Know-How Technology Transfer From R&D To Manufacturing

Each product needs to be transferred from R&D scale to commercial manufacturing scale. This requires precise project planning at an early stage, a competent project team, a sophisticated application system and a filing strategy which meets the time-to-market approach. The example in this article shows a freeze-dried dual-chamber system introduced in clinical phase III and transferred to a third-party manufacturer. The different planning steps and milestones with respect to key questions, conditions, results and further actions are discussed.

Project Planning
Precise planning is required for an upcoming transfer project to ensure the time-to-market concept for a new product. The project is split into several phases: project pre-phase, project start-up, development phase, validation and handover to commercial production. It is extremely important for both parties to establish competent project teams. The project managers coordinate the entire project and define work packages for the team members.