Ian Shott is chairman of BPE, one of the UK’s leaders in engineering process design. Here, he explores why continuous processing is seeing such a rise in popularity within the pharmaceutical sector.
For decades, the cost of pharmaceutical manufacturing has been low, compared to the returns made on new patented prescription drugs. However, that landscape is changing – not least due to the patent cliff of the last decade – and the cost of goods for major pharmaceuticals is increasingly under the spotlight.
In order to grow their businesses, and against a backdrop of more strongly regulated developed markets and more cost sensitive developing markets, there’s a greater need to reduce costs. And while the industry has traditionally been risk (and therefore change) averse, the time has now come for more advanced process understanding, measurement, and control. The resulting trend is a move towards continuous processing.
For an industry to evolve you must have both innovation and opportunity. Technology, place, attitude and era must all come together for change to happen and that’s exactly what we’re now seeing with continuous processing in pharmaceuticals. The entire supply chain is plugged into the pharmaceutical industry’s need for change. Now that it is recognised that a fundamental shift is needed, we see a consequential appetite to unlock the next wave of technology.
We are experiencing a new sense of openness and willingness among companies in the pharma supply chain to now create new technologies that will accelerate and intensify production and dramatically increase efficiency, hence reducing cost of goods. Among them is BPE, which is an industry leader in continuous processing and has helped a number of businesses move from batch to continuous in recent years.
Alongside this we’re seeing the advance of biotechnology, and the ability to engineer organisms to produce highly stereospecific enzymes. The use of engineered enzymes can significantly reduce the number of processing steps and hence, simplify the overall synthesis pathway.
These two advances, when combined, are extremely powerful. One can be used to reduce the number of stages during production and the other can be used to accelerate progress through those stages.
Making such a significant change in production can understandably be a daunting prospect for pharmaceutical firms. After all, this is an industry where delays or quality problems are highly expensive and new technology and process change does present risks that have to be understood, managed, mitigated, minimised or eliminated.
Having the ability to model and design a new continuous process iteratively is therefore an essential step in increasing predictability of outcome and that’s exactly where BPE is helping its customers. BPE has access to the latest innovative modelling techniques, which maximise predictability, hence minimising risk.
These modelling techniques, in combination with continuous processing, can create much more reliable and effective process scale-up.
Well-established continuous process design methodology has been vastly improved through digitalisation and machine-learning algorithms to improve accuracy and predictability. But it’s not just the pharmaceutical industry reaping the benefits. This has a far wider impact.
The industry’s willingness to embrace continuous processing has had a ripple effect and now other industries, such as fine chemicals and cosmetics are using it too.
With the benefits including greater efficiency, cleaner and greener processing, improved quality control, reduced cost and reduced risk, it’s an incredibly exciting prospect that soon even more industries could be embracing the use of continuous processing with a consequential societal benefit.