Drug Delivery System Manufacturing Process

Drug Delivery

The Need:   Our customer, a specialty drug delivery company, had developed a novel technology to precisely dispense the product with an implantable osmotic pump. This enabled long term treatment of chronic conditions like pain management. The challenge was in developing a method to reliably manufacture this unique product within very tight tolerances and in an aseptic process. And to have the process ready to make clinical batches within 8 months. 

MPRs Solution:   The MPR development team rapidly evaluated off-the-shelf equipment and developed custom machines to meet the needs of each unit operation  formulation, filling, assembly, and computer vision inspection. Filling required design of a purpose-built system to meet microliter accuracy requirements. To speed the project, validation methods were developed concurrently with engineering studies. At the same time, MPRs facility support team worked out the integration of the process into the Class 100 clean-room environment and ensured all utilities were available and validated.

Impact:   MPRs ability to appropriately balance customized and off-the-shelf equipment in a comprehensive production method enabled creation of a completely validated manufacturing process that was ready to support clinical trials.