Nanoform Finland has landed a Good Manufacturing Practices (GMP) certification from the Finnish Medicines Agency (FIMEA). With this certification, the company now can manufacture an investigational drug using its Controlled Expansion of Supercritical Solutions (CESS) nanoparticle engineering platform for use in clinical trials.
According to the company, the GMP designation represents an important milestone for its CESS nanoparticle technology, which reportedly reduces the size of active pharmaceutical ingredient (EPI) particles to less than 200 nm, and in some instances as small as 10 nm. This can help improve dissolution rates and bioavailability of drugs.
Edward Hæggström, Nanoform CEO, said achieving GMP status is important for the company
“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,” he said.
Nanoform’s head of manufacturing David Rowe said the certification signifies the firm is ready to deliver ingredients necessary to develop advanced treatments.
“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,” Rowe said.
In March, Nanoform announced a partnership with Orion, a Finnish pharmaceutical company, to use the CESS nanoparticle technology in its operation.