Topic: Quality control of vaccines, Airborne pyrogens
Test Method Number:
TM2016-06 (BRA)
Short Name of TM:
MAT
Year received:
2016
Responsible Organisation:
Method Description
MAT is intended to determine pyrogenic contamination of injectable products. The aim of this activity is to demonstrate new appplications of MAT, such as, its use on biological products (hyperimmune sera, vaccines, blood products), medical devices, nanomaterials and Non-Endotoxin Pyrogens (NEPs). Once demonstrated, this test may replace Rabbit Pyrogen Test (RPT) or enter together wit Bacterial Endotoxin Test (BET). In this last case, since BET is negative, it is needed to perform MAT. If BET is positive, then, stop.
The assay is based upon the Human mechanism of fever. The products is kept in contact with human blood and the cytokines (IL-1b and/or IL-6) are measured by commercial ELISA,
Track Approval Status
-
Submission
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Validation
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Peer-review
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Recommendation
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Regulatory acceptance/Standards
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