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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
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
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
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
The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum.
Goodwin L, McDougall S, Gnoth MJ, Mascher D, Ferrari L, Wheller R, Hawthorne H, Jansat JM, Faber J, Huber P, Greco A, Eggers LF, Sury M, Karlsson JJ, Sporring SH, Globig S, de Merbel NV, Timmerman P. Goodwin L, et al. Among authors: wheller r. Bioanalysis. 2024 Oct 23:1-4. doi: 10.1080/17576180.2024.2416360. Online ahead of print. Bioanalysis. 2024. PMID: 39440608
Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 2: "The How").
de Merbel NV, Gnoth MJ, Wilson A, Blattmann P, Ingelse B, Jordan G, Fusetti F, Blackburn M, Sporring SH, Love I, Muccio S, Barfield M, Wheller R, Timmerman P. de Merbel NV, et al. Among authors: wheller r. Bioanalysis. 2024 Nov 6:1-7. doi: 10.1080/17576180.2024.2418251. Online ahead of print. Bioanalysis. 2024. PMID: 39506372
Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What").
Wilson A, Gnoth MJ, de Merbel NV, Blattmann P, Ingelse B, Jordan G, Fusetti F, Blackburn M, Sporring SH, Love I, Muccio S, Barfield M, Wheller R, Timmerman P. Wilson A, et al. Among authors: wheller r. Bioanalysis. 2024 Nov 6:1-8. doi: 10.1080/17576180.2024.2418250. Online ahead of print. Bioanalysis. 2024. PMID: 39506374
17 results