About Pooled PBMCVIEW PRODUCT LISTING
Pooled PBMC are prepared for use in the monocyte activation test (MAT) for pyrogens. The MAT is intended to replace the use of rabbits and horseshoe crabs in testing pharmaceuticals for substances that can cause fever. In 2010, the European Pharmacopoeia published guidelines for the MAT describing the requirements for blood donors and cells. They recommend pooling cells from at least four donors (preferably eight) to reduce the effects of donor variability.
Our PBMC pools are prepared from four healthy donors, which can be used alone or combined with a second pool to reach the recommended eight donors. We test each pool for its ability to detect a certified endotoxin standard and show the cytokine output is directly related to the concentration of endotoxin. The pool also responds to polyinosinic:polycytidylic acid (poly I:C), an analog of double-stranded RNA that does not contain bacterial endotoxin. The MAT detects other non-endotoxin substances that can cause febrile reactions, which is a major advantage over the Limulus amebocyte lysate (LAL) test.
We recommend that your lab further validate the use of these pooled cells for use in your system as described in the European Pharmacopoeia chapter 2.6.30. Also refer to the FDA guidance on pyrogen and endotoxin testing.