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.
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.