Enbrel TNF-Alpha Binding Assays

BioOutsource offers a range of off-the-shelf Enbrel TNF-Alpha binding assays to support Enbrel biosimilar manufacture, process development, characterisation and comparability studies. We offer industry leading Enbrel comparability and Enbrel characterisation services and can be adapted for your product, if required.

Enbrel (etanercept) mediates its activity through the interaction with TNF-Alpha. Enbrel (etanercept) binds this protein with high affinity and mediates a number of different outcomes including neutralisation of cell death, apoptosis and expression of adhesion molecules as well as recruitment of the effector cells of the immune system. Therefore, TNF-Alpha binding by Enbrel, as with all antibody-antigen interactions represents one of the key quality attributes of the Enbrel (etanercept) molecule.

TNF-Alpha binding assays can be performed using a wide variety of different assay platforms and on each platform, these TNF-Alpha binding assays can be conducted using different binding assay designs. BioOutsource has developed the following Enbrel TNF-Alpha binding assays:

Enbrel TNF-Alpha Binding ELISA by Electrochemiluminescence (MSD)

BioOutsource offers Enbrel TNF-alpha binding assays using an upgraded version of the traditional ELISA on the Mesoscale Discovery (MSD) platform to report the relative binding of biosimilar and innovator Enbrel material as a percentage of a designated reference lot with comprehensive parallelism assessments. BioOutsource works closely with our clients and can adapt this method for performance as a traditional ELISA platform to support lot release of product at contract manufacturing facilities, where required. The assay can be performed using recombinant TNF-Alpha or cells that have been engineered to express TNF-Alpha on the cell surface.

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