Challenge
Fisons required flexible API manufacturing capacity in order to produce launch quantities of new drugs and implement novel manufacturing methods which would allow registration without delaying drug availability and regulatory re-approval for manufacturing process changes
Solution
Bob lead a project team to re-design procure, construct and modify the existing general purpose plant. Based on 3 candidate drugs the plant was commissioned, qualified and handed over for manufacturing operations. Approved changes to the candidate drugs, and changing validation standards, extended the project schedule and costs.
Result
The client was able to start Phase 3 clinical trials on schedule, and re-licence the manufacturing process for one candidate drug, because of the flexability afforded by the design. Product from this was then used for vialling and storage trials which formed part of the licence application.