The Infectology Division is responsible for the authorisation and batch testing of human vaccines. This division includes the sections of Clinical Assessment, Quality Assessment, Product Testing, Viral Safety, Microbiological Safety, and Research, as well as the supply shortage management team that reports directly to division management. The experts in the Infectology Division are in demand for scientific advice – on the national level for applicants from the pharmaceutical industry and academia and as members of national committees as well as at the European Medicines Agency (EMA). They are highly regarded by members of their field and are represented on numerous European committees at the EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM).
This section evaluates the preclinical and clinical data of vaccines against viral, bacterial, mycotic, and parasitic infections and data from BCG preparations for immunotherapy in the context of marketing authorisation procedures (centralised, decentralised, national), life cycle management, and clinical trials. This work also includes active participation on the EMA's Paediatric Committee (PDCO) and Emergency Task Force (ETF).
This section evaluates the quality of vaccines against viral, bacterial, mycotic, and parasitic infections and of BCG preparations for immunotherapy in the context of marketing authorisation procedures (centralised, decentralised, national), life cycle management, and clinical trials. Additionally, experts from this section work on national and international committees, e.g. the EMA Biologics Working Party (EMA BWP).
This section is responsible for testing and releasing batches of human vaccines against viral, bacterial, mycotic, and parasitic infections. It carries out the experimental tests laid down in the European batch testing guidelines. Independent, federal batch testing guarantees consistent quality and effectiveness of vaccines. The section is involved with the WHO Collaborating Center for Vaccines.
Scientists in this section evaluate the safety of biomedicines and clinical investigational medicinal products with regard to viruses and prions. Another important task is to advise pharmaceutical companies and academic applicants on questions of viral safety in the run-up to clinical trials and marketing authorisation procedures at both the national and European levels. Deviations in medicinal product production are assessed with regard to their effects on the viral safety of the medicinal products and possible transmission cases are clarified. The section conducts research on methods of inactivation or separation of viruses, the selection of model viruses required for this purpose, and the development of novel, improved viral detection systems such as metagenomic high-throughput sequencing (next generation sequencing). The Viral Safety Section actively participates in national and international expert committees, e.g. the German National Advisory Committee Blood (AK Blut).
The Microbiological Safety Section tests the pyrogen levels and sterility of medicinal products. Since the defined parameters cannot always be achieved for biomedicines, innovative concepts are being developed to minimise potential infection risks. A central task is the evaluation of these microbial safety concepts in the context of applications for authorisation or the approval of clinical trials of advanced therapy medicinal products (ATMPs) and tissue preparations. This section tests medicinal product batches for pyrogenicity and endotoxins, tests rapid microbiological methods for short shelf life biological medicinal products, and develops bacterial standards for microbiological quality testing of blood products and tissue transplants. The section is involved in national and international committees, e.g. AK Blut.
The scientists in this section support regulation in the areas of microbiological vaccines and microbiological safety through their research projects on immune-based antibacterial therapies, vaccine development against antibiotic-resistant bacteria, and method development in the field of batch testing. In addition, they carry out research projects in the field of marketing authorisation (regulatory research) as well as in cooperation with the other sections in the "Infectology" division.
Updated: 19.05.2025
