small is GMP approved for highly potent APIs
With 14 R&D and 3 GMP CESS® lines capable of handling highly potent compounds, Nanoform can meet your material needs at up to the multi ton-per-year scale
In 2019, Nanoform invested in its first cleanroom and GMP-compliant production line, then significantly increased its GMP manufacturing capacity by adding two new facilities in 2025.
Nanoform can handle most APIs with containment to 0.03 µg/m3 and scale manufacturing up to multiple tons per year using a single GMP line, enough to satisfy demand for the overwhelming majority of innovative APIs.
Recipe control via automation is built in providing product quality benefits via controls of critical processing parameters with accurate and repeatable performance and consistent quality. GMP suites are equipped with clean-in-place (CIP) and wash-in-place (WIP) capabilities, enabling faster and more efficient changeovers between campaigns. Ongoing automation projects will streamline manufacturing work still further enabling automated batch report generation. With predefined formulation and process controls, production is automated throughout, from loading raw materials to harvesting nanoparticles.
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GMP manufacturing works in close cooperation with QA and QC functions to ensure quality and compliance in all production activities and guarantee the robustness of Nanoform’s manufacturing operations, empowering us on our path for world-class excellence in pharmaceutical production.
Our GMP activities are regularly inspected by the Finnish Medicines Agency (Fimea) a member of the European Medicines Regulatory Network. Nanoform’s GMP Certificate is available on the EudraGMDP Database.
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