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.
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.
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.