Qualitative and quantitative comparison of different commercially available 1-84 parathyroid hormone proteins to the WHO international standard 95/646 using orthogonal methods.
CE-UV; LC-MS; LC-UV; PTH; Protein content; Quality control; Analytical Chemistry; Pharmaceutical Science; Drug Discovery; Spectroscopy; Clinical Biochemistry
Abstract :
[en] Relative quantitation methods rely on the use of reference substances to determine the content of samples. The aim of this study was to compare 1-84 parathyroid hormone (PTH) standards from different manufacturers to the WHO international standard 95/646. CE and LC with UV detection were investigated as quick and inexpensive quantitation methods, with an emphasis on selectivity between intact 1-84 PTH and its oxidized forms. Both methods were fully validated according to ICH Q2R1. Moreover, method performance was also evaluated according to guidelines defining the maximum allowable measurement uncertainty (MU) of a biological parameter from its intraindividual variation (CVI), as well as the proportion of that MU devoted to the reference material. This study highlighted the fact that some 1-84 PTH standards have a content that is actually twice as high as the one stated on the label, which was confirmed by an amino acid analysis investigation. Our approach offers a quick and inexpensive way to estimate the content of 1-84 PTH standards.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Nyssen, Laurent ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
Fillet, Marianne ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Cavalier, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
Servais, Anne-Catherine ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Language :
English
Title :
Qualitative and quantitative comparison of different commercially available 1-84 parathyroid hormone proteins to the WHO international standard 95/646 using orthogonal methods.
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Bibliography
Josephs, R.D., Stoppacher, N., Westwood, S., Wielgosz, R.I., Li, M., Quaglia, M., Melanson, J., Martos, G., Prevoo, D., Wu, L., Scapin, S., Öztug Senal, M., Wong, L., Jeong, J.-S., Chan, K.W.Y., Arsene, C.G., Park, S.-R., Concept paper on SI value assignment of purity - model for the classification of peptide/protein purity determinations. J. Chem. Metrol. 11 (2017), 1–8.
NIBSC, Parathyroid Hormone 1–84, Human, Recombinant (1st International Standard). 〈https://www.nibsc.org/products/brm_product_catalogue/detail_page.aspx?catid=95/646〉, 2010 (Accessed 4 October 2020).
World Health Organization. Recommendations for the preparation, characterization and establishment of international and other biological reference standards. WHO Tech. Rep. Ser. 932 (2006), 73–131.
C. Burns, M. Ellis, J. Hockley, P. Rigsby, World Health Organization Biologicals Unit, WHO Expert Committee on Biological Standardization, WHO in: Proceedings of the International Collaborative Study of the Proposed First [first] International Standard for Parathyroid Hormone 1–84, Human, Recombinant, Geneva, 2009. 〈http://whqlibdoc.who.int/hq/2009/WHO_BS_09.2115_eng.pdf〉.
Evenepoel, P., Cavalier, E., D'Haese, P.C., Biomarkers predicting bone turnover in the setting of CKD. Curr. Osteoporos. Rep. 15 (2017), 178–186.
Cavalier, E., Vasikaran, S., Bhattoa, H.P., Heijboer, A.C., Makris, K., Ulmer, C.Z., The path to the standardization of PTH: is this a realistic possibility? A position paper of the IFCC C-BM. Clin. Chim. Acta 515 (2021), 44–51.
Cavalier, E., Delanaye, P., Lukas, P., Carlisi, A., Gadisseur, R., Souberbielle, J.-C., Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations. Clin. Chem. Lab. Med. 52 (2014), 1137–1141.
Sturgeon, C.M., Sprague, S.M., Metcalfe, W., Variation in parathyroid hormone immunoassay results–a critical governance issue in the management of chronic kidney disease. Nephrol. Dial. Transplant. 26 (2011), 3440–3445.
Zanelli, J.M., Kent, J.C., Rafferty, B., Nissenson, R.A., Nice, E.C., Capp, M.W., O'Hare, M.J., High-performance liquid chromatographic methods for the analysis of human parathyroid hormone in reference standards, parathyroid tissue and biological fluids. J. Chromatogr. B Biomed. Sci. Appl. 276 (1983), 55–68.
Rabbani, S.A., Yasuda, T., Bennett, H.P.J., Sung, W.L., Zahab, D.M., Tam, C.S., Goltzman, D., Hendy, G.N., Recombinant human parathyroid hormone synthesized in Escherichia coli. Purification and characterization. J. Biol. Chem. 263 (1988), 1307–1313.
Brossard, J.-H., Lepage, R., Cardinal, H., Roy, L., Rousseau, L., Dorais, C., D'Amour, P., Influence of glomerular filtration rate on non-(1-84) parathyroid hormone (PTH) detected by intact PTH assays. Clin. Chem. 46 (2000), 697–703.
Rubin, M.R., Silverberg, S.J., D'Amour, P., Brossard, J.-H., Rousseau, L., Sliney, J., Cantor, T., Bilezikian, J.P., An N-terminal molecular form of parathyroid hormone (PTH) distinct from hPTH(1–84) is overproduced in parathyroid carcinoma. Clin. Chem. 53 (2007), 1470–1476.
