New diseases call for new medications, and growing competition calls for faster, leaner processes in all areas of business. Rebecca Vangenechten, 38, describes the potential offered by automation and digitalisation for the pharmaceutical industry. She heads the pharmaceutical segment at Siemens and knows what makes the industry tick.
Rebecca Vangenechten, the recent years dominated by the pandemic have given the pharmaceutical industry even greater prominence: We’ve all experienced how long it can seem to take until a vaccine or medication reaches the market. What role does the time factor play in this sector?
A massive one! The reality is that the faster drugs or vaccines can be made market-ready, or manufactured in large volumes, the faster people can be protected from diseases, and the faster people who are already ill can be helped. That’s a huge incentive. And at the same time, it’s also true that early market-readiness keeps the costs as low as possible. And what’s more, speed also means being faster than your competitors. The time factor is therefore of major importance.
There’s a range of challenges for the pharmaceutical industry. What affects patients drives market growth for the pharmaceutical industry, especially in regions and countries that aren’t financially strong. And that impacts on the products, because they have to be affordable. Another major question is how patient data will be used in the future. What influence will it have on treatment: will patients only be willing to pay for successful treatments?
The product range is also in transition. There are many innovations in the areas of pharmaceuticals and treatments. Innovations like customised medicine – in other words, the production of individual batches for a single person – create major challenges for production. Today’s factories aren’t designed for that, and a different infrastructure and supply chain will be needed. This also comes with uncertainty: How quickly can new technologies be incorporated in existing processes? What does that mean for workflow validation? And, of course, cost pressure plays a huge role. In this regard, companies have to consider where their core business lies and think about outsourcing, as appropriate.
At Siemens, we’ve derived five main industry drivers from these challenges: flexibility, speed, quality, sustainability, and efficiency. Entities that are well positioned in these areas will be equal to these challenges and will achieve a very strong market position. The direction is clear: We need more digitalisation! It’s the most valuable all-purpose tool.
In our personal lives, we’re now accustomed to the fact that digital services make our day-to-day lives easier. A navigation app on your smartphone, for example, that takes us safely to our destination and helps us avoid current traffic congestion. Or messenger apps that enable us to stay in constant contact with our friends and family. And there are many other examples. Day-to-day business in the pharmaceutical industry is still much less digitalised, whereas other industries have certainly made more progress in this area. But there’s huge potential for digitalisation!
At Siemens, we firmly believe that when the real and digital worlds work together, the result is faster and safer production. That’s why we’ve developed an end-to-end portfolio of software and automation solutions called the Digital Enterprise to help us digitalise the entire value chain. The important thing is to understand and use the vast amount of data supplied by the industrial Internet of Things (IIoT). And that’s exactly what the Digital Enterprise does! It combines the real and digital worlds so we can utilise our limited resources to make efficient use of the limitless volume of data and make our industry more sustainable. Specifically, we’ve developed eight portfolio modules that cover the entire value chain.
Depending on what’s important to our customers, they can be used to create digital twins of prod-ucts, product lines, processes, or buildings. A digital twin links the real and digital worlds – and by recording real-time data, the virtual counter-part can document the current condition and simulate the future condition, which lays the groundwork for optimisation. It enables early recognition of problems, it can be used as the basis for in-silico tests, it and offers the opportunity to improve checking processes. With our customer GlaxoSmithKline (GSK), for example, we’ve developed a digital process twin for vaccine manufacture (p. 9). The digital twin not only makes it possible to check complex processes, it also predicts how changes would impact on those processes. This means that process engineers can perform simulations in just a few hours instead of having to construct trial facilities. This ultimately made the production process at GSK much more robust while improving the company’s product quality and increasing its speed.
When facilities are designed or built, we provide support with Integrated Engineering. It’s important in these cases to maintain an overview of the entire process lifecycle: Where is there potential for improvement? Where can we make improvements in speed? Where can processes be simplified? Siemens aims to create complete solutions that are in the customer’s best interests. For Bayer AG in Bitterfeld, for example, we integrated a new type/ instance concept incorporating both MES and DCS functions
We can also assist many pharmaceutical manufacturers with the transition to continuous production. This production method is used to manufacture active ingredients in compact, closed units with a high level of automation and less manual intervention.
The production stages that make up the sequential workflow in a traditional batch process are integrated into a comprehensive process, with quality measured in real time. Pfizer applies this method to its production in Freiburg, for example, and has just expanded its plant to include a highcontainment facility – a facility where it can produce up to seven billion tablets every year. Along with several partner companies, Siemens played a role in making this production plant one of the most modern and sustainable facilities in the world
I’d like to make one point clear to begin with, to deal with a false impression that still persists in some cases: The added value of paperless production is much more than what a purely digital version of paper documents would offer. The major advantage is that workflows become trans-parent! In paperless production, the process data, conditions, and results are recorded in detail, saved, and displayed. The processes are made more error-resistant – in other words, more robust and less susceptible to deviations – and the cost and effort of data input and documentation are reduced. Siemens can realise this using its MES solution Opcenter Execution Pharma, which fully complies with GMP (Good Manufacturing Practice) requirements and is pre-validated for its observance of all current standards for pharmaceutical production. When BioNTech converted a new plant in Marburg to produce its very popular vaccine during the COVID-19 pandemic, it was essential to begin production as quickly as possible. Part of the solution therefore involved paperless manufacturing.
We know from studies that more than half of the digitalisation projects that are initiated fail, that brownfield facilities are rarely touched, and that expertise in digitalisation is often lacking. That’s something we want to change! Siemens wants to speed up the digital transformation. That’s possible with Siemens Xcelerator, a new, open, digital business platform that provides a curated portfolio of IoT-capable hardware and software, a marketplace for them, and a powerful ecosystem of partners. Siemens makes three promises with Siemens Xcelerator: First, to turn super- complicated into super-simple. Second, to make Siemens Xcelerator products flexible by making them fully modular and interoperable in stages so that customers can select exactly what they want. And third, to focus on openness and ensure that Siemens software works well with other systems. In all these ways, Siemens will continue to be a powerful partner in the advancement of digitalisation.
Rebecca Vangenechten is heading the pharma business at Siemens since April 2020. She began her career at Siemens in July 2009 as a Business Development Consultant at Siemens in Belgium, working with end customers in the pharmaceuticals industry. She then spent five years working as Global Account Manager for a large company in the chemicals and pharmaceuticals industry at the Siemens locations in Frankfurt and Karlsruhe. Before taking on her current position as head of the Pharma Vertical, Vangenechten was responsible for Process Automation in the Middle East Region.
