Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection

被引：18
|
作者：
Wessels, Uwe [1 ]
Zadak, Markus [1 ]
Reiser, Astrid [1 ]
Brockhaus, Janis [2 ]
Ritter, Mirko [2 ]
Abdolzade-Bavil, Afsaneh [1 ]
Heinrich, Julia [1 ]
Stubenrauch, Kay [1 ]
机构：
[1] Roche Innovat Ctr Munich, Pharma Res & Early Dev, Pharmaceut Sci, Nonnenwald 2, D-82377 Penzberg, Germany
[2] Roche Diagnost GmbH, Roche Innovat Ctr Munich, Nonnenwald 2, D-82377 Penzberg, Germany
来源：
BIOANALYSIS | 2018年 / 10卷 / 11期
关键词：
antidrug antibody; aqueous humor; drug tolerance; ELISA; immune complex assay; immunogenicity; ophthalmology; safety assessment; vitreous humor; DRUG TOLERANCE; BIOTECHNOLOGY PRODUCTS; MACULAR DEGENERATION; TARGET INTERFERENCE; VITREOUS-HUMOR; SERUM SAMPLES; ASSAYS; RECOMMENDATIONS; PHARMACOKINETICS; RANIBIZUMAB;
D O I：
10.4155/bio-2018-0047
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
Aim: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drugsensitive 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.
引用
收藏
页码：803 / 814
页数：12
相关论文
共 50 条
  • [11] Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework
    Williams, Jason H.
    Liao, Kai H.
    Yin, Donghua
    Meng, Xu
    AAPS JOURNAL, 2024, 26 (02)
  • [12] Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet® biolayer interferometry
    Li, Jian
    Schantz, Allen
    Schwegler, Maureen
    Shankar, Gopi
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2011, 54 (02) : 286 - 294
  • [13] Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework
    Jason H. Williams
    Kai H. Liao
    Donghua Yin
    Xu Meng
    The AAPS Journal, 26
  • [14] Immunogenicity of therapeutic monoclonal antibodies
    Pendley, C
    Schantz, A
    Wagner, C
    CURRENT OPINION IN MOLECULAR THERAPEUTICS, 2003, 5 (02) : 172 - 179
  • [15] Computer modeling of bevacizumab drug distribution after intravitreal injection in rabbit and human eyes
    Chowdhury, Jabia M.
    Ruiz, Eduardo A. Chacin
    Ohr, Matthew P.
    Swindle-Reilly, Katelyn E.
    Versypt, Ashlee N. Ford
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2025, 114 (02) : 1164 - 1174
  • [16] Circumventing immunogenicity in the development of therapeutic antibodies
    Holgate, Robert G. E.
    Baker, Matthew P.
    IDRUGS, 2009, 12 (04) : 233 - 237
  • [17] Are Ocular and Serum Half-Lives After Ranibizumab Intravitreal Injection Dependent on Dose?
    van Donge, Tamara
    Brizzi, Francesco
    Caruso, Antonello
    Fueth, Matthias
    Steiert, Bernhard
    TRANSLATIONAL VISION SCIENCE & TECHNOLOGY, 2023, 12 (04):
  • [18] Decelerated neurodegeneration after intravitreal injection of α-synuclein antibodies in a glaucoma animal model
    Teister, J.
    Anders, F.
    Beck, S.
    Funke, S.
    von Pein, H.
    Prokosch, V.
    Pfeiffer, N.
    Grus, F.
    SCIENTIFIC REPORTS, 2017, 7
  • [19] TOXIC VITREITIS OUTBREAK AFTER INTRAVITREAL INJECTION
    Ness, Thomas
    Feltgen, Niklas
    Agostini, Hansjuergen
    Boehringer, Daniel
    Lubrich, Beate
    RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2010, 30 (02): : 332 - 338
  • [20] Rhegmatogenous Retinal Detachment after Intravitreal Injection
    Brown, Karen R.
    Yannuzzi, Nicolas A.
    Smiddy, William E.
    Gregori, Ninel Z.
    Berrocal, Audina M.
    Haddock, Luis J.
    Schwartz, Stephen G.
    Lee, Wen-Hsiang
    Sridhar, Jayanth
    Wu, David M.
    Flynn, Harry W., Jr.
    Townsend, Justin H.
    OPHTHALMOLOGY RETINA, 2021, 5 (02): : 178 - 183
12345