Development of a novel homogenous electrochemiluminescence assay for quantitation of ranibizumab in human serum

Lowe, John R.; Maia, Maurício; Wakshull, Eric; Siguenza, Patricia; Liu, Patrick; Lakhani, Saleem; Rusit, Jeriza; Elliott, Rebecca; Quarmby, Valerie

doi:10.1016/j.jpba.2010.01.048

Cited by 12 publications

(7 citation statements)

References 25 publications

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“…The total concentration of ranibizumab in serum was determined by an electrochemiluminescent assay. 23 Briefly, ranibizumab molecules were captured by biotinylated recombinant humanized VEGF-A bound to streptavidin-coated paramagnetic beads. A ruthenium-base tag (ORIÀTAG) conjugated rabbit antiÀrhuFab V2 antibody was used for detection.…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration: A Population Approach

Xu¹,

Tong²,

Tuomi³

et al. 2013

Invest. Ophthalmol. Vis. Sci.

178

158

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PURPOSE. To characterize ranibizumab pharmacokinetics in patients with AMD. METHODS.A population approach of nonlinear mixed-effect pharmacokinetic modeling based on concentration-time data from 2993 serum samples from 674 AMD patients enrolled in 5 phase 1 to 3 clinical trials of single or multiple intravitreal (ITV) doses of ranibizumab (0.3-2.0 mg/eye) administered biweekly or monthly for up to 24 months. RESULTS.A total of 696 concentration-time records from 229 subjects with one or more measurable total serum ranibizumab concentrations were analyzed. The systemic concentration-time data for ranibizumab were best described by a one-compartment model with first-order absorption into and first-order elimination from the systemic circulation. Vitreous elimination half-life (t 1/2 ) was calculated to be 9 days and the intrinsic systemic elimination t 1/2 was calculated to be approximately 2 hours. Following ITV administration, ranibizumab egresses slowly into the systemic circulation, resulting in an apparent serum t 1/2 of 9 days. Systemic-to-vitreous exposure ratio was estimated to be 1:90,000. With monthly and quarterly ITV regimens, the serum concentrations of ranibizumab at steadystate for both the 0.3 and 0.5 mg/eye dose levels were estimated to be below the range needed to inhibit VEGF-A-induced endothelial cell proliferation in vitro by 50% at all times.CONCLUSIONS. Systemic exposure to ranibizumab after ITV injection was very low due to elimination on reaching systemic circulation from the vitreous. Population pharmacokinetic analysis of data from a representative sample of AMD patients did not identify clinically significant sources or correlates of variability in ranibizumab exposure. (ClinicalTrials.gov numbers, NCT00056836, NCT00056823.) (Invest Ophthalmol Vis

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Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration: A Population Approach

Xu¹,

Tong²,

Tuomi³

et al. 2013

Invest. Ophthalmol. Vis. Sci.

178

158

View full text Add to dashboard Cite

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“…Lowe et al developed a novel electrochemiluminescence assay (ECLA) that allowed for a more sensitive determination of ranibizumab in serum. This assay was first used to support some clinical trials, offering 67 times more sensitivity than a conventional ELISA (20 ng/mL) [81] and with a reporting range of 0.3–24 ng/mL [82]. More recently, the same authors have presented another novel method that utilises a high-affinity monoclonal anti-ranibizumab-VEGF-complexes antibody (MARA) to measure ranibizumab in human serum.…”

Section: Pharmacokinetic Considerationsmentioning

confidence: 99%

Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration

et al. 2019

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Intravitreal administration of anti-vascular endothelial growth factor (VEGF) antibodies has become the standard treatment for Age-Related Macular Degeneration; however, the knowledge of their pharmacokinetics is limited. A comprehensive review of the preclinical and clinical pharmacokinetic data that were obtained in different studies with intravitreal bevacizumab, ranibizumab, and aflibercept has been conducted. Moreover, the factors that can influence the vitreous pharmacokinetics of these drugs, as well as the methods that were used in the studies for analytical determination, have been exposed. These anti-VEGF drugs present different charge and molecular weights, which play an important role in vitreous distribution and elimination. The pharmacokinetic parameters that were collected differ depending on the species that were involved in the studies and on physiological and pathological conditions, such as vitrectomy and lensectomy. Knowledge of the intravitreal pharmacokinetics of the anti-VEGF drugs that were used in clinical practice is of vital importance.

