Herceptin Binding Assays

BioOutsource has extensive experience in the development, optimization and validation of a wide range of different types of bioassays and binding assays for Herceptin and offers GCP, GLP and cGMP 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 Herceptin Her2 binding assay, Herceptin C1q binding assay, Herceptin FcRn binding assay and Herceptin Fc-Gamma Receptor binding assays to support characterization, comparability and biosimilarity studies.

Binding assays are employed to study a number of different features of Herceptin (trastuzumab) and play a vital role in the development process and characterization and comparability studies, measuring the association and dissociation of Herceptin (trastuzumab) to Her2/neu 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 Herceptin (trastuzumab) and performance of extensive comparability studies:

These methods have been developed using different platforms including ELISA, and 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 comprehensive, industry-leading comparability reports to understand all aspects of the performance of your Herceptin molecule.

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

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