Anti-ravulizumab antibodies are neutralizing or binding antibodies generated in response to treatment with ravulizumab, a humanized monoclonal IgG2/4 kappa antibody that targets complement component 5 (C5). As a terminal complement inhibitor, ravulizumab functions by preventing C5 cleavage into C5a and C5b, thereby blocking the formation of the membrane attack complex (C5b-9). This pathway is critical in the management of rare blood disorders like paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and certain cases of myasthenia gravis.
In clinical settings, the presence of anti-ravulizumab antibodies (ADAs) may indicate immunogenicity, which can interfere with the efficacy and safety of treatment. These antibodies can either neutralize the biologic activity of ravulizumab by blocking its binding to C5 or alter its pharmacokinetics, potentially reducing serum drug levels and therapeutic effect. Monitoring for anti-drug antibodies is an essential component of therapeutic drug monitoring (TDM) to optimize dosage regimens and patient outcomes.
In research, anti-ravulizumab antibodies serve as valuable biomarkers for assessing immune responses to biologic therapy. They can help elucidate mechanisms of drug resistance, treatment failure, or unexpected side effects in patient populations. Furthermore, studying these biomarkers across diverse cohorts supports the development of biosimilars and next-generation C5 inhibitors with reduced immunogenicity and enhanced clinical performance.
This product is manufactured in Turkey by Matriks Biotek.