Press Room

Event

DDL 2023

Start
Wednesday, December 06, 2023
End
Friday, December 08, 2023
Location: Edinburgh, Scotland
Booth Number: #165

Hovione is excited to participate in the DDL Conference 2023 from December 6-8 in Edinburgh. Don't miss the opportunity to engage with our experts in inhalation and nasal drug delivery and discover how our comprehensive expertise and leadership in Particle Engineering can ensure that your inhalation and nasal therapies are engineered for success from start to finish.



Join Hovione's Presentations



On December 7th, don't miss the oral presentations by our experts:

 

Title: "Enhanced Lung Delivery of mRNA Using Nebulized Lipid Nanoparticles"

Ricardo Velez, Associate Scientist, IADD 

Time: 14:40 - 14:55

Description: The current study developed a formulation of lipid nanoparticles (LNPs) that encapsulate either messenger RNA (mRNA) or transfer RNA (tRNA), enabling their delivery into the lungs through nebulization. tRNA-LNPs and mRNA-LNPs were produced using microfluidics, followed by a buffer exchange via dialysis to investigate the effect of different excipients on LNPs colloidal stability during nebulization. The formulation containing PBS and Tween 80 demonstrated the capacity to sustain the colloidal stability of tRNA-LNPs during nebulization. This formulation was then applied to mRNA-LNPs, maintaining particle colloidal stability and mRNA integrity throughout the product's lifecycle. 

The mRNA-LNPs were nebulization using a vibrating mesh nebulizer and produced droplets with favorable aerodynamic characteristics: Median Mass Aerodynamic Diameter (MMAD) of 4.6 µm, a Fine Particle Fraction of Emitted Dose (FPFED) of 51%, and an Emitted Dose (ED) of 92%. By presenting a formulation capable of withstanding mechanical stress induced by a vibrating mesh nebulizer while exhibiting satisfactory aerodynamic performance, this work is a significant advancement in the nebulization of nucleic acids.

 

Title: "Amorphous Spray Dried Microparticles for Nasal Delivery: Tackling Solubility Challenges while Targeting Systemic Nasal Absorption"

Patrícia Henriques, Scientist, Inhalation and Advanced Drug Delivery

Time: 14:55 - 15:10 

Description: Dry powder formulations for nasal drug delivery can be manufactured by spray drying, a technology that allows particle size control and the generation of amorphous solid dispersions for drug solubility enhancement. The objective of this study was to characterize the dissolution and drug release performance of amorphous spray dried microparticles comprising a model poorly soluble drug piroxicam and two different polymers, while comparing with the corresponding physical blends. The lead formulation was further characterized regarding nasal deposition using the Alberta Idealized Nasal Inlet (AINI). Overall, the results show spray drying as an advantageous technology for nasal targeted systemic delivery. Moreover, a combined performance evaluation using dissolution, drug release and nasal deposition methodologies was adequate to characterize and select lead formulation candidates.

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Don't Miss Hovione's Poster Sessions 

Poster Title: High drug load and performance formulation platform for DPI

Susana Saldanha, RD Manager, IADD 



Description: The work developed shows a formulation platform using crystalline active ingredient particles coated with a force control agent, such as Leucine, provides a solution for delivering high drug loads to the lungs by increasing more than 4 times the fine particle fraction (FPF) from 7% to 38% when comparing with the uncoated API particles. The results show that this formulation platform can be applied in a wide range of therapeutic indications that require high drug load inhalable powders. In addition, the combination of the formulation with a high-performance device such as Sunriser®, can further improve the delivered dose efficiency.

Poster Title: "Impact of the blending process of carrier-based formulations on DPI performance" Luis Sousa, Senior Analytical Scientist, AD 

Abstract: This work aimed at investigating the impact of blending process parameters, such as the order of addition of a pre-blend of excipients and the blending energy, on the aerodynamic performance of carrier-based formulations containing magnesium stearate. Several blends were manufactured as part of a DoE and the results revealed that no statistical model could explain the variations observed. Nevertheless, a clear correlation was observed between the API content of the blends and aerodynamic performance (Fine Particle Fraction), which was further explored with the help of thermal analysis (DSC). At the end, optimal blending process conditions were defined for this type of formulations.

 

Schedule a meeting with our team - Booth #165 - and get to know more about our unique and comprehensive expertise in inhalation and nasal drug delivery and how we can support your needs in your drug development and manufacturing.

Let’s discuss your project together.

 

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https://www.hovione.com/contact-us

 

 

 

 

Schedule a meeting with our experts.

Find more about DDL 2023.

 

 

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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

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

Oct 05, 2026

Formulation Development/Drug Product Manufacturing  Hovione Completes $46-M Tablet Mfg Facility Expansion  Hovione, a CDMO of drug substances and drug products, has completed an expansion of its tablet development and manufacturing center at its main global campus in Loures, Portugal, adding 25% more commercial-scale batch tableting capacity for oral solid dosage products. The expansion strengthens integrated manufacture of amorphous solid dispersions by spray drying and tableting at a single site. The recently inaugurated expansion completes an investment cycle of more than EUR 40 million ($46 million).  Hovione expanded its batch tableting capacity by adding an additional line mirroring the original unit across every local operation: dispensing, blending, dry granulation, tableting, and film coating. The mirrored configuration reinforces capacity at the 300 kg to 400 kg batch scale and provides both redundancy and like-for-like product transfers between lines. Supporting areas, including in-process control and staging space sized to the increased production capacity, were also added as part of the expansion.  Read the full article at DCATVCI.org  

Press Clipping
DCAT Value Chain Insights, 3 September 2026

Supplier News: Lonza, Evonik, Hovione, Catalent & More

Sep 03, 2026

The company is building out more than 200,000 square feet of space in New Jersey. In April, Contract Pharma had the opportunity to tour Hovione’s expanded manufacturing facility in East Windsor, NJ. The company is planning a formal ribbon-cutting this fall; before that, we got an inside look at some new features. Having established United States operations in 2002, Hovione now has more than 200,000 square feet of space in New Jersey. This will be developed into a large, integrated campus in the next five to ten years. Overall, the company’s recent NJ expansion, which began in 2025, has tripled its total spray-drying capacity in the U.S. Future Facility Upgrades A 125,000-square-foot greenfield acquired by Hovione at the East Windsor campus will eventually be a large-scale production site. This includes enhanced quality control and R&D capabilities. Together, all this adds to Hovione’s stable of manufacturing sites, R&D centers, and other offices spread across three continents. Key to the expansion is a targeted reduction of Hovione’s carbon footprint by 40% by the year 2030. Part of this goal is embracing new and/or changing solvent types to help meet sustainability standards. Additionally, the company says automation that has been put in place at its Portugal site will be replicated in NJ. Hovione Aligns NJ Operations At the Drug, Chemical & Associated Technologies Association (DCAT) Week in New York in March, Contract Pharma met with Hovione. There, David Basile, Vice President of Technical Operations—Americas, further illustrated the New Jersey expansion. “Hovione aims to build an equivalent manufacturing network, where clients can go to any site across the globe,” Basile said. “The design of the facility has been well-thought through with material flows [and] gravity-fed processes. 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.” Ultimately, with these moves and a strategic partnership model, Hovione aims to provide customers an opportunity to co-invest and access the company’s proprietary knowledge and assets to accelerate programs and create long-term value. Read the full article at ContractPharma.com    

Press Clipping
Contract Pharma, 31 July 2026

Hovione Planning Ribbon-Cutting at NJ Facility – A Behind-the-Scenes Preview

Jul 31, 2026

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