PHARMACEUTICALS
Rather than treating a decades-old, already-successful product as a supply-continuity exercise, the Cork team took a different approach. The drug’ s high volume and batch count made it a strong candidate for improvement, because at that scale, even small gains in yield or cycle time compound significantly across hundreds of batches.
The business case for investing in a mature process is different from the case for a new one. Freeing up manufacturing days on an established process creates capacity for new programs, supports faster customer timelines and can lower cost per batch.
Structured methodology
Improvement in a mature process starts with reviewing the data. Teams must align on manufacturing performance, downtime, bottleneck steps and mass balance before a target condition can be reestablished.
From there, a fishbone-style analysis( Figure 1) gives crossfunctional teams a structured way to identify where gains are possible. This approach maps potential causes of a performance gap across six categories( materials, measurements, machine, methods, environment and people) so a team can trace an issue back to its root cause instead of guessing at fixes or chasing the most visible symptom.
Once areas of optimisation are identified, they need to be tested and confirmed with downtime analysis and process modelling alongside laboratory studies. The team can then set an incremental target condition with a specific, measurable goal, like a defined cycle-time or throughput number, which represents the next achievable step. This keeps improvement work grounded in what is actionable before moving the target again, rather than chasing a distant ideal state and losing momentum along the way.
Continuing with the Parkinson’ s example, a four-year partnership spanning operations, engineering, quality and process development delivered a 5 % increase in process yield and more than doubled manufacturing throughput, from 1.5 to 3.5 batches / week. Those improvements translated to campaign savings of approximately € 500,000 and a 50 % reduction in standard campaign length.
A central intervention was the installation of a bespoke agitator, a significant capital undertaking that required rethinking a core piece of fixed equipment on an alreadyrunning commercial line. That enabled up to seven hydrogenations / week, up from a lower baseline rate, and delivered a steep change in cycle time. Alongside it, the team expanded and optimised the process train to remove downstream bottlenecks created by the faster upstream pace and continuously refined operator standard work so that the gains held steady batch after batch, independent of any one shift’ s execution.
Not every improvement effort succeeds on the first attempt, and the methodology expects that. I have seen instances where our lab-based assumptions did not hold up once a process moved to commercial scale, and in those cases, the right move was to reassess and adjust course instead of pushing forward with a plan the data no longer supported.
Thermo Fisher ' s site in Ringaskiddy, Ireland
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