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Page 1
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: sporring sh. Bioanalysis. 2024 Oct 23:1-4. doi: 10.1080/17576180.2024.2416360. Online ahead of print. Bioanalysis. 2024. PMID: 39440608
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Neubert H, Alley SC, Lee A, Jian W, Buonarati M, Edmison A, Garofolo F, Gorovits B, Haidar S, Mylott B, Nouri P, Qian M, Vinter S, Voelker T, Welink J, Wu J, Yang E, Yu H, Evans C, Summerfield S, Wang J, Bateman K, Boer J, Dean B, Dillen L, Faustino P, Ferrari L, Hughes N, Luo L, Olah T, Post N, Spellman DS, Sydor J, Zhang H, Zhang J, Zhang J, Fandozzi C, Wilson A, Fraier D, Beaver CJ, Dandamudi S, Dasgupta A, Elliott R, Ji A, Li W, McGuinness M, Lima Santos GM, Mirza T, Savoie N, Shakleya D, Sporring S, Stojdl S, Sundman P, Tampal N, Woolf E. Neubert H, et al. Bioanalysis. 2021 Feb;13(4):203-238. doi: 10.4155/bio-2020-0324. Epub 2021 Jan 20. Bioanalysis. 2021. PMID: 33470871
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. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993
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: sporring sh. Bioanalysis. 2023 May;15(9):477-480. doi: 10.4155/bio-2023-0108. Epub 2023 Jun 15. Bioanalysis. 2023. PMID: 37318068
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: sporring sh. 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: sporring sh. Bioanalysis. 2024 Nov 6:1-8. doi: 10.1080/17576180.2024.2418250. Online ahead of print. Bioanalysis. 2024. PMID: 39506374