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Press Release / Nov 11, 2021

Hovione invests $170 million in new capacity and capabilities

Hovione, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives

Jean-Luc and Guy Villax at CPhI Hovione's booth in Milan | Hovione the global leader in spray drying and particle engineering

Jean-Luc Herbeaux, COO, and Guy Villax, CEO at CPhI Worldwide, in Milan.

 

Milan, 10th November, 2021 – Hovione, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives. The company has been on an expansion track since 2016 in Portugal, Ireland and New Jersey with the aim of continuing to increase its capacity and capabilities to address customer needs.

 

The announcement of a $170 million investment in Hovione units in Portugal, Ireland, and New Jersey, leading to a global capacity increase of approximately 25%, was made at CPhI Worldwide, in Milan, by Guy Villax, CEO, and Jean-Luc Herbeaux, COO. 

 

These investments will be used to support growth in the company´s pharma custom development and manufacturing service business, fueled by strongly growing demand for Hovione´s integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. The expansion will go hand-in-hand with a build-up of Hovione´s global team with the creation of more than 300 new jobs globally. This strategy will allow the company to continue to address difficult-to-meet client needs while reinforcing its commitment to the Hovione values and standard of quality.

 

In the USA, Hovione will add a 2900m2 building next to its current facility in East Windsor, New Jersey, laying the foundations for a state-of-the-art Hovione Campus. The upcoming cycle of investment will bring additional commercial spray drying capacity online by 2023. Further investments will follow with the aim to solidify the company´s integrated offer: API - Particle - Drug Product in the region. This expansion will allow Hovione to accompany existing and new customers favoring US-based manufacturing through their development cycles all the way to commercial.

 

The capacity and capabilities of Hovione´s Cork site in the Republic of Ireland will also be upgraded to enable the production of Highly Potent Active Pharmaceutical Ingredients (HPAPI) and to facilitate onboarding of Drug Substance Manufacturing projects of all sizes. The investment will create an ecosystem in which large customer projects with unique technologies can find a home by connecting to the existing infrastructure and equipment. The site will also receive a new commercial size spray dryer to support the growing demand for particle engineering services. 

 

In Portugal, Hovione is ready to start operations of its most recent facility with an increase in chemical synthesis capacity for High Potency Active Pharmaceutical Ingredients (HPAPI). The building is also prepared to receive a new commercial spray dryer to respond to the future needs of the global drug market.

 

“Hovione is in it for life and what better way to manifest this than through expansion of our global capacity and capabilities. Our sustainable organic growth strategy will allow us to keep true to those values that have been guiding us for more than 60 years”, says Guy Villax, Chief Executive Officer.

 

“These investments reinforce our integrated specialized offer globally, providing our clients with a line of sight for their projects. Focus is placed on facilitating and speeding up the drug development cycle and launch, by providing API manufacturing, Particle Engineering and Tableting services in each site. Our strategy continues to be to grow organically via investments in our existing sites, which are designed for purpose. This reduces the complexity associated with the growth journey and allows us to focus our management attention on what counts most, i.e. guaranteeing that our clients go to market with quality, safe and effective medicines for their patients” says Jean-Luc Herbeaux, Hovione’s Chief Operation Officer.

 

About Hovione: Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. In the inhalation area, Hovione is the only independent company offering a complete range of services. Hovione is a company with a culture based on innovation, quality and delivery. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. 

 

 

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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, 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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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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