Nanoform has filed for GMP status with the Finnish Medicines Agency, FIMEA.
The drug substance application for GMP clinical manufacture certification exemplifies its progress and growth in the last 12 months, states the company.
The certification will enable a transition from non-GMP feasibility studies into GMP clinical manufacture, enabling clients to deliver Nanoformed APIs to human patients in clinical trials. Achieving GMP status will further expedite international commercialization of Nanoform’s nanonization technology, which has the ability to double the number of drug compounds that reach clinical trials through improved dissolution rates and bioavailability enhancement, states the company.
A successful 2019
As winners of the Excellence in Pharma Award for Formulation at the 2019 CPhI Awards, the application rounds off a successful year for Nanoform. The company aims to continue its rapid rate of progress in 2020 once the GMP license is awarded for clinical and commercial manufacture.
“Filing for GMP status with FIMEA is a key milestone in Nanoform’s history. We look forward to working with our partners to deliver enhanced APIs to clinical trials and to help provide patients with faster access to innovative new treatments,” says David Rowe, Nanoform’s Head of Manufacturing.
“We are delighted to end this exceptional year with our application for GMP clinical manufacture certification. By expanding our manufacturing capability, we are on course to increase the number of partners who benefit from our best-in-class nanoparticle engineering technology,” says Niklas Sandler, Nanoform’s Chief Technology Officer and Accountable Director.
Photo of Niklas Sandler, Liina Tuominen and David Rowe from Nanoform with the application