Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

Pinho, André; Fortuna, Ana; Falcão, Amílcar; Santos, Antonio Colmenar; Seiça, Raquel; Estevens, Catarina; Veiga, Francisco; Ribeiro, Antônio J.

doi:10.1016/j.jpha.2019.02.001

Cited by 27 publications

(23 citation statements)

References 97 publications

(228 reference statements)

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“…The selection of protein precipitation protocol depends on multiple considerations including the properties of target protein and the availability of target protein binding reagents, the type of biomatrix, the analyte extraction protocol, and the status of measured analyte (i.e., free or total form) and the performance of key assay parameters (i.e., sensitivity and specificity). LC-MS has a long history in supporting the protein quantification with many advantages such as fast method development, high specificity, and multiplexing capability to measure metabolites in various biomatrices ( 68 ). However, the LC-MS approach may not be able to support the GTs with low-level translational protein expression due to limited sensitivity.…”

Section: Gene Therapy (Gt)mentioning

confidence: 99%

Bioanalysis in the Age of New Drug Modalities

Shi

Chen

Diao

et al. 2021

AAPS J

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In the absence of regulatory guidelines for the bioanalysis of new drug modalities, many of which contain multiple functional domains, bioanalytical strategies have been carefully designed to characterize the intact drug and each functional domain in terms of quantity, functionality, biotransformation, and immunogenicity. The present review focuses on the bioanalytical challenges and considerations for RNA-based drugs, bispecific antibodies and multi-domain protein therapeutics, prodrugs, gene and cell therapies, and fusion proteins. Methods ranging from the conventional ligand binding assays and liquid chromatography-mass spectrometry assays to quantitative polymerase chain reaction or flow cytometry often used for oligonucleotides and cell and gene therapies are discussed. Best practices for method selection and validation are proposed as well as a future perspective to address the bioanalytical needs of complex modalities.

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Section: Gene Therapy (Gt)mentioning

confidence: 99%

Bioanalysis in the Age of New Drug Modalities

Shi

Chen

Diao

et al. 2021

AAPS J

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“…Type 2 diabetes is a multifactorial disease and its treatment responsiveness is highly variable accordingly to the complexity of the pathogenic process. In the therapies of the disease, biguanides, first-generation sulfonylureas, second-generation sulfonylureas, meglitinides, a-glucosidase inhibitors, thiazolidinediones, DPP-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium glucose co-transporter 2 inhibitors are used [ 149 ]. It is very important that the patient’s disease treatment includes a careful antidiabetic therapy selection, regarding the age, comorbidities, HbA1c levels, and the adverse effects associated with each active pharmaceutical ingredient.…”

Section: Other Drugsmentioning

confidence: 99%

Review of Chromatographic Methods Coupled with Modern Detection Techniques Applied in the Therapeutic Drugs Monitoring (TDM)

Tuzimski

Petruczynik

2020

Molecules

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Therapeutic drug monitoring (TDM) is a tool used to integrate pharmacokinetic and pharmacodynamics knowledge to optimize and personalize various drug therapies. The optimization of drug dosing may improve treatment outcomes, reduce toxicity, and reduce the risk of developing drug resistance. To adequately implement TDM, accurate and precise analytical procedures are required. In clinical practice, blood is the most commonly used matrix for TDM; however, less invasive samples, such as dried blood spots or non-invasive saliva samples, are increasingly being used. The choice of sample preparation method, type of column packing, mobile phase composition, and detection method is important to ensure accurate drug measurement and to avoid interference from matrix effects and drug metabolites. Most of the reported procedures used liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) techniques due to its high selectivity and sensitivity. High-performance chromatography with ultraviolet detection (HPLC-UV) methods are also used when a simpler and more cost-effective methodology is desired for clinical monitoring. The application of high-performance chromatography with fluorescence detection (HPLC-FLD) with and without derivatization processes and high-performance chromatography with electrochemical detection (HPLC-ED) techniques for the analysis of various drugs in biological samples for TDM have been described less often. Before chromatographic analysis, samples were pretreated by various procedures—most often by protein precipitation, liquid–liquid extraction, and solid-phase extraction, rarely by microextraction by packed sorbent, dispersive liquid–liquid microextraction. The aim of this article is to review the recent literature (2010–2020) regarding the use of liquid chromatography with various detection techniques for TDM.

