Challenge
Takeda Grange Castle project was a strategic investment for flexible API manufacturing capacity in order to produce launch quantities of new drugs in EMEA and rest of the world (RoW). The requirement was to complete construction, commissioning, and qualification of the facilities and the fully equipped support laboratory ready to receive 5 candidate drugs in late stage development.
Solution
Bob lead a contract, team of commissioning and validation engineers from preparation of the necessary verification and validation protocols for all control systems, equipment (including all laboratory bench and fixed equipment), through protocol execution and final reporting. By focussing on the operating windows required for each of the 5 candidate product intermediates were encompassed and achieved, a reduced level of testing was possible. The team also provided the practical hands-on turnover of the systems, pre-commissioning, commissioning and performance optimisation followed by handover for beneficial operation.
Result
The processes for verification and validation were simplified and honed to minimise deviations and incidents that could delay acceptance and qualification. The client was able to start Phase 3 clinical trials on schedule for the lead candidate drug because of the flexibility afforded by the design.
