Ardena signs agreement to acquire Catalent manufacturing facility

In a significant move that marks the beginning of a new era in pharmaceutical development, Ardena, a leading Contract Development and Manufacturing Organization (CDMO), has announced the acquisition of Catalent’s state-of-the-art oral solids development and small-scale manufacturing facility in Somerset, New Jersey. This strategic acquisition is expected to significantly enhance Ardena’s capabilities in downstream late-stage and small-scale commercial manufacturing of oral drug products, further solidifying its position as a major player in the global pharmaceutical industry.

A New Milestone in Pharmaceutical Innovation

Ardena, headquartered in Ghent, Belgium, with facilities in Belgium, Spain, the Netherlands, and Sweden, has long been recognized for its expertise in advanced drug development, particularly in complex molecules. The acquisition of the Somerset facility marks a pivotal moment for Ardena as it expands its footprint into the U.S. market. This move not only underscores Ardena’s commitment to global expansion but also highlights the company’s dedication to providing cutting-edge solutions to biopharmaceutical companies.

The FDA-approved Somerset facility, which employs approximately 200 skilled scientists and technicians, is renowned for its advanced delivery of oral dosage forms. It serves as a Center of Excellence for oral solid formulations, complementing Ardena’s existing oral solid expertise. This acquisition positions Ardena well to expand its bioanalytical services in the U.S., catering to an ever-growing client base driven by the increasing demand for advanced drug development services.

Enhanced Capabilities and Technologies

The acquisition is set to bolster Ardena’s integrated offering with specialized technologies and analytical capabilities. The Somerset facility features advanced technologies such as Hot Melt Extrusion, which enhances bioavailability improvement solutions. This aligns perfectly with Ardena’s expertise in developing innovative nanomedicine drug delivery systems. The investment is expected to accelerate Ardena’s scale of operations and broaden its offerings, better serving its fast-growing international client base.

Key Services and Expertise

Ardena’s comprehensive service portfolio includes:

• Solid State Chemistry: Understanding the structural properties of solids to optimize drug formulations.
• API Development: Active Pharmaceutical Ingredient development, ensuring high-quality and compliant drug substances.
• Nanomedicine Development: Creating innovative drug delivery systems using nanotechnology.
• Analytical and Formulation Development: Advanced analytical techniques and formulation strategies for optimized drug products.
• Drug Product Manufacturing: Scalable manufacturing solutions for commercial oral drug products.
• Bioanalytical Services: Comprehensive bioanalytical support for drug development and clinical trials.
• CMC Regulatory Services: Regulatory support for managing drug development and manufacturing processes.

Ardena’s mission is to enable current and next-generation therapies to reach patients faster. By providing integrated services throughout the drug discovery and development process, Ardena assists biopharmaceutical companies in navigating complex regulatory landscapes and ensuring compliance at every stage.

Catalent’s Transition and Future Plans

While Ardena takes over the Somerset facility, Catalent will continue to operate its corporate headquarters there during a transition period. The exact location for Catalent’s new headquarters has not been announced yet, but it is clear that both companies are committed to a smooth transition process. This period will allow Catalent to relocate its operations while maintaining its presence in the pharmaceutical industry.

In recent years, Catalent has significantly expanded its capabilities in oral solid formulations. Notably, in October 2022, the company acquired a 333,000-square-foot facility in Greenville, North Carolina, for $475 million. This facility specializes in turnkey solutions for oral solid dosage forms, including formulation development, analytical services, commercial manufacturing, and packaging.

Ardena’s Expansion Strategy and Future Prospects

This acquisition is a significant milestone in Ardena’s international growth strategy. It underscores the company’s commitment to expanding its global footprint while enhancing its technological and market capabilities. By integrating the Somerset facility into its operations, Ardena aims to provide comprehensive solutions for pharmaceutical and biotechnology customers on both sides of the Atlantic.

Jeremie Trochu, CEO of Ardena, expressed excitement about this acquisition. “Today marks a significant milestone in Ardena’s international growth strategy,” he said. “We are thrilled to welcome the talented scientific and operations team from Somerset into the Ardena family. Their commitment to providing exceptional service aligns perfectly with our core values of excellence, reliability, care, and integrity. Together, we will continue to support biopharma companies at the cutting edge of innovation to deliver life-changing therapies to patients worldwide.”

Conclusion

The acquisition of Catalent’s Somerset facility by Ardena marks a new chapter in the pharmaceutical industry. It highlights the evolving landscape of contract development and manufacturing organizations as they strive to provide cutting-edge solutions to an ever-increasing demand for advanced drug development services. As Ardena continues to expand its capabilities and presence globally, it solidifies its position as a leader in pharmaceutical innovation.

References

• Catalent Signs Agreement to Sell Somerset, NJ Oral Solids Facility.
• Ardena Signs Agreement to Expand US Footprint with the Acquisition of Advanced Drug Product Manufacturing Facility from Catalent.
• Ardena Signs Agreement to Expand US Footprint with the Acquisition of Advanced Drug Product Manufacturing Facility from Catalent.