#USA #East Windsor #Hovione #ConsiGma #Continuous Tableting

Hovione to Commission World's First ConsiGma® CDC Flex

Hovione, a leading global pharmaceutical contract development and manufacturing organization (CDMO), has announced an ambitious investment aimed at revolutionizing the tableting process in the United States. The company plans to commission the world's first ConsiGma® CDC Flex, a next-generation continuous direct compression (CDC) platform, at its newly established facility in East Windsor, New Jersey.

A Significant Investment for Future Innovations

With an investment totaling $35 million, the new facility will undergo enhancements to create an integrated pathway for drug production. This pathway links the amorphous solid dispersion via spray drying directly to tablet formulation, thereby streamlining the entire production process under a single quality system.

This newly implemented system will offer manufacturers both batch and continuous operations, providing flexibility with throughput capabilities ranging from 1 to 200 kg/h. Such adaptability allows customers navigating complex pharmaceutical pipelines to transition from early development stages to full-scale production without the typical complications associated with scale-up.

Enhancing U.S. Pharmaceutical Development

The ConsiGma® CDC Flex aims to bring unprecedented flexibility, simplicity, and cost-efficiency to continuous tableting technologies. Marco Gil and António Almeida, co-CEOs of Hovione, highlighted the importance of this technology in improving access for U.S. customers. It enables a more direct and accelerated path to developing and commercializing complex oral medicines.

This innovative system will permit clients to create formulations from as little as 1.5 kg, enabling them to produce clinical batches or transition directly into large commercial runs using the same equipment. The CDC Flex is ingeniously designed to allow easy switching between various sizes of continuous blenders, optimizing the production process further. Furthermore, it will support highly potent compounds with containment levels of 1 µg/m³, ensuring safety during production.

Streamlined Workflow for Enhanced Efficiency

According to David Basile, Hovione’s Vice President of Technical Operations in the Americas, this initiative embeds continuous tableting within a cohesive U.S. development and manufacturing workflow. Such integration allows clients to transition smoothly from formulation and particle engineering to commercial tablets, all managed by a single team under one quality assurance framework.

This shift eliminates the traditional bottlenecks associated with scaling up while enhancing flexibility, process control, and supply stability.

Particularly beneficial for the pharmaceutical industry, continuous tableting addresses urgent priorities such as speed, robustness in supply chains, and optimized use of high-value active pharmaceutical ingredients (APIs). The real-time quality monitoring facilitated by inline process analytical technology (PAT) and automated controls positions manufacturers to respond swiftly and effectively to quality assessments.

The recent adoption of the ICH Q13 regulatory framework further paves the way for continuous manufacturing processes, providing essential guidance that harmonizes regulations across major markets including the U.S., Europe, and Japan. This year alone, 17 products manufactured in accordance with these guidelines received the green light from the U.S. Food and Drug Administration (FDA).

Collaboration with GEA and Future Directions

The development of the ConsiGma® CDC Flex is a product of Hovione’s strategic collaboration with GEA. Since their partnership began in 2022, both companies have been dedicated to advancing continuous tableting technologies to simplify operations and enhance flexibility. This collaboration is also responsible for a suite of automation and control tools known as SimpleCT, which offers smart interfaces that unify processes from development to commercial supply.

Today, Hovione actively partners with 19 of the 20 largest pharmaceutical companies, playing a pivotal role in approximately 10% of medicines approved annually by the FDA. The upcoming Commissioning of the ConsiGma® CDC Flex at East Windsor is set to extend its capabilities within the U.S., reaffirming its commitment to innovation in pharmaceutical manufacturing.

Conclusion

Hovione's push to integrate the ConsiGma® CDC Flex into its New Jersey facility signifies a major leap forward in the evolution of drug manufacturing technologies. Through this strategic investment, the company is positioned to remain a leader in the pharmaceutical development landscape, focusing on patient-centric innovations and sustainable growth. For continuous updates about this development and more information on their innovative services, visit Hovione's website.