Pharmaceutical and biotechnology companies can now partner with 3M on development and conducting clinical trials using the 3M™ Hollow Microstructured Transdermal System (hMTS). Patient-friendly and easy to use, 3M hMTS is designed to open new opportunities for pharmaceutical companies and patients.
The device’s availability for clinical trials follows a number of studies and design verification tests. Based on 3M micro-replication technology, pharmaceutical and biotech companies can take advantage of this patient-friendly, hollow microneedle device for difficult-to-deliver biologics.
To reach this current stage of clinical readiness with the hMTS device, 3M has undertaken a rigorous process, including finalizing the device design, manufacturing critical components from medical-grade materials, establishing GMP array manufacturing and device assembly, as well as filing documentation with FDA.
3M 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 very good delivery times for 2 mL (less than 2 min on average). These results provide foundational data in assessing the safety of the device.Clinical supplies are now available for assessment in potential development partners’ trials.
hMTS benefits include reproducible intradermal delivery, a proven ability to deliver formulations up to 2 mL with various viscosities, and API-dependent PK profile benefits. The system’s patient-friendly features and the ability for patients to easily self-administer drugs open new opportunities to move treatments out of the clinic and into the patient’s own home.
