Drug Delivery System Manufacturing Process

Enabling the manufacturing of a novel new technology

Our customer, a specialty drug delivery company, had developed a novel technology to precisely dispense a drug product with an implantable osmotic pump. This enabled long term treatment of chronic conditions like pain management. The delivery system had been designed and tested on the bench top but a controlled manufacturing process was needed to scale up production for clinical studies.

The Challenge

Develop a reliable manufacturing method

The challenge was in developing a method to reliably manufacture this unique product within very tight tolerances and in an aseptic process. Processes had to be developed to sterilize components prior to assembly. And the filling, assembly, and in-process inspection methods had to be engineered in such a way that they could be performed consistently and without risk of contamination.

The Solution

Design custom machines to meet the needs of each unit

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

The Results

Technology is ready for clinical production

MPR’s ability to appropriately balance customized and off-the-shelf equipment in a comprehensive production process enabled creation of a completely validated manufacturing process that was ready to support clinical production. And parallel execution of process development, facility readiness, and validation activities was critical to shorten the timeline, enabling the client to be ready to make clinical batches within 8 months.

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