Press Room

Event

RDD Europe 2023

Start
Tuesday, May 02, 2023 - 09:00
End
Friday, May 05, 2023 - 17:06
Location: Antibes, France
Booth Number: Table #20
Drug Delivery Formulation | Hovione

Hovione will be exhibiting at RDD conference from May 2-5. Don’t miss the chance to speak with our experts in the Inspiring Dry Powder Inhalation Knowledge Space 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.

 

Find us at the Blue Knowledge Space - Inspiring Dry Powder Inhalation - Table #20

 

schedule a meeting
https://www.hovione.com/contact-us

 



 

 

On May 3rd, don’t miss the joint workshop with Hovione and H&T Presspart 

 

Title - “Integrated Development for Capsule-based DPIs - Solving New Challenges”

Presenters: 

  • Susana Saldanha, M.Sc. - R&D Manager, Formulation Development, Hovione
  • João Pereira, M.Sc. - R&D Analytical Development,  Analytical Manager, Hovione
  • Mirjam Kobler Ph.D. -  Global Business Development Manager, H&T Presspart 

Abstract:

This workshop will address the most relevant aspects of DPI development covering formulation to device development, as well as process optimization and analytical characterization.  The most common challenges expected at each stage will also be highlighted. A data-based development approach will be applied using risk analysis and structured experimental design based on various case studies, for different development stages, including process optimization and scale-up activities. Starting with a review on the design and development of a highly efficient capsule-based device, the participants will further learn how to use tools to prepare and design development plans to achieve optimal performance from different formulation strategies to drug-device combinations. Case studies will be presented on the interplay of carrier-based and carrier-free formulations, with a newly designed device. The higher focus will be placed on the hurdles of composite particles formulation and process development as well as capsule filling of said challenging formulations.  Unit operations such as spray drying and capsule filling will be covered during this workshop.

 

On May 4th, don’t miss the POP Session – “Posters on the podium” with Patricia Henriques, M.Sc.

 

Title - Benchmarking of Particle Engineering Strategies for Nasal Powder Delivery: Characterization of Nasal Deposition using the Alberta Idealized Nasal Inlet

 

Abstract:

Powder formulations of a drug and mucoadhesive polymer have increased residence time in the nasal cavity and can be manufactured by blending, spray-drying or agglomeration of primary particles into chimeral agglomerates (CA). While spray-drying allows particle size control and generation of amorphous solid dispersions, blending is simpler and CA should allow faster dissolution after breakup into smaller particles. The objective of this study was to characterize nasal deposition and benchmark nasal powders manufactured by different particle engineering strategies, namely spray dried microparticles (SDM), CA and blends, using the Alberta Idealized Nasal Inlet (AINI). The AINI method conditions were firstly optimized by selecting appropriate angle of actuation and flow rate. Then, six different formulations prepared with distinct polymers and particle engineering strategies were evaluated.

 

On May 5th, don’t miss the Podium Presentation with Eunice Costa R&D Director, Inhalation & Advanced Drug Delivery 

 

Title - “Addressing challenges in high dose dry powder inhalation: formulation and device”

 

Abstract:

High dose delivery to the lungs is gaining momentum to address a diversified array of diseases being treated via respiratory drug delivery, comprising a range of drug classes, spanning from less potent small molecules to biologics. Dry Powder Inhalers (DPI) are the dosage form of choice for delivering high payloads to patients. Still there are opportunities for improvement in terms of ensuring that the formulation addresses the pharmacokinetics needs of the specific drug and indication, in close integration with the device, while ensuring delivery efficiency and safety. 

Herein, different high dose delivery platform approaches are discussed in terms of relative advantages and potential pitfalls, followed by some exemplary case-studies: from small molecules to biologics: development of high dose crystalline formulations and high dose spray dried proteins, as well as implementation of a DPI device suitable for cohesive high dose formulations. 

 

 

Two posters will also be presented:

  • Title - In Vitro Methodologies for the Screening of Nasal Powders: Polymer-based Formulations 

    Presenter: Patricia Henriques, M.Sc. – University of Coimbra, Hovione

     
  • Title - Expediting spray dried DPI formulation via the use of PAT

    Presenter: Maria Inês Lopes, M.Sc. – University of Lisbon, Hovione

 

 

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.

schedule a meeting
https://www.hovione.com/contact-us



 

 

 

 

Schedule a meeting with our experts.

Find more about RDD Europe.

 

 

 

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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  

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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  

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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    

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Contract Pharma, 31 July 2026

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