The Finnish Medicines Agency has granted GMP certification to nanonization specialist Nanoform Finland, the company said. In December 2019, Nanoform announced that it had applied for the certification. The company’s CESS (controlled expansion of supercritical solutions) nanoparticle engineering platform will now be available for manufacturing of clinical trial supplies of investigational medications.
Nanoform CEO Edward Hæggström said, “Achieving GMP status constitutes another landmark moment in Nanoform’s history. This facility represents the first GMP nanoforming capability in the world, and we look forward to supporting an increasing number of clients with their drug development projects and providing patients with faster access to life-changing treatments.”
Head of Manufacturing David Rowe added, “I am incredibly excited that we have been awarded GMP status to supply nanoformed API for use in human trials. By securing our first GMP licence, and employing cutting-edge manufacturing methodology, we are ready to deliver ‘designed-for-purpose’ API nanoparticles to the pharma industry for developing the next generation of medicines for patients.”
Read the Nanoform press release.
