How digitalisation is taking the pressure off pharma
The pharmaceuticals sector is facing a raft of difficult challenges today. In broad terms, pharmaceuticals manufacturing is a complex process. Patented products are licensed for a finite amount of time before they become generic, equating to a constant sense of ‘the race is on’ to be able to meet demand. Manufacturers are focused on reducing supply chain disruption, increasing batch production capacity, and reducing batch losses.
Security of supply is an ongoing challenge across the industry. Many factors impact a pharmaceutical company’s ability to ensure supply of end products. One factor could certainly be equipment failures; but others include: changing operating conditions and the impact on process health, and overall insights in the operations across their enterprise. All can cause batch quality failures, resulting in costly production losses and disruptions to supply.
That issue has been highlighted further by the advent of the Covid pandemic, during which, the industry has had to be ready at all times to quickly meet demand spikes. Some drugs have seen spikes as a result of induced or panic buying, others have seen troughs, along with shortages due to supply chain disruption. Manufacturers have had to be agile in understanding these trends and reacting to them.
The rapidity of the vaccine development has presented further challenges. It has been a huge success story, of course, with extensive and far-reaching benefits to public health but at the same time it has permanently reset expectations of what is achievable and enhanced pressure on speed to market across the industry.
The pharmaceuticals sector is also confronting an array of other long-term issues which it needs to rise to and overcome. How, for example, does it balance increasing demands to make medicines more accessible and more affordable with the need to develop pipelines of increasingly complicated therapeutics that are often more precisely targeted than their small molecule predecessors? We are already seeing the emergence of cellular and DNA-based therapies, which have the potential to be extremely effective but which could also create further challenges around cost, distribution, and production.
Going digital to drive efficiencies
The acceleration of digitalisation will be key to the industry solving these problems, enabling them to drive operational efficiencies; reduce time to insight; take faster decisions about equipment maintenance; and be more agile in supply chain management.
The overarching theme is the migration of the sector to Pharma 4.0 principles, which has been gathering pace since the pandemic began. Much of the investment towards Pharma 4.0 so far has been addressing digitalisation across the product lifecycle with a focus on opportunistically removing/replacing paper processes and piloting/developing competencies to take on larger-scale Pharma 4.0.
In more granular terms, we are already witnessing multiple examples of the benefits that digitalisation is bringing to pharmaceutical manufacturers today across all aspects of their operations.
One of the key areas of technological advancement over recent years is the evolution of predictive and prescriptive maintenance capabilities. The latest asset performance management solutions leverage such capabilities to enable pharmaceuticals companies to protect their supply chain, increase asset utilisation and avoid unplanned downtime by predicting when equipment anomalies will occur, understanding why they do and prescribing how to avoid potential failures.
Running in parallel, we are seeing solutions driving further efficiencies for pharmaceuticals manufacturers. In production lines, we have witnessed the application of digitally-aided design to drive optimisation of production and digital connectivity to help eliminate paper-based processes and human error. Tools are also coming on stream that facilitate everything from increasing collaboration from lab to pilot plant to API manufacturing right through to simulating end-to-end batch processes with first-principle models and accelerating regulatory approval and scale-up to full production. We have also seen greater utilisation of digital twins to ensure product quality, provide real-time insights, and yield immutable data integrity.
Scaling the barriers
There is huge potential for pharmaceuticals here. These digital technologies are increasingly available today and offer significant benefits for manufacturers across the space. There are, unfortunately still operational and organisational barriers in place which need to be overcome before organisations can fully embrace the advantages of the new systems and solutions.
Many large pharmaceutical companies still work in silos. Maintenance and technical teams often operate in isolation. Coupled with that, pharmaceuticals manufacturers have historically sometimes found it difficult to embrace change. All pharmaceutical businesses by necessity have well-established, often complex, proven validation processes in place. If a technology has been through this cycle and is working, in the manufacturing environment, businesses can sometimes be slow to take on further ‘evaluation pain’ in a bid to achieve a more rapid time to value.
Yet despite that, there are significant grounds for optimism. The pressures of the Covid pandemic coupled with evolving guidance from regulatory agencies around compliance is likely to be a pivotal point for the industry. With existing manual processes less easy to execute thanks to social distancing, the industry is beginning to shift its focus away from a conservatively academic outlook and on to applied innovation. We are seeing signs of a sustained shift in mindset as more manufacturers adopt Pharma 4.0 principles and start taking advantages of the multiple benefits that digitalisation can bring.