nab sample test
A neutralizing antibody (NAb) is an antibody that defends a cell from an antigen or infectious body by neutralizing any effect it has biologically. NAbs against therapeutic proteins or peptides can significantly decrease the efficacy of these drug candidates, which is why NAb test serves as a crucial aspect in immunogenicity test. Generally, FDA considers that bioassays are more reflective of the in vivo situation and are recommended. For NAb assays, the bioassay should be related to mechanism of action, otherwise the assays will not be informative enough as to the effect of NAbs on clinical results. The development and validation of neutralization assays are difficult and vary dramatically between different samples. Nonetheless, cell based assays are still recommended because they are critical to understanding the importance of patient immune responses to therapeutic proteins.
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