Humira C1q Binding Assays
BioOutsource offers off-the-shelf Humira C1q binding assays to support Humira biosimilar manufacture, process development, characterization and comparability studies. We offer industry leading Humira comparability and Humira characterization services and can be adapted to function as qualified or validated cGMP lot release and stability studies for your product.
The complement system compliments 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 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). Humira (adalimumab) mediates its activity through the interaction with the TNF-Alpha and following binding to the membrane bound form, Humira is capable of activating the complement cascade and inducing cell lysis via complement dependent cytotoxicity. Activation of complement is experimental determined using the C1q binding assay.