Marketing authorisation of recombinant antibodies and antibody derivatives, immunoglobulins, and antisera as well as testing batches of biomedicines – the Immunology Division provides regulatory support for the entire life cycle of these drugs. The division’s experts are in demand for scientific advice – nationally at the Paul-Ehrlich-Institut as well as at the European Medicines Agency (EMA) – and are represented on a large number of European committees at the EMA and the European Directorate for the Quality of Medicines (EDQM).
The Immunology Division’s research group studies cellular and molecular immunobiology as well as the immunological safety of biomedicines.
As a scientific service for experimental research at the Paul-Ehrlich-Institut (PEI), the division operates different infrastructure platforms.
This section handles clinical questions regarding regulatory procedures for antibody-containing medicinal products such as immunoglobulins, polyclonal and monoclonal antibodies (mAbs), and antidotes. It evaluates the clinical data and studies of these drugs in the context of national and European authorisation procedures and in applications for approval of clinical trials. The section advises applicants on clinical issues in the development of the above-mentioned medicinal products. Numerous new mAbs for the treatment of cancer or autoimmune diseases are in development, and the section is involved in one-third of all authorisation procedures for mAbs as rapporteur or co-rapporteur for the Committee for Medicinal Products for Human Use (CHMP) at the EMA. In addition, its experts work on committees at the EMA Secretariat (e.g. Oncology Working Party (ONCWP), Scientific Advice Working Party (SAWP)) to help with tasks such as developing guidelines.
This section deals with all aspects of manufacturing and manufacturing process control of antibody-containing medicinal products such as immunoglobulins, monoclonal antibodies, and antisera. In addition, it handles non-clinical issues regarding regulatory procedures in the context of national and European authorisation procedures and in applications for approval of clinical trials. Particular importance is attached to the non-clinical evaluation of applications for approval of clinical trials of investigational medicinal products for first-time use in humans. Another important task is to advise pharmaceutical companies and academic applicants in the run-up to clinical trials and marketing authorisation, both at the national and European level. In addition, experts are involved in committees of the EMA (e.g. Biologics Working Party (BWP), Non-clinical Working Party (NcWP), Biosimilar Medicinal Products Working Party (BMWP), Methodology Working Party (MWP)). At EDQM, they are involved in working parties such as the Monoclonal Antibodies Working Party (MAB Working Party), P4Bio Working Party, Biosimilar Working Party, and Group of Experts 6B. Its experts actively participate in the preparation of guidance documents and monographs. They accompany inspections of manufacturing sites by the monitoring authorities as experts.
This section performs chemical, biochemical and physicochemical analyses as well as potency and purity tests of biomedicines in the laboratory. It tests batches of antibody-containing medicinal products products and is responsible for official batch release both nationally and EU-wide. The experts in this section develop new testing methods and improve existing ones, conduct research accompanying tests, represent the Paul-Ehrlich-Institut in working groups of the EDQM, and teach at the Goethe University Frankfurt/Main and the Technical University Darmstadt. Interlaboratory comparisons, post-marketing surveillance studies, and experimental testing of centrally authorised products (CAP) are also part of their tasks. In addition, tests are carried out for institutions such as the German Armed Forces or emergency pharmacies. Members of this section accompany inspections of manufacturing sites by the monitoring authorities as experts.
This section coordinates and approves clinical trial applications. It evaluates the applications formally and in terms of content in cooperation with the sections responsible for the product authorisations – and advises applicants (sponsors) during and after the application process. The experts in this section work on the annual safety and results reports for clinical trials. The administration of the European databases for clinical trials, EudraCT and CTIS, is also handled by this section. Furthermore, non-interventional studies and compassionate use programmes are processed and published and participants in clinical trials and their relatives receive advice.
The research projects of the Research Immunology Section make an important contribution to the expertise of the Paul-Ehrlich-Institut, which allows Institute experts to provide a high-quality evaluation of novel biomedical therapeutic strategies and innovative pharmaceutical treatment approaches in a wide range of immunological fields.
Updated: 03.07.2023
