Nanoform receives GMP certification

Published: 4-May-2020
Regulatory

The Finnish Medicines Agency has awarded Nanoform a GMP certificate for it proprietary CESS nanoparticle engineering platform

Nanoform Finland, an innovative nanoparticle medicine enabling company, has been awarded a Good Manufacturing Practices (GMP) certification by the Finnish Medicines Agency, FIMEA. Achieving GMP status permits Nanoform to manufacture an investigational drug, developed using its proprietary CESS nanoparticle engineering platform, for use in clinical trials.

The GMP certification represents a very important milestone for Nanoform as it continues to increase the commercial reach of its CESS technology, which reduces the size of API particles to less than 200nm (and in some cases as small as 10nm) to improve dissolution rates and bioavailability. This unique capability addresses a major cause of attrition within the pharma industry.

Prof Edward Hæggström, Nanoform CEO, 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."

Dr David Rowe, Head of Manufacturing, said: "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."

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