Nanoform Finland Plc , 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.
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.”