Press Room

Event

AAPS 2024 PharmSci 360

Start
Sunday, October 20, 2024
End
Wednesday, October 23, 2024
Location: Salt Lake City, United States
Booth Number: 1939
Hovione is present at AAPS in October 2024, know more about the event and contact us to schedule a meeting

Visit Hovione’s booth at AAPS PharmSci 360 next October 20-23 in Salt Lake City and meet our team of experts.

The AAPS PharmSci 360 Annual Meeting is organized by the American Association of Pharmaceutical Scientists (AAPS). The event provides a platform for pharmaceutical scientists from academia, industry, government, and other institutions worldwide to exchange knowledge and discuss the latest advancements in the field.

Don't miss our experts' presentations in Salt Lake City

Oral Presentation, 155 F

Development of Spray Drying Processes Grounded on Innovative Approaches

Monday, October 21 | 10:30 AM – 11:00 AM

Presenting Author: Clara Sa Couto, Ph.D.

Short description: New BCS Class 2 drugs represent up to 70% of the pharmaceutical pipeline. Limited aqueous solubility has been one of the major hurdles in the development of oral-dosage forms, as poor solubility hinders oral bioavailability. Different formulation strategies and enabling technologies have been used to overcome low aqueous solubility, including complexation with other compounds, nano-milling and amorphous solid dispersions (ASD).

ASDs have emerged has one of the preferred methods to improve solubility, with industrially demonstrated processes and multiple approved treatments. Generally, the ASDs manufacturing methods are classified into solvent-based – spray drying (SD), electrospraying, rotary evaporation – and melting or fusion – hot-melt extrusion, KinetiSol, Three-dimensional (3D) printing.

The selection of the most suitable method depends on the nature of the API and the SD has been unanimously recognized as the leading technology due to not only the mild processing conditions but also due to scalability, commercial scale representative ASD material can be produced in laboratorial scale and kept across scales. (full description)

Key learnings:

  • Develop a robust process at lab scale and assure a successful scale-up
  • Understand how to use of mathematical models, rheological and analytical characterization, and PAT tools to improve SD process development
  • Understand how to use a Model Based Methodology to Establish the Design Space and a Commercial Process

Rapid Fire Presentation, 155 E

Streamlining Loss-in-Weight Feeding Process Development Using Predictive Tools

Monday, October 21 | 3:30 PM – 4:30 PM

Presenting Author: João Henriques, M.Sc.

Short description: Continuous Direct Compression (CDC) has gained increased attention due to its advantages over batch processing. In CDC, each material is individually fed into the system at a predefined rate via loss-in-weight feeders, making it essential to understand their behavior during processing. This study aimed to predict the feeding performance and ideal setup for a new material, based on material properties. This was achieved by correlating material properties and feeder setup with feeding performance. A wide range of materials, including excipients, APIs, and spray-dried excipients, were physically and rheologically characterized, and their feeding performance evaluated. Results indicate that feeding performance is predominantly influenced by variables related to density, cohesion, and flowability, which can be obtained by performing three characterization analyses. In turn, these properties determine how different setup options influence feeding behavior. This workflow allows a data-driven approach, significantly reducing the time and material spent on process development.

Key learning: In this presentation, attendees will explore the potential of using predictive strategies to develop and optimize a loss-in-weight feeding process for continuous tableting using minimum analytical and rheological characterization.

 

Join Hovione at our poster presentations

Dispersome® as an Advanced Platform for Oral Bioenhancement

Monday, October 21 | 12:30 PM – 1:30 PM

Authors: Ana Filipa Ferreira Ph.D., Liliana Rodrigues Ph.D., Carolina Pinheiro Ph.D., Maria Paisana Ph.D., Emmanuel Heinrich Ph.D., Ines Ramos Ph.D., Sara Pinto M.Sc.

Presenting Author: João Henriques, M.Sc.

Improving Lipid Nanoparticles Stability for mRNA Lung Delivery Through Nebulization

Tuesday, October 22 | 9:30 AM – 10:30 AM

Authors: Ricardo Miguel Velez M.Sc., Eunice Costa Ph.D., Susana Saldanha M.Sc., Rute Mota M.Sc., Luís Marques Ph.D.

Presenting Author: Eunice Costa Ph.D.

Natural-Based ASD Platforms: Enhancing Stability and Bioavailability

Tuesday, October 22 | 9:30 AM – 10:30 AM

Authors: Francisco Tavares M.Sc., Clara Sa Couto Ph.D., Joana Cotrim B.Sc., Ines Ramos Ph.D., Vanda Serra Ph.D., Maria Paisana Ph.D.

Presenting Author: Clara Sa Couto, Ph.D.

Protein Stabilization Sweet Spot: Novel Class of Sugar-Based Excipients Enabling Downstream Processing and Formulation

Tuesday, October 22 | 12:30 PM – 1:30 PM

Authors: Paulo Roque Lino, Eva C. Lourenço, Joana Diogo, Ricardo Gonçalves, Osvaldo S. Ascenso, Joana Cristóvão, Ana Filipa Ferreira, Luís Marques Ph.D.

Presenting Author: Eunice Costa Ph.D.



 

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Drug Substance at Hovione

Your partner in custom development and manufacturing of APIs.

The Leader in Spray Drying

Know how to overcome your solubility issues with the best scale-up science.

The Future is Continuous

Meet our experts and find out if Continuous Tableting is right for your product.

Industrialization of Innovative Platforms

Learn more about our Large-scale GMP-compliant platforms that support your project from development to commercialization. 

 



 

Also in the Press Room

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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 

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

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

Oct 05, 2026

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