热原检测
热原检测是确保注射药品和医疗器械安全性的关键步骤，现已纳入医疗制品的强制性放行检测，以避免热原物质诱导的致命发热反应。单核细胞活化试验(MAT)可通过一次体外试验同时检测内毒素和非内毒素热原。
概要
单核细胞活化试验(MAT)
MAT可同时检测药品和医疗器械等注射用品中的内毒素和非内毒素热原，遵循监管准则，可作为传统动物试验的体外替代方法。
家兔热原试验和鲎试剂(LAL)试验广泛用于热原检测。两种方法都使用动物且有一定的局限性。家兔热原试验因动物反应与人体反应的巨大差异而缺乏稳定性。而鲎试验法又只检测内毒素，忽视所检样品中可能存在的非内毒素热原而带来安全风险。
为了克服这些局限性，单核细胞活化试验(MAT)被2010版欧洲药典采纳，取代家兔热原试验成为新的药典方法（EP 2.6.30章节），FDA行业指南同样也提及这一检测法。
请注意：欧洲药典委员会(European Pharmacopoeia Commission)根据3Rs原则，决定停用家兔热原试验，认为MAT是最佳的替代选择。
阅读文章并与我们的专家进一步讨论来开始行动。
- 符合国际法规和准则： 减少动物试验数量，与行业和监管部门的伦理趋势步调一致。
- 标准化反应性和高灵敏度(LOD 0.05 EU/mL)。便利的即用型细胞系，减少了繁重的实验室工作，无需细胞培养实验室参与。
- 合格细胞： 人急性单核细胞(Mono-Mac-6)不仅在MAT国际验证中有提及，还经检验可表达所有表面Toll样受体(TLR)，因而保证了热原检测范围广度。
了解更多有关非内毒素热原阳性对照的信息。
如需了解非内毒素热原阳性对照的详情，请点击此处。
- 大范围的热原检测： 同家兔热原试验(RPT)一样，MAT可同时进行有效的内毒素和非内毒素检测。
- 可检测产品范围扩大：RPT、细菌内毒素试验(BET)和LAL这些最常使用的方法检测的产品类型有限，MAT在应用灵活性更高。
- 模拟人免疫反应的体外检测： 减少动物消耗量的稳定可预知模型。
- 符合国际法规和准则： 减少动物试验数量，与行业和监管部门的伦理趋势步调一致。
- 8个供体混合的冻存血：最大限度避免与人的热原免疫反应。
利用我们的服务优化或简化您的热原试验方法，轻松开展验证和高成本效益试验。
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- 验证服务
- 培训服务
家兔、LAL和MAT热原检测方法对比 |
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缺乏用于MAT实施和验证的资源。我们来为您准备！
请与我们的热原检测专家联系，就支持您的热原检测实施的可行性研究、方法开发、验证和培训服务进行讨论。
相关产品资源
- Brochure: PyroMAT® and PyroDetect
Used to detect a broad range of pyrogens in parenteral products such as pharmaceuticals, biopharmaceuticals or medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
- Article: Pyrogen Contamination Risk by Dr. Tim Sandle
Unlike the LAL test, the MAT is a powerful in vitro test for the detection of both endotoxin and non-endotoxin pyrogens (NEPs) acting via the toll-like receptors (TLRs) pathway.
- Data Sheet: Validation Method - PyroMAT® System
The Monocyte Activation Test (MAT) was introduced in the European Pharmacopeia (Chapter 2.6.30) in 2010, as a compendial method that can be used to replace the Rabbit Pyrogen Test (RPT).
- Infographic: MAT Implementation Workflow
Implementation of our Monocyte Activation Test (MAT), the PyroMAT® system.
- Poster: Pyrogen Detection in Pharma QC: Moving Away from the RPT
We have demonstrated that the MM6 cells are suitable for the detection of various NEPs targeting different monocytic toll-like receptors, making MM6 cell line-based MAT suitable for RPT replacement.
- Application Note: Detection of NEP by MAT Using the PyroMAT® System
The monocyte activation test (MAT) is the human in vitro alternative to the rabbit pyrogen test, and allows the detection of the full range of pyrogens, including endotoxins and non-endotoxin pyrogens (NEPs).
- Application Note: Detection of Pyrogens in Vaccines with PyroMAT® System
The PyroMAT® System uses cryo-preserved Mono-Mac-6 (MM6) human monocytic cells as a source of monocytes. The response to pyrogenic substances is determined by measurement of Interleukin-6 (IL-6) produced by the MonoMac 6 cells.
- Questions & Answers about MAT. Dr. Tim Sandle Reponds
Risk considerations for the presence of pyrogens and the need for the MAT test in pharmaceutical processing.
- White Paper: Monocyte Activation Test
In this context, the in vitro pyrogen test based on human cells offers a valuable alternative to the rabbit pyrogen test.
- Application Note: Detection of Pyrogens in Hormone-based Drugs
For the quantification of the pyrogenic load of a sample, method A in accordance with the European Pharmacopeia can be conducted.
- Application Note: Detection of Pyrogens in FBS with PyroMAT® System
The response to pyrogenic substances is determined by measurement of Interleukin-6 (IL-6) produced by the Mono-Mac-6 cells. For this purpose, the ELISA-microplate supplied in the kit is coated with an antibody specific to IL-6.
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