Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control

Aim: To develop an assay format for detection of total anti-adeno-associated virus 2 (AAV2) antibodies with low capsid material consumption. Methods: An immune complex (IC) assay format was developed. The format is based on the formation of ICs in solution and their subsequent detection using an anti-AAV2 antibody for capture and an antibody against the study species IgG for detection. Results: The feasibility of the IC assay for detection of preexisting and treatment-emergent anti-AAV2 antibodies was demonstrated in cynomolgus monkey and human serum samples, including samples from a preclinical study with AAV2-based therapies. Conclusion: The presented IC assay is an easy-to-perform total anti-AAV2 antibody assay that requires a small amount of unlabeled capsid material and provides an intrinsic specificity control.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - year:2024

Enthalten in:

Bioanalysis - (2024) vom: 18. März

Sprache:

Englisch

Beteiligte Personen:

Wessels, Uwe [VerfasserIn]
Neff, Florian [VerfasserIn]
Fakhiri, Julia [VerfasserIn]
Mayer, Klaus [VerfasserIn]
Brinkmann, Ulrich [VerfasserIn]
Stubenrauch, Kay [VerfasserIn]

Links:

Volltext

Themen:

Gene therapy
Immune complex assay
Immunogenicity
Journal Article
Review
Total anti-AAV antibody assay

Anmerkungen:

Date Revised 18.03.2024

published: Print-Electronic

Citation Status Publisher

doi:

10.4155/bio-2023-0254

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM369874625