Eliminating drug target interference with specific antibody or its F(ab')2 fragment in the bridging immunogenicity assay

Background: DB-1003 is a humanized anti-IgE monoclonal antibody with higher affinity than omalizumab. In the affinity capture elution (ACE)-based bridging electrochemiluminescent immunoassay (ECLIA) for antibodies to DB-1003, monkey serum IgE caused false-positive results. Materials & methods: The target-specific antibody or its F(ab')2 fragment was used to mitigate drug target interference in an ACE-based bridging ECLIA for the detection of anti-DB-1003 antibodies. Results: The sensitivity of the developed assay was at least 100 ng/ml. When the anti-drug antibody concentration was 250 ng/ml, the assay tolerated at least 20.0 μg/ml of the monkey IgE. Conclusion: Incorporating the target-specific antibody or its F(ab')2 fragment can overcome the interference from monkey serum IgE in ACE-based bridging ECLIA for anti-DB-1003 antibody detection.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:16

Enthalten in:

Bioanalysis - 16(2024), 7 vom: 26. März, Seite 135-148

Sprache:

Englisch

Beteiligte Personen:

Deng, Xiaojie [VerfasserIn]
Hou, Yingying [VerfasserIn]
Yuan, Wenyi [VerfasserIn]
Yang, Hongzhou [VerfasserIn]
Guo, Ruowen [VerfasserIn]
Liu, Tingting [VerfasserIn]
Liu, Yongzhen [VerfasserIn]
Xu, Junjiu [VerfasserIn]
Liu, Heng [VerfasserIn]
Gong, Likun [VerfasserIn]
Qin, Qiuping [VerfasserIn]

Links:

Volltext

Themen:

37341-29-0
Anti-drug antibody
Antibodies, Monoclonal
IgE
Immunogenicity
Immunoglobulin E
Immunoglobulin Fab Fragments
Journal Article
Mitigation
Target interference

Anmerkungen:

Date Completed 26.03.2024

Date Revised 26.03.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.4155/bio-2023-0191

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM368759113