FSL-1 Non-Endotoxin Pyrogen (NEP) Control

FSL-1 is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT^® system.Non- Endotoxin Pyrogen (NEP) Control FSL-1 is a synthetic lipoprotein derived from Mycoplasma salivarium, supplied in a lyophilized form. FSL-1 Non- Endotoxin Pyrogen (NEP) Control activates TLR2/TLR6 receptor of monocytes and is used as a positive control for PyroMAT^® system. The response to pyrogenic substances is determined by measuring the Interleukin-6 (IL-6) produced by the monocytes using ELISA microplate.

FSL-1 control can be used as a positive control with the PyroMAT^® System. It is to be used for Product Specific Validation (PSV) and routine testing to show that the system can detect non-endotoxin pyrogen contaminants in pharmaceutical products.

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany