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Press Release / Mar 18, 2024

Hovione and GEA Strengthen Partnership to Advance Continuous Tableting Technology

The agreement furthers Hovione´s ability to bring the benefits of continuous tableting, including reduced time to market and increased supply chain flexibility, to pharmaceutical customers globally

GEA Press Release_Hovione
  • Hovione and GEA further strengthened their partnership, resulting in the launch of the ConsiGma® CDC flex Continuous Tableting Technology and the installation of a lab-scale R&D rig in Hovione´s facilities in Portugal.
  • The agreement furthers Hovione´s ability to bring the benefits of continuous tableting, including reduced time to market and increased supply chain flexibility, to pharmaceutical customers globally.
  • A presentation explaining how the technology has advanced will take place during a conference in Portugal (16–18 April), organized by Concept Heidelberg.

Lisbon, March 18, 2024 – Hovione, the specialist integrated CDMO and leader in spray drying and particle engineering, and GEA, a global leader in process technology for the pharmaceutical industry, today announced the next stage of their partnership, with new development agreements, the launch of the ConsiGma® CDC flex as well as the installation of a new lab-scale R&D Continuous Tableting rig in Hovione´s facilities in Portugal.

The two companies’ collective and complementary knowledge of continuous tableting is being applied to streamline the technology and make it more accessible to pharmaceutical customers worldwide. The two expert teams are collaborating to bring continuous tableting to the same level of maturity as batch tableting, thereby capturing the known benefits of continuous manufacturing while reducing the downsides.

The ConsiGma® CDC flex (patent pending), has been designed as a truly versatile system which can operate seamlessly in both continuous and batch modes and offer both high and low throughput functionality. With a focus on user-friendliness, the ConsiGma® range will be augmented further with new developments to simplify routine development operations and introduce automated workflows and Smart controls interfaces, empowering operators to streamline production processes.

GEA will also supply Hovione with lab-scale feeding and blending systems for research and development (R&D) applications which will bolster Hovione’s current GMP equipment for both continuous direct compression (CDC) and wet granulation continuous tableting and complement the non-GMP test capabilities of GEA in Wommelgem.

Since signing the original collaboration agreement last year, the two companies have worked predominantly on two areas of the partnership: technology development and the joint promotion of continuous tableting. Presentations explaining how the technology has advanced will take place during the continuous tableting conference in Cascais, Portugal (April 16-18), organized by Concept Heidelberg, and another event Princeton NJ, USA (September 16-18), organized by Continuous Manufacturing Forum.

“We believe that continuous tableting can offer significant benefits to our customers, not only by shortening time to market and reducing development and manufacturing costs but also by improving product quality and sustainability”, commented Filipe Gaspar, VP Technology Intensification at Hovione. “Through our collaboration with GEA, we aim to revolutionize the continuous production of oral solid dosage forms, making the technology more accessible and efficient for pharma customers.”

 

“Hovione and GEA benefit from a very large and complementary pool of continuous tableting experts; together, their collective knowledge is being applied to make continuous processing much less complex” stated Phillip Gabb, Strategic Business Director, Pharma Solid Dosage at GEA Pharma & Healthcare. “There is an industry perception that a lot of highly qualified and well-trained people are required to run a continuous line. The partnership’s intention is to simplify that, make it no different to running a standard tablet press and enable existing operators — with the right guidance — to use continuous manufacturing equipment.” 

Background information

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.  
 
Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

About GEA

GEA is one of the world’s largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components and comprehensive services. With more than 18,000 employees, the group generated revenues of about EUR 5.4 billion in more than 150 countries in the 2023 fiscal year. GEA plants, processes, components and services enhance the efficiency and sustainability of customer’s production. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company’s purpose: ”Engineering for a better world“.

GEA is listed on the German MDAX the European STOXX® Europe 600 Index and is among the companies comprising the DAX 50 ESG, MSCI Global Sustainability as well as Dow Jones Sustainability World and Dow Jones Sustainability Europe Indices.

 

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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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