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The Indian Pharmacopoeia Commission (IPC) scientists recently visited Brussels, Belgium to attend two days Symposium on “Pyrogen testing 2.0: Ethical. Evolving and Eco-friendly” for implementing safe, rapid, state-of-the art and sustainable non-animal testing in medicines.
The Symposium held at Albert Borschette Conference Centre (CCAB) was jointly organized by European Directorate for the Quality of Medicines & Health Care (EDQM) and European Partnership for Alternative Approaches to Animal Testing (EPAA).
Animal free pyrogenicity testing, such as the Monocyte Activation Test (MAT), is a modern, in vitro method used to detect fever-causing contaminants (pyrogens) in drugs and medical devices without using laboratory animals. It simulates human immune responses using human blood cells, providing better accuracy and compliance with ethical standards than traditional rabbit tests.
During the event, officials from IPC updated on the implementation of the Rabbit Pyrogen Test (RPT) phase-out strategy across Europe, explored the challenges and solutions encountered during the transition to MAT, explored the status of recombinant reagents for use in the bacterial endotoxins test (BET).
IPC scientists also updated on how other pharmacopoeias and regulatory frameworks outside Europe have adapted in response to the European Pharmacopoeia (Ph. Eur.) initiative, got perspectives from regulators, industry, and international stakeholders on the future of animal-free pyrogenicity testing.
Key outcomes for IPC in the symposium are to include a concept on “Recombinant reagents for BET” as a guidance in Indian Pharmacopoeia (IP) for its future adaptation by Indian pharmaceutical industries for implementing safe, state-of-the-art and sustainable non-animal approaches to replace RPT.
Dr Anil Kumar Teotia, senior principal scientific officer, Dr. Prasad Thota, scientific officer from Microbiology Department of IPC participated in the two days Symposium. More than 100 delegates participated from 30 countries across the world in this symposium.
Animal free testing includes tests like MAT among others. MAT test mimics the human fever response. It uses human blood cells (monocytes) which release cytokines (fever markers) when exposed to contaminants, providing a more relevant human safety assessment.
The advantages of these tests over animal methods are that they detect a broader range of pyrogens (both endotoxin and non-endotoxin) and acts as a better indicator for human fever responses compared to rabbits. These tests eliminate the use of animals such as rabbits and align with the 3Rs concept (Replacement, Reduction, Refinement). They also reduce the rate of false results associated with animal test variations.
The European Pharmacopoeia is actively phasing out the RPT in favour of the modern and safe alternatives by 2026.
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