The high rate of clinical attrition, combined with the increasing opportunity for novel nanoparticle-based approaches, has driven Nanoform to set up our own GMP facility in Helsinki, Finland. This enables us to manufacture API nanoparticles created by our award-winning CESS® small-molecule nanoparticle engineering technology to GMP standards. Our GMP facility is currently able to handle OEB4 (1ug/m3) compounds.
In line with customer demand, we have further embarked on an ambitious expansion project to triple our GMP nanoformed API manufacturing capacity in 2022. This expansion program will add two new CESS® manufacturing suites (to OEB5 containment) in class-D cleanrooms. The two additional manufacturing suites, together with new GMP analytical characterization laboratories, are geared to handle highly potent compounds (30ng/m3 containment in place). Expected to be operational in Q4 2022, this expansion will enable our clients to leverage the value of our technology for their clinical and commercial programs.