Herceptin Her2 Binding Assays

BioOutsource offers a range of off-the-shelf Herceptin Her2/neu binding assays to support Herceptin biosimilar manufacture, process development, characterization and similarity studies. We offer industry leading Herceptin comparability and Herceptin characterization services and these can be adapted for your product, if required.

Herceptin (trastuzumab) mediates its activity through the interaction with the Her2/neu protein. Herceptin (trastuzumab) binds this protein with high affinity and mediates a number of different outcomes including inhibition of receptor dimerization, inhibition of growth as well as recruitment of the effector cells of the immune system. Therefore, Her2 binding by Herceptin, as with all antibody-antigen interactions, represents one of the key quality attributes of the Herceptin (trastuzumab) molecule.

Her2 binding assays can be performed using a wide variety of different assay platforms and on each platform, these Her2 binding assays can be conducted using different binding assay designs. BioOutsource has developed the following Her2 binding assay:

Herceptin Her2 Binding by SPR using Biacore T200

BioOutsource has improved the traditional Herceptin Her2 binding ELISA and offers an enhanced Her2 binding assay that significantly increases the understanding of the Herceptin-Her2 binding during comparability studies. We are pleased to offer the Herceptin Her2 binding assay using surface plasmon resonance with the Biacore T-200 reporting full kinetic analysis including Affinity Constants (KD), with the association or “on” rate (Ka) and dissociation rate or “off” rate (Kd) . The data is also evaluated to generate relative binding and parallelism assessments.

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