Remicade TNF-Alpha Binding Assays

BioOutsource offers a range of off-the-shelf Remicade TNF-Alpha binding assays to support Remicade biosimilar manufacture, process development, characterization and biosimilarity studies. We offer industry leading Remicade comparability and Remicade characterization services and these can be adapted for your product, where necessary.

Remicade (infliximab) mediates its activity through the interaction with TNF-Alpha. Remicade (infliximab) binds this protein with high affinity and mediates a number of different outcomes including neutralization 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 Remicade, as with all antibody-antigen interactions, represents one of the key quality attributes of the Remicade (infliximab) 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 Remicade TNF-Alpha binding assay:

Remicade TNF-Alpha Binding ELISA by Electrochemiluminescence (MSD)

BioOutsource offers Remicade 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 Remicade 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 membrane-bound TNF-Alpha.

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