Kumar, V., Barnidge, D.R., Chen, L.S., Twentyman, J.M., Cradic, K.W., Grebe, S.K., Singh, R.J., Quantification of serum 1-84 parathyroid hormone in patients with hyperparathyroidism by immunocapture in situ digestion liquid chromatography-tandem mass spectrometry. Clin. Chem. 56 (2010), 306–313.
Chen, Z., Alelyunas, Y.W., Wrona, M.D., Kehler, J.R., Szapacs, M.E., Evans, C.A., Microflow UPLC and high-resolution MS as a sensitive and robust platform for quantitation of intact peptide hormones. Bioanalysis 11 (2019), 1275–1289.
Kritmetapak, K., Losbanos, L.A., Hines, J.M., O'Grady, K.L., Ulmer, C.Z., Vesper, H.W., Enders, F.T., Singh, R.J., Kumar, R., Chemical characterization and quantification of circulating intact PTH and PTH fragments by high-resolution mass spectrometry in chronic renal failure. Clin. Chem. 67 (2021), 843–853.
Colgrave, M.L., Allingham, P.G., Tyrrell, K., Jones, A., Amino Acid Analysis. 2019, Springer, New York, NY.
Fountoulakis, M., Lahm, H.-W., Hydrolysis and amino acid composition analysis of proteins. J. Chromatogr. A. 826 (1998), 109–134.
Ursem, S.R., Vervloet, M.G., de Jongh, R.T., Heijboer, A.C., Oxidation of parathyroid hormone. Clin. Chim. Acta 506 (2020), 84–91.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Q2 (R1) Validation of Analytical Procedures: Text and Methodology (Step 5), London, 2006. 〈https://www.ema.europa.eu/en/ich-q2-r1-validation-analytical-procedures-text-methodology〉.
Thermofisher, Micro BCATM Protein Assay Kit. 〈https://www.thermofisher.com/order/catalog/product/23235〉, 2022. (Accessed 2 April 2022).
Nyssen, L., Fillet, M., Cavalier, E., Servais, A., Highly sensitive and selective separation of intact parathyroid hormone and variants by sheathless CE‐ESI‐MS/MS. Electrophoresis 40 (2019), 1550–1557.
Shi, Y., Li, Z., Qiao, Y., Lin, J., Development and validation of a rapid capillary zone electrophoresis method for determining charge variants of mAb. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 906 (2012), 63–68.
Fillet, M., Bechet, I., Hubert, P., Crommen, J., Resolution improvement by use of carboxymethyl-β-cyclodextrin as chiral additive for the enantiomeric separation of basic drugs by capillary electrophoresis. J. Pharm. Biomed. Anal. 14 (1996), 1107–1114.
Magsumov, T., Ziying, L., Sedov, I., Comparative study of the protein denaturing ability of different organic cosolvents. Int. J. Biol. Macromol. 160 (2020), 880–888.
Braga, F., Panteghini, M., The utility of measurement uncertainty in medical laboratories. Clin. Chem. Lab. Med. 58 (2020), 1407–1413.
Milinković, N., Ignjatović, S., Šumarac, Z., Majkić-Singh, N., Uncertainty of measurement in laboratory medicine. J. Med. Biochem. 37 (2018), 279–288.
Gardham, C., Stevens, P.E., Delaney, M.P., LeRoux, M., Coleman, A., Lamb, E.J., Variability of parathyroid hormone and other markers of bone mineral metabolism in patients receiving hemodialysis. Clin. J. Am. Soc. Nephrol. 5 (2010), 1261–1267.
Cavalier, E., Delanaye, P., Moranne, O., Variability of new bone mineral metabolism markers in patients treated with maintenance hemodialysis: implications for clinical decision making. Am. J. Kidney Dis. 61 (2013), 847–848.
Ankrah-Tetteh, T., Wijeratne, S., Swaminathan, R., Intraindividual variation in serum thyroid hormones, parathyroid hormone and insulin-like growth factor-1. Ann. Clin. Biochem. 45 (2008), 167–169.
Bottani, M., Banfi, G., Guerra, E., Locatelli, M., Aarsand, A.K., Coşkun, A., Díaz-Garzón, J., Fernandez-Calle, P., Sandberg, S., Ceriotti, F., González-Lao, E., Simon, M., Carobene, A., European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum biointact parathyroid hormone based on weekly samplings from 91 healthy participants. Ann. Transl. Med., 8, 2020 855–855.
Kovrigin, E.L., Potekhin, S.A., On the stabilizing action of protein denaturants: acetonitrile effect on stability of lysozyme in aqueous solutions. Biophys. Chem. 83 (2000), 45–59.
Rogatsky, E., Pandora box of BCA assay. Investigation of the accuracy and linearity of the microplate bicinchoninic protein assay: analytical challenges and method modifications to minimize systematic errors. Anal. Biochem., 631, 2021, 114321.
Wiechelman, K.J., Braun, R.D., Fitzpatrick, J.D., Investigation of the bicinchoninic acid protein assay: identification of the groups responsible for color formation. Anal. Biochem. 175 (1988), 231–237.
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