The Microbiology division unifies central scientific and regulatory interfaces of the Paul-Ehrlich-Institut (PEI). The microbiological focus includes the marketing authorisation, benefit/risk assessment, batch release testing of microbiological and parasitological human vaccines and the relevant compounds in combination vaccines. An additional focus is the testing of the microbiological safety of tissue preparations and advanced therapy medicinal products (ATMPs) and rapid diagnostic methods. The division has extensive expertise in biostatistics and mathematical modelling (e.g. of infection risks). An on-site inspection team ensures lawful manufacturing, clinical testing and surveillance (vigilance) of biomedicines. Staff members in all areas are involved in committees of the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ensure that regulations are scientifically valid, practicable and up-to-date. They provide scientific advice to applicants on national and European level (EMA scientific advice). The division supports the WHO Collaborating Centres for the “Standardization and Evaluation of Vaccines” and for the “Quality Assurance of Blood Products and in vitro Diagnostic Devices” that are based at the PEI. The division’s research is aimed at improving the development and safety of biomedicines and addressing outstanding questions in infection medicine.
Head of Division’s Research Group
The scientists carry out research related to the immune response to natural infections and to vaccination. Increasing resistance to antibiotics increases the interest in immune-based therapeutic approaches to combating nosocomial infections– but until now they have not been successful. A cross-sectional team is looking into the causes and possible new approaches. The spectrum of activities ranges from post-hoc analysis of clinical trial data to in vitro work with human immune cells to standardisation of preclinical infection models. The division’s researchers are developing standards and methods for continuously improving the microbiological safety testing of vaccines, blood products, tissue preparations and ATMPs – while also responding to current issues in the various sections.
Inspection of Biomedicinal Products Section
The section coordinates the PEI’s inspections and conducts them in collaboration with experts from the various sections. A team of inspectors directs and supports inspections in national and European marketing authorisation procedures, in European certification procedures for plasma master files (PMFs) as well as inspections for auditing pharmacovigilance systems – both nationally and internationally. They carry out site visits to perform checks on the manufacturing of medicinal products, the execution of clinical trials and compliance with pharmacovigilance standards.
Microbiological Vaccines Section
The section handles the marketing authorisation and official batch testing of bacterial and parasitic vaccines, BCG-based immune stimulants and test antigens (tuberculins) at national and European level. The section assesses applications for the approval of clinical trials, and provides scientific advice. The section’s experts provide scientific and regulatory support for the development of candidate vaccines against infectious diseases such as Lyme disease, tuberculosis or malaria, as well as further development of established vaccines, e.g. against pneumococci or meningococci.
Develops methods for the batch testing of vaccines. This includes projects aimed at replacing animal testing with in vitro assays.
Microbiological Safety Section
The section tests for absence of pyrogens and sterility of medicinal products. Since these parameters cannot always be guaranteed in biomedicines, innovative concepts are being developed to minimise the risk of infection. One of the section’s central duties is to assess these microbial safety concepts in applications for the marketing authorisation or approval of clinical trials of ATMPs and tissue preparations. The section controls batches of medicinal products for pyrogenicity and endotoxins, tests rapid microbiological methods for biological medicinal products with a short shelf life, and develops bacterial standards for microbiological quality testing of blood products and tissue transplants.
It investigates the composition of the microbiome and phageome in tissue preparations and the properties of bacterial pathogens in blood products.
The section supports all areas of the PEI with mathematical and statistical expertise. Its diversified work includes the provision of advice to developers and the statistical assessment of clinical trials and marketing authorisation dossiers. The section provides support for the assessment of quality-by-design concepts in manufacturing and quality control, the statistical evaluation of validation studies in batch testing and provides advice on research issues.
The section biostatistics investigates the modelling of biomedical systems in infection medicine, supports regulatory research in batch testing and develops methods for advanced clinical trial designs, data integration and big data analyses.