Minerva Imaging has shipped the first 64Cu-labeled diagnostic for a Phase II clinical trial from its CDMO facility in Denmark. 

Ølstykke, Denmark – June 26th, 2024 

Today, Minerva Imaging has shipped the first clinical dose for a phase II clinical trial. Minerva will be supplying clinical doses on a regular basis for trial sites in both the EU and the US.  

Carsten H. Nielsen, CEO and co-founder:
“The shipment of our first clinical dose marks a very important milestone for Minerva Imaging. Our state-of-the-art CDMO facility was GMP-certified by the Danish Medicines Agency on September 1st 2023 and we are excited to initiate clinical supply for this clinical trial. This is a very important step for our vision of offering best–in–industry, fully integrated radiopharmaceutical research, drug development and manufacturing services – all under one roof.”

Fully integrated CRO and CDMO 

Building on a very successful track record of more than twelve years of preclinical services and serving more than 140 global pharma and biotech companies, Minerva started operation of a state-of-the-art CDMO facility in 2023 for development and manufacture of Theranostic investigational medicinal products for clinical trials. Fully integrated with our CRO services, we now provide a complete service offering, covering all the steps from early preclinical target validation to clinical manufacturing and supply under GMP/GDP for First-in-Human studies and beyond.

Development and manufacturing activities for 2025 and beyond are currently being booked and we encourage partners to engage early in the planning of clinical manufacturing, to ensure access to the required CDMO capacity.


More information 

For more information about our CMC/CDMO services for development, manufacturing, and clinical supply of radiopharmaceuticals, please click here or contact Eske Rygaard-Hjalsted, Sr. Business Developer for the CDMO.


About Minerva Imaging

Minerva Imaging is an integrated CRO and CDMO specialized in targeted radionuclide therapies. The company focusses on the use of advanced models within oncology, cardiovascular diseases, and in vivo molecular imaging for translational research and drug development. Minerva Imaging engages with its clients to understand their scientific questions and discuss how its methods and capabilities can provide answers. The facility located in Denmark offers best–in–industry fully integrated radiopharmaceutical research, drug development and manufacturing services.
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