Hovione to Launch World's First Continuous Tableting Line in New Jersey

Hovione to Launch World's First ConsiGma® CDC Flex Tableting Line

In an exciting development for the pharmaceutical manufacturing sector, Hovione has announced the commissioning of the world's first ConsiGma® Continuous Direct Compression (CDC) Flex system at its facility in East Windsor, New Jersey. This significant advancement in continuous tableting technology is expected to be operational by late 2027, marking a major leap in drug product manufacturing capabilities in the U.S.

A Game-Changer for Drug Production

Developed in partnership with GEA, the ConsiGma® CDC Flex represents a $35 million investment aimed at integrating the manufacturing process from amorphous solid dispersion to commercial tablet production at a single facility. This unified approach is designed to enhance efficiency, reduce costs, and simplify the production process for pharmaceutical companies—particularly those dealing with complex medications.

"Hovione will be the first company globally to offer the ConsiGma® CDC Flex technology. This brings a level of flexibility and simplicity to continuous tableting that has never been seen before," stated Marco Gil and António Almeida, the co-CEOs of Hovione. This new line promises to expedite the development and commercialization of oral medicines by providing a streamlined process for pharmaceutical companies.

Flexibility Across Operations

The ConsiGma® CDC Flex will function in both continuous and batch modes, allowing for variable production rates from 1 to 200 kg/h. This versatility means that companies can use small amounts of material for initial formulation development—potentially as little as 1.5 kg—and then scale up from small clinical trials to large-scale commercial production without the need for changing equipment. This capability is particularly valuable for organizations managing diverse product pipelines.

Additionally, the system is designed to handle potent compounds safely, maintaining a containment level of 1 µg/m³ to ensure operator safety and product integrity. The new line will allow Hovione's clients to control the entire process—from formulation and particle engineering to tablet production—under one roof and quality system. This is a revolutionary step towards eliminating traditional scale-up processes, which often include delays and increased costs.

Enhancing Efficiency and Quality

Continuous tableting is reshaping the production of solid oral dosage forms. The integration of inline process analytical technology (PAT) and automation features will facilitate real-time monitoring of quality throughout the manufacturing process. Furthermore, the recent adoption of the ICH Q13 regulatory framework, which standardizes continuous manufacturing processes across various regions including the U.S., Europe, and Japan, provides an additional layer of confidence for pharmaceutical companies considering this advanced production method.

As of 2024, the FDA has already approved 17 products manufactured under these continuous manufacturing guidelines, showcasing a growing trend towards this innovative approach.

Strategic Collaboration

Hovione's collaboration with GEA is pivotal in pushing the boundaries of continuous manufacturing. Initiated in 2022, this partnership combines Hovione's extensive experience in pharmaceutical development with GEA's engineering expertise. This synergy has led to the successful launch of the first-generation ConsiGma® CDC Flex platform and the introduction of Smart automation tools, enhancing product efficiency and safety.

With an established footprint in the industry, Hovione collaborates with 19 of the world's 20 largest pharmaceutical companies and significantly influences the market with its involvement in up to 10% of FDA-approved medications annually.

As Hovione prepares to bring the ConsiGma® CDC Flex to its East Windsor facility, it signals a transformative era in pharmaceutical manufacturing—one where efficiency, flexibility, and safety converge to enhance the development of essential medicines for patients worldwide.

For more information about Hovione and its cutting-edge technologies, visit www.Hovione.com.