How operational excellence continues to unlock major gains in mature manufacturing processes
Stablished pharmaceutical processes can still be improved, says Alessandro Turtu of Thermo Fisher Scientific
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common assumption in commercial pharmaceutical manufacturing is that once a process reaches stability, meaningful improvement becomes hard to find. In practice, a stable process and an optimised one are different, and mistaking one for the other leaves value on the table in even some of the most established operations in a portfolio.
90 % of prescriptions dispensed in the US are for generic drugs, meaning the majority of pharmaceutical manufacturing runs through longestablished, off-patent processes rather than newly developed ones. Yet these products often carry the label of‘ mature’ and get deprioritised when it comes to allocating engineering time and capital, which instead flow toward newer, less understood processes that need optimisation upfront.
That instinct is not unreasonable at first glance as new processes attract resources precisely because they are unpredictable. They require methods, specs and manufacturing documents to be built from scratch, and teams have to brace for surprises along the way. Established processes get the opposite treatment because they are predictable. That predictability hardens into an assumption, and the assumption is what prohibits additional value from being added.
Closing that gap takes two things working together: a structured, datadriven improvement methodology applied by a cross-functional team and a manufacturing partner with
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the breadth of experience to know where to apply it. Teams that keep testing assumptions against real manufacturing data, rather than treating a long track record as a ceiling, can find meaningful room to improve even in operations everyone assumed were already running at their best.
This is also where a manufacturing partner can bring more than capacity alone. An integrated CDMO and CRO builds a kind of pattern recognition across sponsors and product types that ' s harder to develop from inside a single development pipeline. That combination, a proven methodology paired with the breadth of experience to apply it, is what turns a mature process into an ongoing source of growth.
Mindset: The dividing line
A reactive mindset treats a stable process as a finished one where critical process
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Figure 1- Fishbone-style analysis
parameters are met, batch quality requirements are consistently hit and performance is predictable. That predictability is comfortable and it is also where discussions around improvement tend to stop.
On the other hand, a proactive, continuous-improvement mindset treats every manufacturing campaign as an opportunity, regardless of how long the product has been on the market or how long the process has been established. Ultimately, the mindset distinction is about whether the team applies a structured, consistent methodology to look for gains that a‘ stable’ label might have been masking.
For example, Thermo Fisher Scientific’ s API development and manufacturing site in Cork, Ireland, was brought on board by a major global pharmaceutical company to expand supply and support increased demand for its well-established Parkinson’ s disease treatment.
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