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“…Immunoassays in general are now the gold standard for biomarker detection and quantification in many laboratories around the world, due to their simplicity and user-friendly operation, relatively low cost, scalability, and utilization of small sample and reagent volumes [ 15 , 19 , 21 , 22 , 24 ]. Unfortunately, there are inherent limitations to immunoassay technologies that affect their clinical applications, such as antigen-antibody cross-reactivity, narrow concentration range of the analyte, variable reproducibility amongst different laboratories, lot-to-lot variability, and sample preparation time [ 24 , 25 , 26 , 27 , 28 ]. Additionally, complementary analytical techniques, such as gas chromatography (GC), HPLC, and supercritical fluid chromatography (SFC) coupled to various detection systems, MS, have also been used for the separation, detection, quantification, and characterization of numerous substances for specific applications [ 29 ].…”

Section: Brief History Of Biomarker-assay Technologiesmentioning

confidence: 99%

A Two-Dimensional Affinity Capture and Separation Mini-Platform for the Isolation, Enrichment, and Quantification of Biomarkers and Its Potential Use for Liquid Biopsy

Guzman¹,

Guzman

2020

Biomedicines

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Biomarker detection for disease diagnosis, prognosis, and therapeutic response is becoming increasingly reliable and accessible. Particularly, the identification of circulating cell-free chemical and biochemical substances, cellular and subcellular entities, and extracellular vesicles has demonstrated promising applications in understanding the physiologic and pathologic conditions of an individual. Traditionally, tissue biopsy has been the gold standard for the diagnosis of many diseases, especially cancer. More recently, liquid biopsy for biomarker detection has emerged as a non-invasive or minimally invasive and less costly method for diagnosis of both cancerous and non-cancerous diseases, while also offering information on the progression or improvement of disease. Unfortunately, the standardization of analytical methods to isolate and quantify circulating cells and extracellular vesicles, as well as their extracted biochemical constituents, is still cumbersome, time-consuming, and expensive. To address these limitations, we have developed a prototype of a portable, miniaturized instrument that uses immunoaffinity capillary electrophoresis (IACE) to isolate, concentrate, and analyze cell-free biomarkers and/or tissue or cell extracts present in biological fluids. Isolation and concentration of analytes is accomplished through binding to one or more biorecognition affinity ligands immobilized to a solid support, while separation and analysis are achieved by high-resolution capillary electrophoresis (CE) coupled to one or more detectors. When compared to other existing methods, the process of this affinity capture, enrichment, release, and separation of one or a panel of biomarkers can be carried out on-line with the advantages of being rapid, automated, and cost-effective. Additionally, it has the potential to demonstrate high analytical sensitivity, specificity, and selectivity. As the potential of liquid biopsy grows, so too does the demand for technical advances. In this review, we therefore discuss applications and limitations of liquid biopsy and hope to introduce the idea that our affinity capture-separation device could be used as a form of point-of-care (POC) diagnostic technology to isolate, concentrate, and analyze circulating cells, extracellular vesicles, and viruses.

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Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

Cited by 27 publications

References 97 publications

Bioanalysis in the Age of New Drug Modalities

Bioanalysis in the Age of New Drug Modalities

Review of Chromatographic Methods Coupled with Modern Detection Techniques Applied in the Therapeutic Drugs Monitoring (TDM)

A Two-Dimensional Affinity Capture and Separation Mini-Platform for the Isolation, Enrichment, and Quantification of Biomarkers and Its Potential Use for Liquid Biopsy

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