GMP Manufacturing

Source: Nanoform

Nanoform’s GMP facility utilizes its award-winning Controlled Expansion of Supercritical Solutions (CESS®) technology for the manufacture of API nanoparticles to GMP standards.

Our capabilities include the ability to handle compounds with an OEL of 1 ug/m3 and above.

Furthermore, we are expanding our API manufacturing capacity in 2023 to include:

  • Two new CESS® manufacturing suites in class-D cleanrooms that can handle highly potent compounds with an OEL of less than 30 ng/m3.
  • Recipe control via automation, providing accurate and repeatable performance.
  • Both CIP (Clean-in-Place) and WIP (Wash-in-Place) capabilities, enabling more efficient cleaning between campaigns, thereby reducing downtime and increasing API productivity.

One of our three state-of-the-art GMP nanoforming suites in Helsinki, Finland

Our GMP activities are regularly inspected by the national competent authority – the Finnish Medicines Agency (Fimea). Nanoform’s GMP Certificate is available on the EudraGMDP Database.

Contact us to discuss how our GMP manufacturing capabilities can support you.