Hovione, a globally integrated pharmaceutical contract development and manufacturing organization (CDMO), announced on Oct. 5, 2026, that it will commission the world's first ConsiGma® CDC Flex. a next-generation continuous tableting line. at its East Windsor, New Jersey, campus in late 2027.

Expansion of Hovione's Capabilities at the 89 Twin Rivers Facility

The line will be installed at 89 Twin Rivers, the company's recently opened facility, expanding Hovione's drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the United States.

The project represents an investment of USD 35 million. Once installed, it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through to commercial tablet production, all at a single site and under one quality system.

Executive Perspective on the Investment

"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-Chief Executive Officers of Hovione. "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."

David Basile, Vice President of Technical Operations, Americas for Hovione, said that installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated U.S. development and manufacturing workflow.

"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," he said.

Flexible Throughputs From Development to Commercial Scale

The new ConsiGma® CDC Flex will operate in continuous or batch modes across a broad throughput range of 1 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 capability is enabled by specialized design within the ConsiGma® CDC Flex to effectively switch between continuous blenders of various sizes.

The line will also be installed for containment to 1 µg/m³, supporting the handling of highly potent compounds. According to the announcement, this combination of features enables customers with complex and diverse pipelines to progress from development to commercial production without traditional scale-up.

Continuous Tableting and the Regulatory Landscape

Continuous tableting is reshaping the manufacturing of oral solid dosage medicines and is well suited to programs 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 provide real-time quality monitoring.

The regulatory environment has also evolved to support the technology. In 2022, the ICH Q13 regulatory framework guidance specifically for continuous manufacturing of drug substances and drug products was adopted, providing harmonization across the U.S., Europe, and Japan.

As of 2024, 17 products manufactured under the international guidance had been approved by the U.S. Food and Drug Administration (FDA) alone.

The GEA Collaboration Behind the Platform

The ConsiGma® CDC Flex platform was developed jointly with GEA. Hovione and GEA established a strategic collaboration in 2022 to advance continuous tableting, combining Hovione's pharmaceutical development and manufacturing experience with GEA's process-engineering expertise.

The partnership is focused on simplifying the technology, increasing its flexibility, and accelerating its adoption by the pharmaceutical industry.

In 2024, the collaboration entered a new phase with the launch of a first-generation ConsiGma® CDC Flex and the installation of a lab-scale R&D continuous tableting rig at Hovione's facilities in Portugal.

In 2025, the two companies introduced further developments to the platform, including 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, SimpleCT simplifies operation, improves efficiency and containment, and enhances operator safety.

Hovione currently operates ConsiGma® technology end-to-end for commercial continuous tableting at its Loures site in Portugal and is the only CDMO offering this capability. The planned installation at East Windsor represents the next stage of the collaboration and will extend this capability to the U.S. when commissioned in 2027.

Hovione's Position in the CDMO Market

Hovione is an international company with over 65 years of experience in pharmaceutical development and manufacturing operations.

As a Contract Development and Manufacturing Organization, the company offers a fully integrated suite of services for drug substances, particle engineering and drug products. Hovione has four FDA-inspected sites in the U.S., Portugal, Ireland, and China.

Today, Hovione partners with 19 of the world's 20 largest pharmaceutical companies and is involved in up to ten percent of medicines approved annually by the U.S. Food and Drug Administration.

Looking Ahead to 2027

With the commissioning of the ConsiGma® CDC Flex at East Windsor planned for late 2027, Hovione will become the first company in the world to offer the platform.

The installation at 89 Twin Rivers will extend the company's existing continuous tableting capability from its Loures site in Portugal to the United States, adding continuous and batch operation, throughputs from 1 to 200 kg/h, containment to 1 µg/m³, and an integrated route from spray-dried amorphous solid dispersions to commercial tablet production on a single campus.

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