Few would argue that quality, speed and consistency are essential for successful pharmaceutical manufacturing.
Further, margins can be very slim, competition is strong, and the number of genuine, new breakthrough formulations are not only increasingly rare, but harder to commercialise.
This would seem to make pharma ripe for digitalisation, yet many parts of the sector lag behind.
Barriers include potential disruption to what may be perceived as an already efficient manufacturing process, a lack of guaranteed ROI as a result of new investment, a perceived skills deficit within the workforce, and the challenge of cybersecurity.
While many of these concerns are valid, the massive gains which can be made from embracing digitalisation in pharma processes would appear to outweigh the risks, so it’s puzzling why such levels of resistance remain.
One argument is that some vendors sell a long-term vision around ‘disruptive technologies’, ‘mass customisation’ and ‘lights-out 24/7 production’.
This fails to recognise short and medium-term needs and stokes up fear of the unknown.
Siemens, as manufacturers ourselves, understands this - and we work closely with the pharma supply chain to identify where achievable, meaningful and cost-effective gains can be made with minimum intrusion.
However, once you have buy-in at that level, you can then start to explore together the transformational potential of automation, IIoT analytics and other Industry 4.0 technologies.
This includes the Holy Grail of pharma production – a shorter time-to-market.
Through Process Analytical Technology (PAT), active ingredients can be produced in highly automated compact, closed units.
This means production steps previously performed sequentially in a classic batch process are integrated, resulting in the utilisation of assets increasing by 30%- 40%.
Less manual interventions can also see production costs cut by up to 20 %, and a product that previously took two months to finish can now take two days.
Drilling down further, imagine a continuous tableting line designed to transfer powder into coated tablets in development, pilot, clinical and production volumes via a single manufacturing cell.
The system can also perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting, coating and quality control, all in one line. This delivers significant reductions in development time, and raw material use.
With regards to formulation ingredients being added in the right quantities, and being mixed and processed to obtain the right homogeneous product in bulk – this is very labour intensive.
But by combining automation with both PAT and electronic batch recording systems, you can track product quality and process performance more efficiently, streamlining batch review and enabling real-time release of products. Process and energy costs can also be decreased, while maintaining quality and increasing efficiency.
Looking at the wider pharma production process, we can also see how digitalisation can bring significant gains in other areas.
Take raw materials and excipients. These need to be weighed-in with all ingredients prepared for formulation. Depending on the operator exposure level of the active ingredient, the whole exercise is characterised by manual operations guided by an interactive workflow.
With digital interventions, recipe execution and recording can be transformed, reducing errors, and driving more operational efficiencies.
In addition, both primary and secondary packaging can be optimised, avoiding off-spec products occurring inside the container while the external pack, inserts and labels are all consistently correct.
Then we have the optimisation of the plant itself. Having a stable, controlled environment is critical, and you need a guaranteed, uninterrupted supply of utilities like dataflow, water and, of course, power.
This is where benefits such as predictive maintenance begin to be realised, with the reduction in downtime of particular significance.
So, when looking at why pharma’s adoption of digital technologies is not accelerating as fast as expected, it’s worth remembering that batch-size one isn’t necessarily everyone’s primary goal.
But what pharma companies should be doing is starting the digitalisation process now, however modestly.
Otherwise they will quickly fall behind those already on their way.