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Development and validation of a liquid chromatography-triple quadrupole mass spectrometry method for the determination of isopeptide ε-(γ-glutamyl) lysine in human urine as biomarker for transglutaminase 2 cross-linked proteins.
Dejager L, Jairaj M, Jones K, Johnson T, Dudal S, Dudal Y, Shahgaldian P, Correro R, Qu J, An B, Lucey R, Szarka S, Wheller R, Pruna A, Kettell S, Pitt A, Cutler P. Dejager L, et al. Among authors: wheller r. J Chromatogr A. 2023 Jun 21;1699:464002. doi: 10.1016/j.chroma.2023.464002. Epub 2023 Apr 17. J Chromatogr A. 2023. PMID: 37126878
Immunocapture LC-MS(/MS) assays for biotherapeutic and biomarker proteins: the European Bioanalysis Forum continuing discussions on scientific and regulatory challenges.
Barfield M, Blackburn M, Blattmann P, Ingelse B, Jordan G, Fusetti F, Gnoth MJ, Sporring SH, Love I, Muccio S, de Merbel NV, Wheller R, Wilson A, Timmerman P. Barfield M, et al. Among authors: wheller r. Bioanalysis. 2023 May;15(9):477-480. doi: 10.4155/bio-2023-0108. Epub 2023 Jun 15. Bioanalysis. 2023. PMID: 37318068 Free article.
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Timmerman P, Barfield M, Portabella EB, Calogero S, Cowan K, Faber J, Ferrari L, Golob M, Goodman J, Goodwin L, Gnoth MJ, Hughes R, Ivanova T, Jordan G, Laurén A, Maux D, McDougall S, Milushewa P, Nelson R, Pynaert G, Sklodowski K, Sleigh R, Struwe P, Verhaeghe T, Wheller R, White S, Zeiser K. Timmerman P, et al. Among authors: wheller r. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622 Free article.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. Kaur S, et al. Among authors: wheller r. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993 Free article.
Recommendations on ELISpot assay validation by the GCC.
Islam R, Vance J, Poirier M, Zimmer J, Khadang A, Williams D, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Sheldon C, Guilbaud R, Satterwhite C, Colletti K, Groeber E, Renfrew H, Yu M, Lin J, Fang X, Wissel M, Beadnell T, Lin J, Shah S, Garofolo W, Savoie N, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Farley E, Kierstead L, Mylott W, Tabler E, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Dong K, Shi J, Yamashita J. Islam R, et al. Among authors: wheller r. Bioanalysis. 2022 Feb;14(4):187-193. doi: 10.4155/bio-2022-0010. Bioanalysis. 2022. PMID: 35135309 Free article.
Recommendations on qPCR/ddPCR assay validation by GCC.
Wissel M, Poirier M, Satterwhite C, Lin J, Islam R, Zimmer J, Khadang A, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Guilbaud R, Groeber E, Renfrew H, Colletti K, Yu M, Lin J, Fang X, Shah S, Garofolo W, Kar S, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Vance J, Farley E, Matys K, Tabler E, Mylott W, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Shi J, Yamashita J. Wissel M, et al. Among authors: wheller r. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321 Free article.
14 results