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On the project: Global Health Protection Programme: Monograph work on excipients for mRNA vaccines

Claudia Stärk on the importance of excipients and why basic research can be so exciting.

At the BfArM, research activities are closely intertwined with regulatory tasks. They create an important basis for a better understanding of mechanisms of action, minimisation of side effects, or the evaluation of therapeutic concepts. Such complex subjects and correlations are not always easy to understand – especially for laypersons. In order to give us a first glimpse of the intriguing scope of activities and research areas, our researchers will be answering five questions about their work at the BfArM.

In the current interview, Claudia Stärk reports on her doctorate at the BfArM. At the Federal Institute, she is part of the Lab-Train team within the Global Health Protection Programme, GHPP in short. The programme’s aim is to strengthen health systems at regional, national and international level in order to support partner countries worldwide, in particular with regard to the prevention and management of epidemics and pandemics.

The LabTrain project strengthens quality standards for pharmaceuticals in African countries by analysing infrastructure (structure building), training and further education of personnel (training) and developing quality guidelines (monograph work). Claudia Stärk's research focuses on monograph work. She is dedicated to the excipients of mRNA vaccines and is developing new, standardised methods for a monograph.

1. Concisely, for those of us who are not specialists like you: What impact does your research have on our everyday life?

Almost everyone has been familiar with the term mRNA vaccine since the coronavirus pandemic. The mRNA serves as a "blueprint" from which antibodies are subsequently produced in the body. However, the mRNA is so sensitive that it would be directly degraded in the body. It is packaged with excipients, in this case lipids, which our body does not recognise as foreign bodies. The lipids form a protective shell, so to speak, and ensure that the mRNA arrives at its destination and forms antigens with the help of the body's own proteins. These trigger a reaction of the immune system, which in turn leads to the formation of antibodies. I am focussing on these lipids.

The result of my research will be a draft for a monograph that will be published in a pharmacopoeia. Pharmacopoeias are sets of rules that specify how medicines or active ingredients must be tested in order to ensure consistent, standardised quality. Ultimately, monographs affect everyone by protecting the population from falsified medicines and thus increasing therapeutic safety.

Research into new drugs also benefits from this: if there are guidelines for testing certain active ingredients or excipients, these substances can be used more easily in research and development.

2. If nothing else – what should everybody retain from this interview with regard to your research subject?

The important role that excipients play in formulations. They influence the quality and efficacy of the end product. Of course, the active ingredient, in our case the mRNA, takes centre stage as the carrier of the information. But without suitable excipients, the mRNA could not reach its target.

Today, it is already possible to control very precisely where a drug should act in the body. This opens up many possibilities. Lipid excipients in particular play a major role in current drug formulation and research.

3. Considering the wealth of areas and institutions for research: How did you come to this research field, or rather, when did you know "this is IT"?

Studying pharmacy really covers many areas and topics. I have always been fascinated by pharmaceutical technology. This also includes the sub-area of formulation, simply put the packaging of the drug substance. In Marburg, the Chair of Pharmaceutical Technology focussed on nanoparticles and liposomes, among other things. This fuelled my interest in these small drug carriers. I found it fascinating how it works that an active ingredient arrives exactly where it is needed. The BfArM's call for applications was a perfect fit.

4. Working in research at the BfArM: What is different from what you had expected?

I like doing my doctorate here at the BfArM. My project is based in the research department. As part of the LabTrain project, there is close cooperation with the unit "Pharmacopoeia" of Division 4. The cooperation between the divisions is good and I have access to many different devices for my monograph work. The many different research specialisms in the division also make the work interesting: laboratory, databases, AI - it's a good mix of everything. The dialogue between colleagues is not only exciting, but also a great source of support because there are many different professional/ specialist backgrounds.

5. Your favourite researcher in history and why?

Not an easy question indeed. There is an incredible number of exciting topics and corresponding research personalities. Studying in Marburg brought me closer to Emil von Behring. He lived and worked in the city; the Dean's Office of Pharmacy in Marburg is located in the Behring Villa. He was known for his successes in the field of serology, in which he used antitoxins extracted from blood serum as medicines against diphtheria and tetanus.

Further information on the GHPP projects:
GHPP Global Health Protection Programme

Further information on and background of the LabTrain project:
GHPP project LabTrain

Claudia Stärk

Claudia Stärk

During her pharmacy studies at the Philipps University of Marburg, Claudia Stärk got familiar with everyday life in a pharmacy as well as working in research in the pharmaceutical industry. After completing her studies and gaining her licence to practise, she initially continued to work in a pharmacy. However, the pharmacist realised early on that she wanted to pursue a doctorate and go into research in the long term. In 2023, she successfully applied for a doctoral position at the BfArM. Since September of the same year, she has been a doctoral student in the “LabTrain-Team" of the "Global Health Protection Programme" with a focus on monograph work.