The Research Center Pharmaceutical Engineering (RCPE GmbH) in Graz is working on a concept to make Europe less dependent on global supply chains. In this interview, Caroline Schober, Chief Strategy Development and Communications Officer, explains the idea of emergency production of medicines – and what role politics and the army play in this.
Ms. Schober, what exactly is the RCPE and what are you working on?
The RCPE is a non-profit limited liability company owned by Graz University of Technology, the University of Graz and Joanneum Research. We are a so-called K1 competence center, which is funded by the federal and state governments via the FFG and SFG respectively, but mainly works together with corporate partners. We don’t develop new active substances, but take care of the next step: How an active ingredient is brought into a functioning dosage form – such as a tablet, liquid or inhaler. We deal with both the formulation and the necessary process technology and production methods.
What central problem does the “emergency production” project address?
The aim is to enable self-sufficient production of medicines in crisis situations – such as pandemics or supply bottlenecks – and a research pilot plant already exists. Production could even take place underground in a small space. We are concentrating on two technological approaches: Firstly, the long-term storage of active ingredients in so-called “smart storage containers”, which keep the active ingredient stable for decades. Secondly, so-called “continuous manufacturing” technology – continuous production that can be flexibly ramped up when there is demand. This allows millions of tablets to be produced in relatively small, energy-efficient plants within a few weeks.
Why is such emergency production necessary at all?
Europe is heavily dependent on Asia for active ingredients. Around 70 percent of active ingredients come from China or India, and around 80 percent of raw materials. Even in normal times, there are regular supply shortages, with around 500 medicines currently missing every year in Austria alone. This leads to chronic shortages, especially for vital medicines such as antibiotics, painkillers and blood pressure medication – a situation that is dramatically exacerbated during crises. At the same time, there is a lack of legal and organizational foundations for reacting quickly in an emergency – for example with regard to approvals, packaging rules or the use of common European stocks.
What are the challenges of implementation?
Emergency production must be professionally prepared in technical, personnel and legal terms. It is not just about technology, but also about responsibilities and structures. Such a facility must be operated under “Good Manufacturing Practice” (GMP) conditions, i.e. under the very high standards of drug production. This requires trained personnel and “pre-approval” of the production of each drug in advance. The question of who owns such a facility is also crucial: to ensure that it is really available immediately in an emergency, it would have to be operated by the public sector – anything else would be too risky. Politically, it also needs to be clarified when an “emergency” actually exists and who decides on the launch. Last but not least, even a compact plant with an area of around 400 square meters requires a stable power supply, water and air purity. In a blackout scenario, an emergency power generator would have to be available to maintain the sensitive process parameters precisely.
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What role could the armed forces play in this?
The Austrian Armed Forces have experience in logistics, infrastructure and scenario planning. It would therefore be a logical partner – not necessarily for production itself, but for buildings, logistics, organization, security and, if necessary, protection of the facilities. Military thinking in terms of scenarios and redundancies is exactly what has been lacking in the civilian supply of medicines to date. It is in national defense that we see the greatest understanding of the need to set up systems and keep them operational before they are needed.
What happens now?
The current aim is to raise awareness of the existing supply gap and the technical solutions that already exist. The concept has been patented, prototypes exist and interest is growing – also internationally. Now political decisions are needed to turn research into reality. After all, it will take at least three years before an operational plant can produce tablets. So the best time to act is now.
