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.
The Manufacturing Strategy is Central
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. The strategy will be refined continually as needed, but it will always be 100% aligned with your clinical builds requirements and intended production volume expectations. It will describe how we do molding, electronics, supply-chain and assembly as well as how the different elements of your production will be brought together. We have great insights into clinical phases, and we do our manufacturing strategies based on these insights. For example, regulatory requirements and the needs for documentation and validation are less massive during the first engineering build and the subsequent clinical phase 1 and clinical phase 2, which is why we often do these phases in our dedicated clinical build facilities.
Dedicated Clinical Build Facilities
Our dedicated clinical build facilities are of the highest standards. Here we do PCBA printed circuit board assembly manufacturing, embed connectivity electronics, handle drugs in Class 7 (10,000) and Class 8 (100,000) certified clean rooms as well as do combo products, and have production molding capabilities, and much more. Normally, you only see this combination of capabilities in the most modern production facilities, so having these in dedicated clinical build facilities is obviously an advantage. At these facilities, we run a phase-appropriate, flexible quality management system (QMS). By doing this, we save you time and money.
We Will Get You Ready
Going from phase to phase in the clinical manufacturing, we will get you more and more ready for commercial manufacturing. We often do clinical 1 and 2 builds in a clinical build facility, but the clinical build 3 could be done at the same location or done in the production intent facility. By this phase you will have a production process ready for scale-up commercialization, whatever the necessary scale may be in your case.
During clinical manufacturing, we will mature all steps and parts of your production manufacturing process. Internally, we sophisticate the QMS setup and the full production line, whether it be semi or fully automated. Externally, we pick the right suppliers and take full responsibility for the supply chain. The suppliers you pick for the first build become default suppliers for the subsequent builds, so it is imperative that you choose the right suppliers from the beginning. We have long-standing partnerships with many of our suppliers, and we know what to look for when we are picking new ones.
Where to Go from Here?
Once your product has gone through clinical trials and has obtained regulatory approval, you are ready to move to commercial manufacturing.