3M Drug Delivery Systems reports that its hollow microstructured transdermal system (hMTS), a microneedle drug-delivery system, is available for use in drug development and clinical trials. The device's availability for clinical trials comes after conducting a number of studies and design-verification tests. The system can be used for difficult-to-deliver biologics.

The process for reaching clinical readiness  involved finalizing the device design, manufacturing critical components from medical-grade materials, establishing GMP array manufacturing and device assembly, as well as filing documentation with the US Food and Drug Administration. The company also conducted a human tolerability study with the goal of selecting the appropriate microneedle array for use in clinical studies. The outcome of this study found delivery times for 2 mL (less than 2 minutes on average). Clinical supplies are now available for assessment in potential development partners’ trials.

Source: 3M Drug Delivery Systems