Literature DB >> 29637799

Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection.

Uwe Wessels1, Markus Zadak1, Astrid Reiser1, Janis Brockhaus2, Mirko Ritter2, Afsaneh Abdolzade-Bavil1, Julia Heinrich1, Kay Stubenrauch1.   

Abstract

AIM: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drug-sensitive immunoassays. A drug-tolerant immunoassay is therefore desirable for immunogenicity testing in ophthalmology. EXPERIMENTAL: Immune complex (IC) antidrug antibody (ADA) assays were established for two species. The assays were compared with the bridging assay in ocular and plasma samples from two preclinical studies.
RESULTS: The IC assays showed high drug tolerance, which enabled a reliable ADA detection in ocular fluids after intravitreal administration. The IC assays were superior to the bridging assay in the analysis of ocular fluids with high drug concentrations.
CONCLUSION: The IC assay allows a reliable ADA detection in matrices with high drug concentrations, such as ocular fluids.

Entities:  

Keywords:  ELISA; antidrug antibody; aqueous humor; drug tolerance; immune complex assay; immunogenicity; ophthalmology; safety assessment; vitreous humor

Mesh:

Substances:

Year:  2018        PMID: 29637799     DOI: 10.4155/bio-2018-0047

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  3 in total

1.  Biotherapeutics and immunogenicity: ophthalmic perspective.

Authors:  Ashish Sharma; Nilesh Kumar; Baruch D Kuppermann; Francesco Bandello; Anat Loewenstein
Journal:  Eye (Lond)       Date:  2019-04-09       Impact factor: 3.775

2.  Subcutaneous Site-of-Absorption Study with the Monoclonal Antibody Tocilizumab in Minipigs: Administration Behind Ear Translates Best to Humans.

Authors:  Wolfgang F Richter; Hans-Peter Grimm; Marie-Hélène Gouy; Susi Søgaard; Caroline Kreuzer; Uwe Wessels; Dragomir Draganov; Chris Muenzer; Tonio Hoche
Journal:  AAPS J       Date:  2020-04-03       Impact factor: 4.009

Review 3.  Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.

Authors:  Tong-Yuan Yang; Manuela Braun; Wibke Lembke; Fraser McBlane; John Kamerud; Stephen DeWall; Edit Tarcsa; Xiaodong Fang; Lena Hofer; Uma Kavita; Vijay V Upreti; Swati Gupta; LiNa Loo; Alison J Johnson; Rakesh Kantilal Chandode; Kay-Gunnar Stubenrauch; Maya Vinzing; Cindy Q Xia; Vibha Jawa
Journal:  Mol Ther Methods Clin Dev       Date:  2022-08-02       Impact factor: 5.849

  3 in total

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