Challenge

Lonza’s Clients required flexible Biopharmaceutical manufacturing capacity in order to implement novel manufacturing methods which would allow registration with the new methods without delaying availability while waiting for regulatory approval for early stage manufacturing process changes

Solution

Bob lead a project team to work with the client and a contractor to Fast Track design, procurement, commissioning, and qualification of the development scale facility. The plant was delivered with 3 new innovative processes working, 2 months ahead of schedule and for less than budgeted. 

Result

The client was able to start Phase 3 clinical trials ahead of schedule, licence the manufacturing process based on robust manufacturing performance and ship the finished goods worldwide using innovative but robust shipping methods.