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

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.¹ 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.¹ 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.¹ "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.¹ 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.¹ "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.¹ 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.² 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.¹ 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.

References

1. Hovione. Hovione to commission world’s first ConsiGma® CDC Flex, bringing next-generation continuous tableting to the U.S. News release. Published October 5, 2026. Accessed October 5, 2026. https://www.hovione.com/
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Q13 continuous manufacturing of drug substances and drug products: guidance for industry. Published March 2023. Accessed October 5, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q13-continuous-manufacturing-drug-substances-and-drug-products-guidance-industry