Humira TNF-Alpha Binding Assays

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

Humira (adalimumab) mediates its activity through the interaction with TNF-Alpha. Humira (adalimumab) 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 Humira, as with all antibody-antigen interactions, represents one of the key quality attributes of the Humira (adalimumab) 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 Humira TNF-Alpha binding assay:

Humira TNF-Alpha Binding ELISA by Electrochemiluminescence (MSD)

BioOutsource offers Humira 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 Humira 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, where required. The assay can be performed using recombinant TNF-Alpha or cells that have been engineered to express TNF-Alpha on the membrane.

Sign-up to receive 3 tips on improving
speed to clinic for biosimilars

Sign-up to receive 3 tips on improving
speed to clinic for biosimilars

* you agree to receive emails with tips, news, insights and quizzes.