Ardena, a Contract Development and Manufacturing Organisation (CDMO) specialising 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 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, commented: “There is a growing demand for expert nanomedicine services. The €20m expansion of our advanced nanomedicines facility represents a significant investment for Ardena. With this expanded capacity, we are well-equipped to advance nanomedicine research and development, accelerate the development and manufacturing of 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 4,000m2 facility 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.