Nanoparticle technology specialist Nanoform Finland has announced the completion of a successful GMP inspection of its API manufacturing facility by the Finnish Medicines Agency (FIMEA). The company said that the agency issued no critical or major observations following the March 28, 2023 inspection, and the company’s license was renewed. An independent GMP auditor also conducted an audit in preparation for clinical manufacturing of “a currently marketed blockbuster drug,” the company added, and that inspection also produced no critical or major observations.
Nanoform completed the 600m2 GMP manufacturing facility in Helsinki in 2019. The company originally applied to FIMEA for GMP certification that same year and announced in May 2020 that the agency had granted certification.
In November of 2020, Nanoform introduced nanonization technology for biologics and the next year said that it was working with Herantis on possible nanonized nasal formulations of cerebral dopamine neurotrophic factor (CDNF). In September 2021, the company announced that it had successfully created a stable intranasal formulation of CDNF for Herantis.
Read the Nanoform press release.
