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 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 

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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 

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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  

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Can Continuous Tableting End Scale-Up for Complex Oral Drugs?

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