Simponi L929 Neutralisation Assay

The primary mechanism of action of Simponi is the neutralization of circulating TNF-Alpha. TNF-Alpha itself is involved in an array of different signalling pathways and through binding to TNF-Alpha, Simponi has the capacity to neutralize the wide range of different biological activities that are mediated by TNF-Alpha. Historically, anti-TNF-Alpha therapeutic antibody products have used a murine cell line (L929 or WeHi) with a cell death endpoint as the primary potency bioassay.

The principle of the Simponi (golimumab) neutralization bioassay is that the relevant cell line is prepared in cell plates. A dilution series of golimumab is then prepared and added to an optimized concentration of TNF-Alpha and incubated to allow neutralization to occur, prior to addition to the cell plate. The cell plate is then incubated for a further period of time before the assay is completed using the relevant detection methodology. Sample results are routinely reported as a relative potency measurement against the reference standard.

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