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“… Drugs/Analytes Systems Linear ranges LOD (S/N = 3) Samples Ref. Ranibizumab Sandwich-type, biotinylated rhVEGF/antigen/ruthenium-labeled antibodies, captured by streptavidin-coated paramagnetic beads 300–24,000 pg/mL 300 pg/mL Human serum [56] Clenbuterol (CLB) CLB-BSA-CHIT-AuNPs/GCE, Competitive immunoassay, Ru(bpy) 3 2+ -labeled antibody 0.010–1.0 ng/mL 0.0050 ng/mL Swine urine [57] Thyroid stimulating hormone (TSH) Sandwich-type, enhancing ECL of S 2 O 8 2- -O 2 system 0.05–20 μIU/mL 0.02 μIU/mL Human serum [58] Morphine Signal-off, label-free, Ab/AuNPs/APTMS/ITO in PBS (pH 8.0)-0.1 mM H 2 O 2 2–200 ng/mL 0.82 ng/mL Spiked urine [59] Morphine Signal-off, label-free, Ab/CdS-PAMAM/AuNPs/Au in 0.1 M PBS-0.1 M K 2 S 2 O 8 (pH7.4) 0.2–180 ng/mL 67 pg/mL Human blood plasma [60] Phenylethanolamine A (PA) Competitive immunoassay, signal-off, PA-Ag/CHIT/CdSe QDs/GCE, PA-Ab/GaR IgG-HRP in 0.1 M Tris–HCl buffer (pH 9.0)-0.1 M KNO 3 -0.5 mM HQ 0.05–1000 ng/mL 0.015 ng/mL Pork and liver from swine [61] Brombuterol (Bro) Competitive immunoassay, signal-off, Bro-Ag/SWCNTs-PAMAM-Ag@Au/GCE, signal probe (PAMAM-Au-CdSe QDs) in 0.1 M PBS (pH 9.0)-0.1 M K 2 S 2 O 8 0.001–1000 ng/mL 37 fg/mL Pork and feed [62] Ketamine Signal-off, Ab/PAMAM-carbon dots/AuNPs/GCE) in 0.1 M PBS (pH 7.4)- 0.1 M K 2 S 2 O 8 0.2–200 ng/mL 0.067 ng/mL Spiked human plasma [63] Insulin Sandwich-type, ZnCd ...…”

Section: Ecl Immunoassays/immunosensorsmentioning

confidence: 99%

“…Lowe et al [56] developed a novel ECL immunoassay for quantitation of ranibizumab in human serum. In this assay, ruthenium (II) complex-labeled affinity-purified rabbit anti-ranibizumab antibodies and biotinylated rhVEGF are added to serum samples.…”

Section: Ecl Immunoassays/immunosensorsmentioning

confidence: 99%

Recent advances in electrogenerated chemiluminescence biosensing methods for pharmaceuticals

Zhang

Yang

et al. 2019

Journal of Pharmaceutical Analysis

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Electrogenerated chemiluminescence (electrochemiluminescence, ECL) generates species at electrode surfaces, which undergoes electron-transfer reactions and forms excited states to emit light. It has become a very powerful analytical technique and has been widely used in such as clinical testing, biowarfare agent detection, and pharmaceutical analysis. This review focuses on the current trends of molecular recognition-based biosensing methods for pharmaceutical analysis since 2010. It introduces a background of ECL and presents the recent ECL developments in ECL immunoassay (ECLIA), immunosensors, enzyme-based biosensors, aptamer-based biosensors, and molecularly imprinted polymers (MIP)-based sensors. At last, the future perspective for these analytical methods is briefly discussed.

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Development of a novel homogenous electrochemiluminescence assay for quantitation of ranibizumab in human serum

Cited by 12 publications

References 25 publications

Pharmacokinetics of Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration: A Population Approach

Pharmacokinetics of Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration: A Population Approach

Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration

Recent advances in electrogenerated chemiluminescence biosensing methods for pharmaceuticals

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