At Phillips-Medisize, we assign the same team to follow your product from manufacturing development all the way through to clinical manufacturing, which keeps all project knowledge where it belongs. The team continues to follow the manufacturing strategy outlined in the manufacturing development stage. As we go through the different clinical phases, we get you ready for commercial manufacturing.
This first version of the manufacturing strategy, outlined during manufacturing development, covers how we will go from engineering builds through clinical phases and finally scale to commercial manufacturing.
Our dedicated clinical build facilities are of the highest standards. Here we manufacture printed circuit board assemblies (PCBAs), manufacturing, embed connectivity electronics, handle drugs in Class 7 (10,000) and Class 8 (100,000) certified cleanrooms. We also build combination products and have production molding capabilities and much more. Typically, you only see this combination of capabilities in the most modern production facilities, so having these in dedicated clinical build facilities is a significant advantage. We run a phase-appropriate, flexible quality management system (QMS) at these facilities — saving you time and money.
Moving through phases of clinical manufacturing, we will get you ready for commercial manufacturing. We often do clinical phase 1 and clinical phase 2 in a clinical build facility. Still, clinical phase 3 build could be done at the exact location or done in the production-intent facility. By this time, we will have a product process ready to scale for commercialization.
During clinical manufacturing, we will mature all steps and parts of your production manufacturing process. Internally, we sophisticate the quality management system setup and the complete production line, whether semi or fully automated. Externally, we pick the right suppliers and take full responsibility for the supply chain. We have long-standing relationships with many of our suppliers, and we know what to look for when choosing new suppliers.