From the marketing authorisation of antibodies, antisera and therapeutic vaccines (tumour vaccines) to the testing of batches of biological and biotechnological medicinal products – the Immunology division oversees the entire lifecycle of these medicinal products.
Its experts are in great demand for scientific advice procedures – on a national level with PEI scientific advice or on a European level with European Medicines Agency (EMA) scientific advice – and are represented in a large number of European committees of the EMA and the European Directorate for the Quality of Medicines (EDQM). A research group in the division investigates cellular and molecular immunobiology and the immunological safety of biomedicines. The division operates several infrastructure platforms as a scientific support for experimental research in the Paul-Ehrlich-Institut (PEI): flow cytometery, light and electron microscopy, the mouse facility and the media kitchen.
Head of Division's Research Group
The research team focuses on the strategies of human pathogens to evade immune control, such as the eukaryotic parasite Leishmania major and the bacterium Chlamydia trachomatis. How do these pathogens manage to infect primary cells of the innate human immune system and multiply – and avoid being destroyed by the immune system? An aspect of particular interest is how these pathogens manipulate specific signalling pathways to their advantage, in particular how they regulate various cell death mechanisms of human immune cells. In another project, researchers are comparing the immunomodulatory properties of both proven and new vaccine adjuvants using an immune cell-based model. Since January 2018, the research group has partnered with the LOEWE Centre DRUID, which aims to characterise potential target molecules for the development of active substances, vaccines and diagnostic devices against poverty-related and neglected infectious diseases.
Product Testing of Immunological Biomedicines Section
The section carries out chemical, biochemical and physico-chemical analyses as well as efficacy and purity testing of biomedicines in the laboratory. It tests batches of antibody-containing medicinal products – in 2018 it released 2,370 batches. The section’s experts develop new test methods, improve existing ones, conduct testing-related research and teach at the Goethe University in Frankfurt am Main and the Technical University of Darmstadt. The section’s duties also include collaborative ring trials, post-marketing surveillance studies and the testing of Centrally Authorised Products (CAP).
Monoclonal and Polyclonal Antibodies Section
The section handles regulatory procedures for antibody-containing medicinal products, such as immunoglobulins, polyclonal and monoclonal antibodies and antidotes. It assesses these medicinal products in the context of national and European marketing authorisation procedures, reviews and approves applications for clinical trials, and advises applicants. A large number of new monoclonal antibodies (mAbs) against diseases such as cancer or autoimmune disorders are reaching the marketing authorisation stage, and the section acts as rapporteur or co-rapporteur for the EMA in one third of all marketing authorisation procedures for mAbs. In 2018, there were 266 applications for the approval of clinical trials for medicinal products with new target molecules, demonstrating that the potential of this product class is far from being exhausted. For example, checkpoint inhibitor antibodies represent a further milestone in the development of medicinal products against a wide range of cancers. In addition, the section’s experts provide support for inspections and draw up guidelines and monographs.
The section combines the division's various service duties. These include the advanced light and electron microscopy platform, the production of solutions and bacteriological media for the PEI and the operation of the mouse facility. The section’s research focuses mechanisms of the adaptive immune system, in particular the homeostasis of T lymphocytes.
Therapeutic Vaccines Section
The section assesses therapeutic vaccines and cell-based medicinal products during centralised European marketing authorisation procedures, in many cases as rapporteur or co-rapporteur. The section is involved in scientific advice procedures and assists in the drafting of EMA guidelines. The section’s experts review documents for the approval of clinical trials and participate in inspections by state authorities – a prerequisite for the granting of a manufacturing authorisation for therapeutic vaccines. The section is also responsible for managing the flow cytometry platform.
- Dr Nicole Keil, CAP Working Group – EDQM
- Dr Jaqueline Kerr, Blood Products Working Party (BPWP), Chair – EMA
- Dr Gabriele Reichmann, Safety Working Party (SWP) – EMA
- Dr Jörg Engelbergs, Pharmacogenomics Working Party (PGWP) – EMA
- Dr Daniela Karra, European Pharmacopoeia: Working Group Monoclonal Antibodies (MAB) – EDQM
- Dr Thomas Hinz, Working Party on Raw Materials for the Production of Cellular and Gene Transfer Products (RCG) – EDQM