When you need to be sure
Monocyte Activation Test (MAT) for Pyrogen Detection
Accurate and Sustainable Non-Animal Testing
Within the global pharmaceutical and biotech industries, drug and medical device development are on the rise while stricter regulatory and sustainability requirements are being enforced to demonstrate product quality and safety. To this end, SGS offers in-vitro monocyte activation testing for organizations seeking accuracy in pyrogen detection that incorporates both precision and ethics. The European Pharmacopoeia Commission's announcement of phasing out the traditional in-vivo rabbit pyrogen test (RPT) in favor of non-animal methods is also an indicator of future requirements that might be implemented in North America. SGS is ready, now and in the future, to conduct the critical testing needed to ensure that your products are safe for human use.
Supports Regulatory Compliance
- Recognized and accepted by regulatory bodies worldwide including the European Medicines Agency (EMA), the European Pharmacopoeia Commission (EPC), the European Centre for the Validation of Alternative Methods (ECVAM) and the U.S. Food and Drug Administration and Health Canada.
- European Pharmacopoeia 2.6.30 recognizes MAT as a compendial method.
- EMA encourages MAT for product classes where RPT may fall short.
- USP <151>, <1085>, <1041> references MAT under certain product categories and conditions.
The MAT Method & Its Benefits
- The Monocyte Activation Test (MAT) is a non-animal, in vitro assay method that detects a wide range of pyrogens using human immune cells; it mimics the human fever response far more accurately than animal-based tests.
- It detects both endotoxin and non-endotoxin pyrogens — offering broader coverage than competing test methods.
- It utilizes human-relevant biology, improving clinical relevance.
- It is animal-free, aligning with sustainability and ethical standards in accordance with the 3Rs principles (Replace, Reduce, Refine).
- It is more scalable, sensitive, and suitable for biologics, vaccines, and cell and gene therapies.
The SGS Difference
- World’s leading testing, inspection, and certification and company.
- Over 40 years serving the global pharma industry, and the biotech industry since its inception.
- Global network of 2,700 labs with strong North American presence.
- Flexible testing formats and rapid turnaround.
- Experts help develop and validate global testing methods.
- Top 1% in 2025 S&P Dow Jones Sustainability Yearbook.
- Recognized by TIME and Statista in 2024 & 2025 for sustainability leadership.
- Ethical and sustainable testing solutions.
- Trusted global reputation that supports international market access.
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Reach Out to Your Local SGS Team to Get Started
