The Paul-Ehrlich-Institut (PEI) is the German Federal Institute for Vaccines and Biomedicines and reports to the German Federal Ministry of Health (Bundesministerium für Gesundheit). It is a senior federal authority in the field of medicinal products providing services in public health.
The PEI assesses and monitors vaccines and biomedicines to ensure that all biomedicines available on the German and European markets have a favourable benefit-risk-ratio. These activities include the assessment of documents submitted, as well as experimental tests, such as batch release testing, and on-site inspections of manufacturing facilities. The PEI assess and monitors the benefit-risk balance before, during and after the marketing authorisation of biomedicines for human use and immunological medicines for veterinary use.
The PEI's own experimental research in the field of life sciences is an indispensable basis for the fulfilment of its duties.
Role of PEI in VAC2VAC:
In the VAC2VAC project, the research focus of PEI's involved groups is on Diphtheria-, Pertussis-, Tetanus- and Leptospira vaccines.
In a proteomic approach, a combination of liquid chromatography and mass spectrometry will be applied to tetanus toxoid and to an array of antigens from seed material to the final vaccine product of Leptospira vaccines.
In a cell-based assay, peripheral blood mononuclear cells will be used to quantify and characterize vaccine-induced activation of human B cells in response to a new vaccine batch. This response will be measured for example as proliferation or immunoglobulin production by means of flow cytometry, ELISpot or BrdU incorporation. The goal is to evaluate the feasibility and applicability of this approach for batch release consistency testing, especially assessing batch potency.
PEI will also contribute to elaborate guidance documents on validation and implementation strategies of the newly developed methods. Regulatory experts will be involved at all stages of discussion of data.
Dr. Elisabeth Balks is leader of Work Package 1. With 18 years of experience in OMCL batch control, she is responsible for the evaluation of alternative testing methods in "Product testing of Immunological Veterinary Medicinal Products". She has an active role in numerous collaborative studies and 3R research projects.