The certification will enable a seamless transition from non-GMP feasibility studies into GMP clinical manufacture
(From left to right) Niklas Sandler, Liina Tuominen and David Rowe with the application
Nanoparticle medicine enabling company, 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.
Nanoform has implemented a new Quality Management System in preparation for the submission, having appointed talented individuals with significant experience in Quality management and GMP manufacturing.
The certification will enable a seamless 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 commercialisation 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. Building on the significant dose reduction capabilities recently evidenced by Nanoform in pK studies, the company is now well positioned to translate this value for patients globally.
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.
David Rowe, Nanoform’s Head of Manufacturing, said: “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.”
Niklas Sandler, Nanoform’s Chief Technology Officer and Accountable Director, said: “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.”