2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

Autor: Kholmanskikh O; Belgium FAMHP, Brussels, Belgium., Wang YM; US FDA, Silver Spring, MD, USA., Hersey S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Wadhwa M; UK MHRA, London, UK., Block K; Genentech, South San Francisco, CA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Szapacs M; Abbvie, Philadelphia, PA, USA., Weiner R; Takeda, Cambridge, MA, USA., Awwad K; Abbvie, Ludwigshafen, Germany., Dessy F; GlaxoSmithKline, Rixensart, Belgium.; Takeda, Cambridge, MA, USA., Downing S; Takeda, Cambridge, MA, USA., Du X; US FDA, Silver Spring, MD, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Harris S; HilleVax, Cambridge, MA, USA., Hou V; Moderna, Cambridge, MA, USA., Jones J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Kar S; WRIB, Toronto, ON, Canada., Kinhikar A; Novartis, Cambridge, MA, USA., Li M; Stoke, Cambridge, MA, USA., Mathews J; Ionis, Carlsbad, CA, USA., Meissen J; AstraZeneca, South San Francisco, CA, USA., Sumner GO; Regeneron, Tarrytown, NY, USA., Pan L; Takeda, Cambridge, MA, USA., Sanderink G; Sanofi Pasteur, Swiftwater, PA, USA., Scully I; Pfizer, Pearl River, NY, USA., Stanta J; Celerion, Stevenage, UK., Tanaka Y; Japan MHLW, Tokyo, Japan., Vauleon S; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Wagner L; US FDA, Silver Spring, MD, USA., Wang K; GlaxoSmithKline, Collegeville, PA, USA., Zhu L; Moderna, Cambridge, MA, USA., Eck S; AstraZeneca, Gaithersburg, MD, USA., Lin YD; Takeda, Cambridge, MA, USA., Azadeh M; Ultragenyx, Cambridge, MA, USA., Decman V; GlaxoSmithKline, Collegeville, PA, USA., Diebold S; UK MHRA, London, UK., Du X; US FDA, Silver Spring, MD, USA., Goihberg P; Pfizer, Andover, MA, USA., Alcaide EG; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Gonneau C; Labcorp, Meyrin, Switzerland., Hedrick MN; Bristol Myers Squibb, Lawrenceville, NJ, USA., Hopkins G; 2seventy Bio, Cambridge, MA, USA., Kar S; WRIB, Toronto, ON, Canada., Loschko J; Pfizer, Pearl River, NY, USA., McCausland M; Q2 Solutions, Atlanta. GA, USA., Mendez L; Merck, Kenilworth, NJ, USA., Sehra S; Incyte, Wilmington, DE, USA., Stevens E; Pfizer, Groton, CT, USA., Sun YS; Bristol Myers Squibb, Lawrenceville, NJ, USA., Tangri S; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Trampont PC; Moderna, Cambridge, MA, USA., Cludts I; UK MHRA, London, UK., Dysinger M; Alexion, New Haven, CT, USA., Kavita U; Spark Therapeutics, Plainsboro, NJ, USA., Sugimoto H; Takeda, Cambridge, MA, USA., Chilewski S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Grimaldi C; Regeneron, Tarrytown, NY, USA., Jiang Y; GlaxoSmithKline, Collegeville, PA, USA., Kamerud J; Pfizer, Andover, MA, USA., Liu S; Pfizer, Kirkland, QC, Canada., Owen C; Pfizer, Groton, CT, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Petit-Frere C; Fresenius Kabi, Bad Homburg, Germany., Pine S; Sanofi, Ghent, Belgium., Abhari MR; US FDA, Silver Spring, MD, USA., Scheibner K; US FDA, Silver Spring, MD, USA., Williams L; Bristol Myers Squibb, Lawrenceville, NJ, USA., Xu T; Frontage, Exton, PA, USA., Zhang G; Alnylam, Cambridge, MA, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2024; Vol. 16 (8), pp. 179-220. Date of Electronic Publication: 2024 May 22.

Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.

Autor: Timmerman P; European Bioanalysis Forum, 1000, Brussels, Belgium., Barfield M; Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F Hoffmann-La Roche Ltd, 4070, Basel, Switzerland., Cowan K; Merck KGaA, New Biological Entities Drug Metabolism & Pharmacokinetics, 64293, Darmstadt, Germany., Golob M; Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany., Goodman J; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, CB21 6GH, UK., Kunz U; Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine & Clinical Pharmacology, 88400, Biberach ad Riss, Germany., Laurén A; Non-clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Global Drug Discovery, Novo Nordisk A/S, DK-2760, Måløv, Denmark., Love I; Charles River Laboratories, Department of Chromatographic Bioanalysis, EH33 2NE, Edinburgh, UK., Nelson R; Labcorp Drug Development, Scientific Affairs, 1217, Meyrin, Switzerland., Staack RF; Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Roche Diagnostics GmbH, 82377, Penzberg, Germany., Stanta J; Freeline Therapeutics, Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage, SG1 2FX, UK., van de Merbel N; Icon, Bioanalytical Laboratory, 9407, TK, Assen, The Netherlands., Wilson A; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, CB22 3AT, UK.

Publikováno v: Bioanalysis [Bioanalysis] 2021 Oct; Vol. 13 (19), pp. 1459-1465. Date of Electronic Publication: 2021 Oct 04.

LC-MS/MS strategies for therapeutic antibodies and investigation into the quantitative impact of antidrug-antibodies.

Autor: Ewles M; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Mannu R; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Fox C; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Stanta J; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Evans G; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Goodwin L; Bioanalytical Services, Covance Laboratories Ltd., Otley Road, Harrogate, HG31PY, UK., Duffy J; Biopharmaceutical CMC Solutions, Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, UK., Bell L; Biopharmaceutical CMC Solutions, Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, UK., Estdale S; Biopharmaceutical CMC Solutions, Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, UK., Firth D; Biopharmaceutical CMC Solutions, Covance Laboratories Ltd, Otley Road, Harrogate, HG31PY, UK.

Publikováno v: Bioanalysis [Bioanalysis] 2016 Dec; Vol. 8 (24), pp. 2565-2579.

Mass spectrometry methods for analysis of extracellular matrix components in neurological diseases.

Autor: Downs, Margaret¹ (AUTHOR), Zaia, Joseph^1,2 (AUTHOR), Sethi, Manveen K.¹ (AUTHOR) msethi@bu.edu

Publikováno v: Mass Spectrometry Reviews. Sep2023, Vol. 42 Issue 5, p1848-1875. 28p.

A Volumetric Absorptive Microsampling UPLC-MS/MS Method for Simultaneous Quantification of Tacrolimus, Mycophenolic Acid and Creatinine in Whole Blood of Renal Transplant Recipients.

Autor: Wang, Xueqiao¹ (AUTHOR), Dai, Xinhua¹ (AUTHOR), Wan, Shiqi² (AUTHOR), Fan, Yu^3,4 (AUTHOR), Wu, Lijuan¹ (AUTHOR), Xu, Huan¹ (AUTHOR), Yan, Lin¹ (AUTHOR), Gong, Xingxin¹ (AUTHOR), Li, Yamei¹ (AUTHOR), Luo, Yao¹ (AUTHOR), Bai, Yangjuan¹ (AUTHOR) whitewcums@163.com, Li, Yi¹ (AUTHOR) whitewcums@163.com

Publikováno v: Pharmaceutics. Dec2022, Vol. 14 Issue 12, p2547. 18p.