Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates

Stubenrauch, Kay; Wessels, Uwe; Lenz, Helmut

doi:10.1016/j.jpba.2009.01.030

Cited by 37 publications

(21 citation statements)

References 11 publications

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“…Relative IgG1 expression ELISA. IgG1 expression in cell culture supernatants was determined by sandwich ELISA using a mouse anti-human IgG (clone R10Z8E9) 76 capture antibody and the same antibody as biotin conjugate for detection with streptavidin-AP and AttoPhos (Roche). Relative IgG1 expression levels were calculated by dividing the signal of the respective VH/VL pair through the signal of the reference IgG1 antibody MOR03080.…”

Section: Methodsmentioning

confidence: 99%

A fully synthetic human Fab antibody library based on fixed VH/VL framework pairings with favorable biophysical properties

Tiller

Schuster

Deppe

et al. 2013

mAbs

176

147

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Section: Methodsmentioning

confidence: 99%

A fully synthetic human Fab antibody library based on fixed VH/VL framework pairings with favorable biophysical properties

Tiller

Schuster

Deppe

et al. 2013

mAbs

176

147

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“…Total mAb concentrations were measured with a generic enzyme-linked immunosorbent assay (ELISA) (18). The assay was performed in streptavidincoated 96 well microplates using biotinylated and digoxigenylated mouse monoclonal anti-human Fcγ antibodies as capture and detection reagents.…”

Section: Methodsmentioning

confidence: 99%

Neonatal Immune Tolerance Induction to Allow Long-Term Studies With an Immunogenic Therapeutic Monoclonal Antibody in Mice

Piccand

Bessa

Schick

et al. 2015

AAPS J

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Abstract. The purpose of this study is to test the feasibility of neonatal immune tolerance induction in mice to enable long-term pharmacokinetic studies with immunogenic therapeutic monoclonal antibodies (mAb). Neonatal immune tolerance was induced by transfer of a mAb to neonatal mice via colostrum from nursing mother mice treated with two subcutaneous doses of a tolerogen starting within the first 24 h after delivery. Adalimumab and efalizumab were administered as tolerogens at various dose levels. Tolerance induction was evaluated in the offspring after reaching adulthood at 8 weeks of age. After a single intravenous injection of the same mAb as used for tolerance induction, the pharmacokinetics of the mAb and formation of anti-drug antibodies (ADA) in plasma were assessed using ELISA. Tolerance induction to adalimumab was achieved in a maternal dose-dependent manner. Adalimumab immunetolerant offspring showed a slower adalimumab clearance (4.24±0.32 mL/day/kg) as compared to the control group (12.09±3.81 mL/day/kg). In the control group, accelerated clearance started 7 days after adalimumab dosing, whereas immune-tolerant offspring showed a log-linear terminal concentration-time course. In the offspring, the absence of predose ADA levels was indicative of successful tolerance induction. The second test compound efalizumab was not immunogenic in mice under our experimental conditions. Overall, the present study demonstrated the suitability of neonatal immune tolerance induction for a 4-week single dose study in adult mice with a human therapeutic mAb that is otherwise immunogenic in laboratory animals.

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“…2. The use of an antibody specific for human IgG is also generic and applicable to animal but not to human samples [15,24]. As these approaches demand enormous binding capacities, they appear rather limited for efficient removal of anti-A2V.…”

Section: Efficiency Of Anti-id-anti-vegf Mab Capturing In Comparison mentioning

confidence: 99%

An immunodepletion procedure advances free angiopoietin-2 determination in human plasma samples during anti-cancer therapy with bispecific anti-Ang2/VEGF CrossMab

Stubenrauch¹,

Wessels²,

Essig³

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates

Cited by 37 publications

References 11 publications

A fully synthetic human Fab antibody library based on fixed VH/VL framework pairings with favorable biophysical properties

A fully synthetic human Fab antibody library based on fixed VH/VL framework pairings with favorable biophysical properties

Neonatal Immune Tolerance Induction to Allow Long-Term Studies With an Immunogenic Therapeutic Monoclonal Antibody in Mice

An immunodepletion procedure advances free angiopoietin-2 determination in human plasma samples during anti-cancer therapy with bispecific anti-Ang2/VEGF CrossMab

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