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

页码：803 / 814

页数：12

共 50 条

[21] INTRAVITREAL INJECTION OF THERAPEUTIC AGENTS
Peyman, Gholam A.
Lad, Eleonora M.
Moshfeghi, Darius M.
RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2009, 29 (07): : 875 - 912
[22] Immunogenicity of therapeutic monoclonal antibodies
Pendley, C
Schantz, A
Wagner, C
CURRENT OPINION IN MOLECULAR THERAPEUTICS, 2003, 5 (02) : 172 - 179
[23] Elimination of the immunogenicity of therapeutic antibodies
Gilliland, LK
Walsh, LA
Frewin, MR
Wise, MP
Tone, M
Hale, G
Kioussis, D
Waldmann, H
JOURNAL OF IMMUNOLOGY, 1999, 162 (06): : 3663 - 3671
[24] A quantitative sonoelastography evaluation of ocular and periocular elasticity after intravitreal ranibizumab injection
Sayin, N.
Kocak, I.
Pehlivanoglu, S.
Pekel, G.
Er, A.
Bayramoglu, S. E.
Aydin, A.
JOURNAL FRANCAIS D OPHTALMOLOGIE, 2023, 46 (09): : 1030 - 1038
[25] Ocular Pharmacokinetics of Therapeutic Antibodies Given by Intravitreal Injection: Estimation of Retinal Permeabilities Using a 3-Compartment Semi-Mechanistic Model
Hutton-Smith, Laurence A.
Gaffney, Eamonn A.
Byrne, Helen M.
Maini, Philip K.
Gadkar, Kapil
Mazer, Norman A.
MOLECULAR PHARMACEUTICS, 2017, 14 (08) : 2690 - 2696
[26] OCULAR FINDINGS FOLLOWING INTRAVITREAL SILICONE INJECTION
LAROCHE, L
PAVLAKIS, C
SARAUX, H
ORCEL, L
ARCHIVES OF OPHTHALMOLOGY, 1983, 101 (09) : 1422 - 1425
[27] 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
[28] Decelerated neurodegeneration after intravitreal injection of α-synuclein antibodies in a glaucoma animal model
J. Teister
F. Anders
S. Beck
S. Funke
H. von Pein
V. Prokosch
N. Pfeiffer
F. Grus
Scientific Reports, 7
[29] Circumventing immunogenicity in the development of therapeutic antibodies
Holgate, Robert G. E.
Baker, Matthew P.
IDRUGS, 2009, 12 (04) : 233 - 237
[30] Trabecular microbypass stent to treat ocular hypertension after intravitreal injection of a dexamethasone implant
Guemes-Villahoz, N.
Garcia-Feijoo, J.
Martinez-de-la-Casa, J. M.
Torres-Imaz, R.
Donate-Lopez, J.
JOURNAL FRANCAIS D OPHTALMOLOGIE, 2021, 44 (10): : E591 - E594

← 1 2 3 4 5 →