Nanoform Finland Plc (“Nanoform”), 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, commented: “Achieving GMP status constitutes another landmark moment in Nanoform’s history. This facility represents the first GMP nanoformingTM 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 nanoformedTM 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.”
Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to reduce clinical attrition and enhance their molecules formulation performance through its best-in-class nanonization™ services.
For more information please visit https://www.nanoform.com/