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

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