Hovione to Install Next-Gen Continuous Tableting System in the US
Investment to strengthen an integrated US pathway from amorphous solid dispersion via spray drying to tablet production at a single site, under one quality system.
Hovione, a globally integrated pharmaceutical contract development and manufacturing organization (CDMO), today announced 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. 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 U.S.
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.
"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 US and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines.”
The new ConsiGma CDC Flex will operate in continuous or batch modes across a very broad throughput range (from 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 is enabled by specialized design within the ConsiGma CDC 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.
“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, Americas for Hovione. "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."
Continuous tableting is reshaping 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 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 harmonization across the U.S., 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.
Today, Hovione partners with 19 of the world's 20 largest pharmaceutical companies, and it is involved in up to ten percent of medicines approved annually by the US Food and Drug Administration.
