Nab sample test

Neutralizing Antibody (NAb) Test Service

INQUIRY

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.

Cell-based NAb assay designs utilize intracellular signaling events

triggered by the drug candidates or the ligand inhibited by the drug

candidates, and may also utilize study of extracellular binding

events at the cell surface. The frequently-used readouts for

Profacgen’s NAb cell based assays include: cell proliferation,

biomarker, reporter gene expression, antibody- dependent

cell-mediated cytotoxicity (ADCC), etc.

The followings are provided by Profacgen for conducting a

cell-based NAb assay for a given sample:

Neutralizing Antibody (NAb) Test Service

Stable cell line responsive to drug

Measurable readout

Robust signal to noise ratio in serum matrix

Availability of a positive control

Medium to high throughput

Adaptability to automation

Because of limitations for cell based assays (suitable cell line,

interference, specificity, sensitivity, etc.), once neutralizing

cell-based assays are not feasible for your sample, Profacgen can

also provide competitive ligand binding assays or alternative assay

methods. All these methods been verified for their reflection of

neutralizing capacity/potential.

Please feel free to contact us if you are interested in or have any

questions for our NAb test service.