Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection

被引：17
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
  • [31] Ocular Biodistribution of Spironolactone after a Single Intravitreal Injection of a Biodegradable Sustained-Release Polymer in Rats
    Dahmana, Naoual
    Kowalczuk, Laura
    Gabriel, Doris
    Behar-Cohen, Francine
    Gurny, Robert
    Kalia, Yogeshvar N.
    MOLECULAR PHARMACEUTICS, 2020, 17 (01) : 59 - 69
  • [32] Cross-reactive and pre-existing antibodies to therapeutic antibodies-Effects on treatment and immunogenicity
    van Schie, Karin A.
    Wolbink, Gerrit-Jan
    Rispens, Theo
    MABS, 2015, 7 (04) : 662 - 671
  • [33] Duration of Vascular Endothelial Growth Factor Suppression after Intravitreal Injection of Faricimab in Macaque Eyes
    Matsumoto, Riko
    Obata, Shumpei
    Kakinoki, Masashi
    Sawada, Osamu
    Kawamoto, Ikuo
    Murase, Mitsuru
    Ohji, Masahito
    JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS, 2025, 41 (01) : 33 - 38
  • [34] Quantification and Structure Elucidation of in Vivo Bevacizumab Modification in Rabbit Vitreous Humor after Intravitreal Injection
    Chu, Kai On
    Liu, David Ta Li
    Chan, Kwok Ping
    Yang, Ya Ping
    Yam, Gary Hin Fai
    Rogers, Michael S.
    Pang, Chi Pui
    MOLECULAR PHARMACEUTICS, 2012, 9 (12) : 3422 - 3433
  • [35] Short-term impact of intravitreal ranibizumab injection on axial ocular dimension and intraocular pressure
    Goktas, Altan
    Goktas, Sertan
    Atas, Mustafa
    Demircan, Suleyman
    Yurtsever, Yusufcan
    CUTANEOUS AND OCULAR TOXICOLOGY, 2013, 32 (01) : 23 - 26
  • [36] Short-term changes of intraocular pressure and ocular perfusion pressure after intravitreal injection of bevacizumab or ranibizumab
    Lee, Jong Wook
    Park, Hoon
    Choi, Jeong Han
    Lee, Hyun Joo
    Moon, Sang Woong
    Kang, Ja Heon
    Kim, Young Gyun
    BMC OPHTHALMOLOGY, 2016, 16
  • [37] Ocular pulse amplitude and retinal vessel caliber changes after intravitreal ranibizumab
    Pekel, Gokhan
    Acer, Semra
    Cetin, Ebru Nevin
    Yagci, Ramazan
    Kasikci, Alper
    Cevik, Ali
    INTERNATIONAL OPHTHALMOLOGY, 2015, 35 (05) : 657 - 662
  • [38] CLEARANCE AND DISTRIBUTION OF CIPROFLOXACIN AFTER INTRAVITREAL INJECTION
    PEARSON, PA
    HAINSWORTH, DP
    ASHTON, P
    RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 1993, 13 (04): : 326 - 330
  • [39] VOLUME AND COMPOSITION OF REFLUX AFTER INTRAVITREAL INJECTION
    Brodie, Frank L.
    Ruggiero, Jason
    Ghodasra, Devon H.
    Hui, James Z.
    Vanderbeek, Brian L.
    Brucker, Alexander J.
    RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2014, 34 (07): : 1473 - 1476
  • [40] ENDOPHTHALMITIS AFTER INTRAVITREAL INJECTION Role of Prophylactic Topical Ophthalmic Antibiotics
    Li, Alexa L.
    Wykoff, Charles C.
    Wang, Rui
    Chen, Eric
    Benz, Matthew S.
    Fish, Richard H.
    Wong, Tien P.
    Major, James C., Jr.
    Brown, David M.
    Schefler, Amy C.
    Kim, Rosa Y.
    O'Malley, Ronan E.
    RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2016, 36 (07): : 1349 - 1356
12345