Ardena's Nanomedicines Facility Marks €20 Million Expansion with first GMP approval

Oss, The Netherlands: Ardena, a leading Contract Development and Manufacturing Organization (CDMO) specializing in bringing molecules to clinic, has received Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority for its new analytical laboratories in its expanded nanomedicines facility. 

The facility includes state-of-the-art GMP-compliant cleanrooms to support Ardena's growing nanomedicines business, as well as laboratories for process development and analytical work, GMP production space, and warehouse facilities. 

Harry Christiaens, CEO of Ardena, is thrilled with progress and this latest success for the business.  He said: "There is a growing demand for expert nanomedicine services. The €20 million expansion of our advanced nanomedicines facility represents a significant investment for Ardena and underscores our commitment to innovation and excellence in pharmaceutical development. 

“With this expanded capacity, we are well-equipped to advance nanomedicine research and development, accelerate the development and manufacturing of groundbreaking nanomedicine drugs, bring novel therapies from concept to clinic in a timely and efficient manner, and, ultimately, benefit patients worldwide."

The new 2,200m2 space, strategically located next to Ardena's existing 4,000 m2 facilities at Pivot Park, Oss, will increase the company's total footprint at the site by more than 50%. 

Following a successful inspection by the Dutch Healthcare Authority, the facility has achieved operational status for process development and GMP analytical work. In addition, the GMP license for the new production facility is scheduled to be obtained in the coming months, enabling full operational capabilities. 

Christiaens added: “These developments align seamlessly with Ardena's mission of expertly guiding clients through every stage of drug development with expertise and precision”.

For more information about Ardena and its nanomedicines capabilities, please visit  www.nanomedicines.ardena.com 

ENDS

About Ardena:

Ardena is a fully integrated Contract Development and Manufacturing Organization (CDMO) with a core focus on bringing molecules to the clinic. Our services include small and large API molecule projects, phase-appropriate drug product development and manufacturing, packaging and logistics for clinical trials, regulatory support, and leading nanomedicine development and manufacturing services. We are dedicated to seamlessly integrating our services to reduce development risks, ensure smooth project execution, and ultimately reduce time-to-clinic.