In June 2021, the European Pharmacopoeia Commission (EPC) took the decision to begin a process that will culminate in the rabbit pyrogen test (RPT) being completely replaced in the European Pharmacopoeia (Ph. Eur.) within approximately 5 years.
This decision affects several Ph. Eur. texts covering a wide range of fields – from vaccines for human use to blood products and antibiotics; from radiopharmaceuticals to containers – and the EPC has committed to replacing the RPT with a suitable in vitro alternative in all of them.
This international event, jointly hosted by the EDQM (Council of Europe) and the European Partnership for Alternative Approaches to Animal Testing (EPAA – European Commission), sets out how the Ph. Eur. is phasing out the RPT from its texts after 50 years of use.
It reveals how scientific progress has delivered new and humane methods such as the in vitro monocyte-activation test (MAT) and how the pharmaceutical world has successfully navigated the transition from the RPT to the MAT and dealt with the challenges encountered along the way.
Participants have the opportunity to improve their hands-on skills at a training session on the MAT, which includes open discussions, case studies and information on troubleshooting solutions.
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This event is of interest to professionals from the pharmaceutical and biopharmaceutical industries, contract laboratories and authorities.
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Conference, 14-15 February:
- Opening session
- In-depth exploration of the monocyte-activation test (MAT)
- Pulling the rabbit out of the hat: Industry perspectives
- Regulatory Session: So what will rabbit-free pyrogen testing look like in Europe? How about the rest of the world?
A recording of the live event is available: HERE
Training session, 16 February:
- Qualification of Peripheral Blood Mononuclear Cells (PBMCs)
- Freezing and thawing of PBMCs
- Cell handling in the MAT assay
- Readout options
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