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Press Release / Oct 03, 2024

Hovione and Zerion Pharma create joint venture to further expand use of Dispersome® technology

A partnership to accelerate the development of the Dispersome® technology platform and further expand its applicability and reach for increasing the solubility and bioavailability of small drug molecules.

Press Release - Hovione Zerion Joint Venture | Hovione

Lisbon, October 3, 2024 – Hovione Farmaciência, S.A. (“Hovione”) and Zerion Pharma A/S (“Zerion”) today announced that they have expanded their partnership to accelerate the development of the Dispersome® technology platform and further expand its applicability and reach for increasing the solubility and bioavailability of small drug molecules. To this aim, the companies created a joint venture responsible for managing the Dispersome® intellectual property portfolio and allocated market rights to the two partners.

Hovione and Zerion have been co-promoting the Dispersome® technology to clients since the beginning of 2022. Under the extended collaboration, Hovione is granted exclusive global rights to develop and offer the Dispersome® technology for drugs delivered via the respiratory route, a field where Hovione is active today with leading formulation and manufacturing capabilities. Further, Hovione is granted exclusive rights to develop and offer Dispersome® formulations for nutraceutical and medicinal foods products, an area with unmet needs in the area of bioavailability. Hovione is also granted a non-exclusive license to promote the Dispersome® technology for use in Pharmaceutical oral dosage forms for new chemical entities. In return for the grant of rights, Zerion will receive royalties from Hovione’s commercial activities in these fields.

Within the framework of the joint venture, the parties will work closely together to bring the Dispersome® technology to customers as quickly as possible. Arla Foods Ingredients (Denmark) will deliver the pharmaceutical excipient (Lacprodan® BLG-100 Pharma Grade) for the Dispersome® technology, when BLG is accepted as a novel excipient.

“Hovione is thrilled to reinforce its collaboration with Zerion to further accelerate the adoption of Dispersome® in the pharma and nutra markets,” said Jean-Luc Herbeaux, Hovione’s CEO. “The use of Zerion’s Dispersome® Technology has proven to deliver superior solubilization power for both pharma and nutraceutical active ingredients. This highly innovative platform is a valuable addition to Hovione’s leading offering in solubility and permeability enhancement for NCEs and nutraceuticals and affords formulators new options which address unmet needs of the industry.”

Ole Wiborg, the CEO of Zerion, comments: “Hovione is the global leader in the field of producing amorphous solid dispersions by spray-drying and this extension of our partnership again confirms the huge potential of our Dispersome® technology. If one company in the pharma industry can truly judge its value, it is Hovione, and we have a strong belief in sharing our technology with Hovione, who will secure its use with more drugs and ingredients and in applications across several delivery routes. Thus, we expect substantial revenues from the collaboration in the years to come.”

Through their partnership, Hovione and Zerion are offering pharma, biotech and nutra companies worldwide access to an innovative delivery platform combined with an unparalleled experience in formulation development, scale-up, and GMP manufacturing.

The Dispersome® technology

Zerion has pioneered the Dispersome® technology that addresses poor drug solubility, one of the most recognized drug development challenges. The Dispersome® technology increases solubility and bioavailability of poorly soluble compounds and can be applied at any stage of drug discovery or drug development, including in preclinical studies, first in human studies, and reformulation of existing drug products.

 

About Hovione
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.

About Zerion Pharma A/S
Zerion develops its own proprietary drug formulations and offers its Dispersome® technology platform to established pharma companies as a means to solve their challenging drug solubility problems. Zerion was established in 2019 as a spinout of the University of Copenhagen.
 

 

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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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Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US

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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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