Meso Scale ADA assay has a range of ADA assay development materials for developing and implementing confirmatory ADA assay, NAb neutralizing antibody assay, and drug tolerance ADA assay. The Meso Scale platform is based on electrochemiluminescence detection and multi-array technology. The combination of such robust features provides higher sensitivity, a broader dynamic range, and a flexible ADA antibody assay.
MSD assay has numerous options, such as PK ADA biomarker, NAb assay, and ADA ELISA assay. Besides, the MSD ADA method can assess multiple analytes, including peptides, proteins, and antibodies. MSD ADA assays employ a simple protocol involving a homogenous solution phase incubation. On the other hand, the direct ADA assay format offers a streamlined assay protocol with a reduced number of washing steps.
Meso Scale ADA assay is a robust bioanalytical test for assessing drug immunogenicity. Hence, the current article discusses the role of ADA CROs such as NorthEast Biolab in Meso Scale ADA antibody assay.
Meso Scale ADA antibody assay
The Meso scale ADA bridging assay has only a single wash step enabling the detection of low-affinity ADAs. MSD immunogenicity assay development is rapid and exhibits better drug tolerance compared to other traditional formats. Notably, this ADA method is independent of species as it does not need species-specific reagents. Therefore, ADA CROs can employ the same Meso Scale ADA bridging assay format for preclinical and clinical studies.
Robust Meso Scale ADA bringing assays require specific preliminary experiments to optimize the assay format. The biotinylated drug concentration, Sulfo-tag labels, and the minimum required sample dilution are the three primary parameters for optimizing bridging immunogenicity assays. The following section describes the four preliminary experiments to optimize Meso Scale ADA bridging assays.
Testing sensitivity and optimizing reagent concentrations
This experiment comprises two parts. The first section involves testing assay sensitivity. It includes using a master mix solution with equal concentrations of Sulfo-tag labeled and biotinylated drugs. In this particular experiment, researchers test three or more different concentrations of Sulfo-tag labeled and biotinylated drugs in a titration series of ADAs. The next section of the investigation deals with optimizing the concentrations of sulfo-tag-labeled and biotin-labeled drugs through a checkerboard approach.
The second experiment tests matrix tolerance. Once the optimal concentrations of Sulfo-tag labeled and biotinylated drug products are determined, researchers assess the matrix tolerance of the Meso Scale ADA bridging assay.
The third experiment is the test for free drug tolerance. MSD assays are more drug-tolerant. This tolerance can lead to suppressed signals and false negatives. Hence, bioanalytical labs use a homogenous solution incubation step to reduce the effects of drug interference.
The final preliminary experiment is improving drug tolerance through assay-induced dissociation. Researchers employ assay-induced dissociation to enhance drug tolerance of ADA bridging assay. This protocol focuses on treating the study sample with an assay to dissociate the ADA drug complex and neutralize it through an excess of biotinylated and sulfo-tag-labeled drugs.
Besides, ADA CROs such as NorthEast Biolab have specific strategies to enhance MSD assay performances and ADA validation initiatives. They improve drug tolerance by extending the incubation period of the Sulfo-tag and biotinylated labeled drug and the study sample to overnight incubation. Moreover, drug interference can be reduced by increasing the level of Sulfo-tag and biotinylated labeled drugs.