Dwindling margins as a result of generic pharmaceuticals and the potential presented by a promising new cell and gene therapy from the USA: In an interview with Bilfinger now!, Christoph Herwig, Professor of Biochemical Engineering at the Vienna University of Technology, talks about trends in the pharmaceutical and life science industries and what digital twins have to do with them.
As I see it, there are two major trends. The first is cost pressure – something that the biopharmaceutical industry hadn’t previously encountered to any significant extent. This cost pressure comes from generics, which are basically copies of pharmaceuticals with the same active ingredient that are already on the market and whose patent protection has expired. Generics do not require major investments in research and development because the efficacy has already been proven by the original medication and the risk of failure in a clinical trial is much lower. This makes generics an affordable alternative. With “normal” tablets such as ibuprofen, for example, it is therefore extremely difficult for manufacturers to make any
The second trend is cell and gene therapy – a new procedure developed in the USA that is now being transferred to Europe. It involves taking blood from a patient, purifying the cells, modifying them and putting them back into the body to cure cancer, for example. Gene therapies seek to cure diseases by replacing the missing or defective version of a gene in a patient‘s cells with an intact gene. These therapies are very complex and are currently among the most expensive drugs in the world.
This is because only very small amounts of blood can be taken at any one time, limiting the number of possible tests, and the pressure to succeed is intense. The biggest challenge is that the testing material, such as blood, differs from person to person. Establishing a standard process is therefore difficult. A well-known pharmaceutical company had a license to manufacture a product, but cannot bring it to market because it does not work the same way in all people. There are companies that are already successful with cell and gene therapy, but there is definitely room to expand in this area.
Hardware at pharmaceutical and biopharmaceutical companies must become intelligent and the process must become more predictive. In practical terms, this means that plants must be digitalized. Bilfinger helps its customers do just that.
Professor Christoph Herwig, Vienna University of Technology
Companies must optimize their methods in development and production, and manufacturing must become more predictive. It is important to determine which products are suitable for which patient groups. To do this, data from individual batches must be collected, combined, evaluated and made available as platform knowledge as early as the development phase.
Companies also need to do a better job of analyzing their processes. They need a stable process if they are to obtain a good-quality end product. The quality of the raw material must be measured so that the production process can be adjusted more precisely.
Time-to-market is also a decisive factor, which means shortening the process development time and thereby increasing productivity. Whoever gets to the market fastest is the winner, as currently demonstrated by the race for the development and approval of COVID-19 vaccines.
Bilfinger is there to help pharmaceutical and biopharmaceutical companies make the best possible use of their facilities. Plants are best used when production is continuously improved - already during the manufacturing process. But there is one condition: the customer’s hardware must become intelligent, meaning that a plant module must be linked to a digital solution. This is made possible, for example, using Bilfinger’s Qubicon® software. It enables customers to significantly improve the effectiveness of their process development. In the future, product quality will be ensured during the manufacturing process through the application of mathematical models.
Another possibility for better plant utilization is the digital twin that Bilfinger offers its customers. In addition to the real plant, there is a digital image that runs in real time parallel to the actual process. Maintenance and production data are combined via the digital platform and evaluated in a forward-looking manner. The data can be used to identify where there is potential for using the plants more efficiently. Digital twins have great promise and could also be used for cell and gene therapy.