2023年9月22日 · Despite the challenges posed by the interference, we successfully developed a robust CD47 ECL cell-based binding assay capable of detecting 1 µg/mL of a NAb PC in the presence of clinically relevant drug concentrations up to 400 µg/mL.

2021年11月11日 · Presented here is the development and validation of a competitive ligand-binding assay that specifically detects anti-dostarlimab NAbs in human serum. Precision, sensitivity, hook effect, selectivity, assay robustness, …

2021年10月13日 · 常规用于抗体类药物中和抗体分析的试验模式( format)分别为: 基于细胞的生物学试验( cell based assay) 、非细胞的竞争性配体结合试验(non-cell competitive ligand-binding assay，CLBA) 。

2018年1月1日 · In this report, we describe development and validation of a cell-based assay for detection of neutralizing antibodies (Nab) against insulin and insulin analogues. In order to achieve clinically meaningful sensitivity the method used an early signalling event, insulin induced insulin receptor phosphorylation as the endpoint.

NAb assays are qualitative assays • A well-designed NAb assay should be able to detect clinically relevant NAbs • Efforts are ongoing in industry to compile recommendations for consistent use of cell - based and non cell-based NAb assays • Bioanalytical approaches for “Trigger” -based NAb assay availability need discussion 13

2023年6月1日 · Acid treatment methods like Dynabeads extraction and affinity capture elution can help improve drug tolerance in NAb assays. Neutralizing anti-drug antibodies (ADAs) may affect safety, efficacy, and pharmacokinetic profile of a biotherapeutic drug and thus their assessment is of particular importance during immunogenicity testing.

2017年12月28日 · NAb assays are based on the ability of ADA to neutralize a drugs’ biological function. Therefore, it is critical to find an optimal drug concentration in the assay system which allows for sufficient bioactivity signal and the concentration selected allows optimum neutralizing effect by the APC.

2023年9月22日 · To support clinical development of PF-07257876, neutralizing antibody (NAb) assays were developed as part of a tiered immunogenicity testing approach. Because PF-07257876 targets both CD47 and PD-L1, determination of domain specificity of a NAb response may provide additional insight relating to PK, efficacy, and safety.

2019年3月29日 · An ECL assay on the MSD® platform was used to assess NAb response against anti-TFPI mAb. Samples in sodium citrate plasma were diluted 1:2 with assay buffer, then further diluted 1:6 with ruthenium-drug conjugate (21.2 ng/mL in assay buffer).

In this report, a cell-based assay was developed using luciferase reporter-gene bioassays and validated for the detection of NAb activity which was produced by rhesus monkeys after injection of Aflibercept. Twelve serum samples of rhesus monkeys with positive ADA were tested for NAb by the cell-based bioassay.