under one quality system, reducing technology transfer requirements and eliminating traditional scale-up between development and commercial production. The ConsiGma CDC Flex platform was jointly developed with GEA as part of a collaboration that began in 2022, the company said. The system incorporates automated process controls and process analytical technology for real-time monitoring during production. Hovione already operates continuous tableting technology at its Loures, Portugal site. In August, the company completed a more than €40 million expansion of its tablet development and manufacturing center there, adding a second commercial-scale tableting line and increasing the center's manufacturing area by 25%. The East Windsor installation will extend Hovione’s continuous tableting capabilities to the U.S. and expand its integrated drug development and manufacturing services for oral solid dosage products. Read the full article at Pharma Manufacturing

Press Clipping

Pharma Manufacturing, 6 October 2026

Hovione to add $35M continuous tableting line at New Jersey site

Oct 06, 2026

Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world’s first ConsiGma CDC flex – a next generation continuous tableting line – at its East Windsor, New Jersey (USA) campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione’s recently opened facility, expanding the company’s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the US. CDC ConsiGma flex system The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. The new flex will operate in continuous or batch modes across a very broad throughput range (from one to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialised design within the flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 µg/m³, supporting highly potent compounds. Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients (APIs) are priorities. Inline process analytical technology (PAT) and automated controls also provide real-time quality monitoring. In parallel, the 2022 adoption of ICH Q13 regulatory framework, guidance specifically for continuous manufacturing of drug substances and drug products, provides harmonisation across the US, Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the US Food and Drug Administration (FDA) alone. Developed jointly with GEA, the ConsiGma CDC flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these innovative developments simplify operation, improve efficiency and containment, and enhance operator safety. Read the full article at Pharma Press UK

Press Clipping

Pharma Press Global, 6 October 2026

Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US

Oct 06, 2026

Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization. Read the full article at PharmTech.com

Press Clipping

PharmTech, 5 October 2026