WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices (IVD) Designated for Sixth Time

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The WHO Collaborating Centre receives annual financial support for its work from the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It will continue to focus on the following areas:

• The development of biological standard materials (International Biological Reference Preparations, IBRP) as well as participation in corresponding collaborative studies. IBRP are crucial for the development and standardisation of numerous biological and immunological tests (in vitro diagnostic medical devices, IVDs). These are used to diagnose diseases and for the quality assurance of medicinal products of biological origin – including blood-based products, vaccines and antibodies.
• Participation in the preparation of WHO Guidelines and Recommendations.

The WHO Collaborating Centre’s Role in the "Non-Endotoxin Pyrogen Reference Reagents" Project

As part of an cross-departmental cooperation within the Institute, the Microbiological Safety Section in the Infectious Diseases Division is developing non-endotoxin pyrogen reference reagents (NEP reference reagents) for the monocyte activation test. This work is carried out in collaboration with the National Institute for Biological Standards and Control (NIBSC, UK) and the European Directorate for the Quality of Medicines and HealthCare (EDQM).

The monocyte activation test is used to detect fever-causing substances (pyrogens) in medicinal products. The test uses human whole blood, which can help to replace animal experiments (in vitro method).

The WHO Collaborating Centre’s Role in the Achilles Project

Another focus of the cooperation is the centre's participation in the WHO's Achilles project. The aim of this project is to improve access to safe plasma protein products (PPPs) in Low and Middle Income Countries (LMICs). The initiative supports the introduction of suitable production technologies, promotes sustainable implementation, and aims to reduce supply gaps in PPPs in LMICs. The project has already been successfully implemented in South Africa and Indonesia and is currently being implemented in Senegal and Ethiopia. More countries are to follow.

Support for Blood Regulation Tasks

Experts from the Paul-Ehrlich-Institut also support WHO in assessing national blood regulations using the WHO Global Benchmarking Tool plus Blood (GBT plus Blood). They also contribute to training measures to help others learn how to apply the tool correctly.