When dealing with the production of high-potent pharmaceutical ingredients, safety and regulatory compliance are key factors. With budget, time and quality considerations in mind, Synthon needed to build a facility to produce high-potent APIs in a safe and contained manner that complied with both European and US-FDA GMP requirements.

Applying high-potent production technology
After a conceptual and feasibility study, Synthon chose NNE Pharmaplan to design and construct its new facility. The company based its decision not only on NNE Pharmaplan’s expertise in GMP compliance and high-potent technology, but also on the financially enticing combination of a project team consisting of German and Czech engineers.

The facility design needed to be integrated into the existing raw building structure. NNE Pharmaplan designed the facility to minimise the space used for the critical high-potent areas – with critical process steps performed in closed systems or within safety booths.

Teamwork enables fast-track approach
With the project underway, the NNE Pharmaplan team is coordinating three partner companies for this fast-track project, as well as managing the work of several disciplines simultaneously. For example, the project is currently in the construction phase while parts of the detail design are still under preparation.

An exciting aspect of the project that has helped make this approach successful is the cooperation between Synthon’s Dutch and Czech team and NNE Pharmaplan’s German and Czech team – resulting in a harmonious and efficient working process with a multinational perspective.