Pharmaceutical CDMO Hovione has said that it is set to commission the world’s first ConsiGma CDC Flex continuous tableting line at its East Windsor, New Jersey campus in late 2027, following a $35m investment in the technology.
The next-generation continuous direct compression (CDC) platform, developed in collaboration with GEA, will be installed at Hovione’s recently opened 89 Twin Rivers facility.
The investment is intended to expand the company’s US drug product capabilities while creating an integrated manufacturing pathway from amorphous solid dispersion (ASD) production via spray drying through to commercial tablet manufacture.
The new line will be able to operate in both continuous and batch modes, with throughputs ranging from 1 to 200 kg/h.
It will also let customers begin formulation development with quantities as small as 1.5 kg before progressing to clinical and commercial production on the same manufacturing platform.
From formulation development to commercial production
Hovione said the ability to switch between different continuous blender sizes was central to the CDC Flex’s flexibility, enabling the same equipment to support development, clinical batches and larger-scale commercial production.
The system will also incorporate containment to 1 µg/m³ to support the manufacture of highly potent compounds, while inline process analytical technology (PAT) and automated controls will provide real-time process and quality monitoring.
David Basile, VP of U.S. Technical Operations at Hovione, told Manufacturing Chemist: “Among the values of continuous tableting is the ability to remove some of the traditional boundaries between development and commercial manufacturing."
"A formulation can be developed with small quantities of API and then advanced to clinical and commercial production on the same manufacturing platform, preserving process knowledge and reducing the technical risk associated with scale-up."
"With the CDC Flex, we can also move between continuous and batch operation and accommodate a very broad range of production volumes."
That flexibility is particularly important for our customers with complex formulations and high-value APIs, where material efficiency and process control can have a meaningful impact on a programme.
Building an integrated New Jersey manufacturing hub
The CDC Flex installation will build on Hovione’s expansion at 89 Twin Rivers, which opened in September following a $100m investment in its US operations.
The 31,000 sq ft facility added two GMP-ready, commercial-scale PSD-3 spray dryers, doubling Hovione’s US spray drying capacity.
The site, the company said, was designed to strengthen an integrated pathway for spray-dried ASDs from development through to commercial manufacturing under one quality system, helping to reduce technology transfer and improve manufacturing continuity.
The company also has plans to expand the East Windsor campus further during the next five to ten years, including a proposed 125,000 sq ft manufacturing facility incorporating additional laboratories, commercial-scale spray drying and oral drug product manufacturing.
Hovione and GEA have been collaborating on continuous tableting since 2022.
Hovione currently operates ConsiGma technology for commercial continuous tableting at its Loures site in Portugal and describes itself as the only CDMO currently offering this capability.
The East Windsor installation will extend that capability to the US when commissioned in 2027.
