Rising Demand Spurs GMP Capacity Increase And New High Potent Handling Capabilities At Nanoform's Helsinki Facility

In today’s pharmaceutical development pipeline, about 70% to 90% of the molecules under development are poorly soluble and could benefit from nanoparticle engineering. This, combined with the increasing opportunity for novel nanoparticle drug delivery approaches, has driven Nanoform to set up our own GMP facility in Helsinki, Finland to manufacture API nanoparticles created by our small-molecule nanoparticle technology, Controlled Expansion of Supercritical Solutions (CESS®).

In 2022, we are tripling our nanoforming GMP API manufacturing capacity and adding GMP analytical development and characterization capability. This expansion program will add two new CESS® manufacturing suites in class-D cleanrooms to triple our CESS® nanoforming capacity in line with increasing customer demand. It will further establish internal state-of-the-art GMP analytical capabilities to support partners relying on our GMP operations for their product development. These two additional manufacturing suites, together with the GMP analytical characterization laboratories, are geared to handle highly potent compounds (OEL <30 ng/m3), and will increase our ability to support our customers’ highly potent small-molecule particle engineering needs. This expansion, expected to be operational in Q4 2022, will enable our clients to leverage the value of our technology for their clinical and commercial programs.