Quantification of active infliximab in human serum with liquid chromatography–tandem mass spectrometry using a tumor necrosis factor alpha -based pre-analytical sample purification and a stable isotopic labeled infliximab bio-similar as internal standard: A target-based, sensitive and cost-effective method

Amrani, Mohsin El; Broek, Marcel P. H. van den; Göbel, Camiel; Maarseveen, Erik M. van

doi:10.1016/j.chroma.2016.05.070

Cited by 39 publications

(18 citation statements)

References 25 publications

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“…Since a few years, research groups and companies have started quantifying biopharmaceuticals and ADA in blood samples. Different methods have been developed: fluid-phase radioimmunoassay, solid-phase enzyme-linked immunosorbent assay (ELISA), reporter gene assay, enzyme immunoassay, homogenous mobility shift assay and liquid chromatography–tandem mass spectrometry 53,54,59,60. The most common format for quantifying biopharmaceuticals is ELISA, in which the biopharmaceutical is captured on a plate and detected using a secondary antibody 59.…”

Section: How To Perform Tdm Of Biopharmaceuticals?mentioning

confidence: 99%

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases

Dreesen¹,

Bossuyt²,

Mulleman³

et al. 2017

CPAA

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Biopharmaceuticals directed against tumor necrosis factor-alpha, integrins, interleukins, interferons and their receptors have become key agents for the management of inflammatory diseases in the fields of gastroenterology, rheumatology, dermatology and neurology. However, response to these treatments is far from optimal. Therapeutic failure has been attributed in part to inadequate serum concentrations of the drug and the formation of antidrug antibodies (ADA). Therapeutic drug monitoring (TDM) based on drug concentrations and ADA represents a pharmacologically sound tool for guiding dosage adjustments to optimize exposure. Although becoming standard practice in tertiary care centers, the widespread accessibility and recognition of TDM is hindered by several hurdles, including a lack of education of health care providers on TDM. In this paper, the Monitoring of monoclonal Antibodies Group in Europe (MAGE) provides an introduction on the fundamental principles of the concept of TDM, aiming to educate clinicians and assist them in the process of implementing TDM of anti-inflammatory biopharmaceuticals.

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Section: How To Perform Tdm Of Biopharmaceuticals?mentioning

confidence: 99%

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases

Dreesen¹,

Bossuyt²,

Mulleman³

et al. 2017

CPAA

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“…A novel sample preparation method was developed based an optimized combination of established methods from literature [20, 24–27]. AS purification was found to be a fast, easy, and efficient way to remove plasma albumin which comprises of approximately 60% of total plasma proteins.…”

Section: Resultsmentioning

confidence: 99%

“…Recently, the introduction of highly sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) technology has enabled monoclonal antibody quantification. LC-MS/MS possesses notable advantages over ELISA methods such as faster assay setup times, wider linear dynamic rage, and most importantly higher selectivity [20, 21]. Therefore, we have developed an easy method to quantify total DNX in plasma using a novel sample preparation in combination with tandem mass spectrometry analysis.…”

Section: Introductionmentioning

confidence: 99%

Quantification of total dinutuximab concentrations in neuroblastoma patients with liquid chromatography tandem mass spectrometry

et al. 2018

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Neuroblastoma is one of the most commonly found solid tumors in children. The monoclonal antibody dinutuximab (DNX) targets the sialic acid-containing glycosphingolipid GD2 expressed on almost all neuroblastoma tumor cells and induces cell lysis. However, the expression of GD2 is not limited to tumor cells only, but is also present on central nerve tissue and peripheral nerve cells explaining dinutuximab toxicity. The most common adverse reactions are pain and discomfort, which may lead to discontinuation of the treatment. Furthermore, there is little to no data available on exposure and effect relationships of dinutuximab. We, therefore, developed an easy method in order to quantify dinutuximab levels in human plasma. Ammonium sulfate (AS) was used to precipitate all immunoglobulins (IgGs) in human plasma. After centrifugation, supernatant containing albumin was decanted and the precipitated IgG fraction was re-dissolved in a buffer containing 0.5% sodium dodecyl sulfate (SDS). Samples were then reduced, alkylated, and digested with trypsin. Finally, a signature peptide in complementarity determining region 1 of DNX heavy chain was quantified on LC-MS/MS using a stable isotopically labeled peptide as internal standard. AS purification efficiently removed 97.5% of the albumin fraction in the supernatant layer. The validation performed on DNX showed that within-run and between-run coefficients of variation (CV) for lower limit of quantification (LLOQ) were 5.5 and 1.4%, respectively. The overall CVs for quality control (QC) low, QC med, and QC high levels were < 5%. Linearity in the range 1–32 mg/L was excellent (r2 > 0.999). Selectivity, stability, and matrix effect were in concordance with EMA guidelines. In conclusion, a method to quantify DNX in human plasma was successfully developed. In addition, the high and robust process efficiency enabled the utilization of a stable isotopically labeled (SIL) peptide instead of SIL DNX, which was commercially unavailable. Graphical abstract

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“…We and other independent teams recently developed and validated liquid chromatography/tandem mass spectrometry (LC–MS/MS) methods for the quantification of IFX in human serum. These methods are highly specific and reproducible, but require the determination of new clinically relevant IFX threshold, as recommended whenever a new analytical method is used for the measure of a biotherapy concentration .…”

Section: Introductionmentioning

confidence: 99%

New steps in infliximab therapeutic drug monitoring in patients with inflammatory bowel diseases

Némoz

Ternant

Bailly

et al. 2019

Brit J Clinical Pharma

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AIMSTherapeutic drug monitoring (TDM) of infliximab (IFX) appears to be beneficial for patients with inflammatory bowel disease (IBD). However, the recommended target concentrations depend partly on the method used to quantify IFX. Since we recently developed a liquid chromatography-tandem mass spectrometry method to quantify IFX, we aimed to determine IFX trough concentrations (Cmin) associated with biological remission. METHODSWe retrospectively measured IFX Cmin in sera from 55 patients with IBD, on IFX maintenance therapy, and for whom demographic, biological and clinical data were collected from medical records. A threshold of IFX Cmin associated with biological remission (defined by C-reactive protein < 5 mg l -1 and faecal calprotectin <150 μg g -1 ) was determined using receiver operating characteristics analysis. RESULTSIFX Cmin ranged from <1 mg l -1 to 57.2 mg l -1 . IFX Cmin were higher (P = 0.038) in patients with biological remission and a cutoff of IFX Cmin set to 6.2 mg l -1 was associated with biological remission (sensitivity = 0.75, 95% confidence interval 0.58-0.75; specificity = 0.61, 95% confidence interval 0.39-0.83). CONCLUSIONLiquid chromatography-tandem mass spectrometry measurement of IFX Cmin and the determination of a new threshold of IFX Cmin associated with biological remission are new steps towards IFX treatment personalization in patients with IBD. British Journal of Clinical PharmacologyBr J Clin Pharmacol (2019) 85 722-728 722

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Cited by 39 publications

References 25 publications

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases

Quantification of total dinutuximab concentrations in neuroblastoma patients with liquid chromatography tandem mass spectrometry

New steps in infliximab therapeutic drug monitoring in patients with inflammatory bowel diseases

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