The Paul-Ehrlich-Institut (PEI) is the German Federal Institute for Vaccines and Biomedicines. It is responsible for human and veterinary biomedicinal products (pursuant to Section 77 AMG [German Medicines Act]) including blood and tissue products. Official duties comprise the authorisation of clinical trials, processing of applications for marketing authorisations in the various national and European procedures. Furthermore, the PEI conducts official testing and batch-release of the medicinal products, is responsible for their safety and provides information for patients and consumers. Due to the expertise in regulatory affairs and quality management, the PEI also gives advice for national, European, and international target groups concerning the assessment of risks and the development of guidelines.
In addition, the PEI possesses its own research departments in the fields of immunology, allergology, bacteriology, biotechnology, haematology, transfusion medicine, veterinary medicine, and virology.
Professor Dr Zoe Waibler is the deputy director of the immunology department and head of the section “Product Testing of Immunological Biomedicines”. As partner of this project, she and her team will contribute with her expertise in basic and translational research, specialised in the field of immunology. Her research focusses on viral infections, early immune responses, and immunological mechanisms underlying severe adverse effects of biopharmaceuticals such as TGN1412 or factor VIII products, the latter being used for the treatment of haemophilia A patients.
The priority of the PEI within this project is to improve the safety of biopharmaceuticals and to account for a better understanding of modes of actions and mechanisms of immunotherapies.
Role within Project
- Coordination of various project parts
- Actively support the work packages dealing with innovative models for immune-inflammatory disease therapeutics and immune oncology models
- Develop, analyse, and obtain in vitro activation models (including immune cells and further relevant cell types reflecting the clinical/pathological context) in order to predict immuno-safety of biopharmaceuticals using TGN1412 and OKT3 as positive controls for cytokine release syndrome scenarios