Herceptin C1q Binding Assays

BioOutsource offers off-the-shelf Herceptin C1q binding assays to support Herceptin biosimilar manufacture, process development, characterization and comparability studies. We offer industry leading Herceptin comparability and Herceptin characterization services and these can be adapted to suit your product, if required.

The complement system complements the ability of antibodies to clear pathogens and cancerous cells from the body. It is a collection of small proteins present in the blood that typically circulate as inactive precursors. The classical pathway is triggered by activation of the C1-complex which is composed of a single C1q molecule with 2 molecules of C1r and C1s and occurs when C1q binds multiple IgG molecules complexed with antigen; this can lead to a signalling cascade culminating in complement-dependent cytotoxicity (CDC). Herceptin (trastuzumab) mediates its activity through the interaction with the Her2/neu protein and following binding, Herceptin is capable of activating the complement cascade, although no herceptin complement-mediated cell lysis is reported. Activation of complement is experimentally determined using the C1q binding assay.