Humira Binding Assays

BioOutsource has extensive experience in the development, optimization and validation of a wide range of different types of binding assays and immunoassays and offers GCP, GLP and cGMP-compliant testing services in compliance with EMA and FDA guidelines to support the biopharmaceutical industry.
Using this experience, we have created a range of off-the-shelf binding assays, including Humira TNF-Alpha binding assay, Humira C1q binding assay, Humira FcRn binding assay and Humira Fc-Gamma Receptor binding assays to support process development, characterisation and biosimilarity studies.

Binding assays are employed to study a number of different features of Humira (adalimumab) and play a vital role in the development process and characterization and comparability studies, measuring the binding of Humira to TNF-Alpha as well as C1q, the Fc Gamma Receptors (FcR) and the neonatal Fc Receptor (FcRn). BioOutsource offers a comprehensive range of off-the-shelf generic binding methods to support the characterization of Humira (adalimumab) and performance of extensive comparability studies:

These methods have been developed using different platforms including ELISA, Electrochemiluminescence (MSD) or Surface Plasmon Resonance (SPR) and can be performed with a variety of different reporting mechanisms including affinity, on and off rates as well as relative binding using a totality of data evaluation approach to provide you with the comprehensive, industry-leading comparability reports required to understand all aspects of the performance of your Humira molecule.

BioOutsource offers cost-effective solutions to develop custom methods that are not currently in our portfolio please contact us to find out more.