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Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.
Timmerman P, Barfield M, Cowan K, Golob M, Goodman J, Kunz U, Laurén A, Love I, Nelson R, Staack RF, Stanta J, van de Merbel N, Wilson A. Timmerman P, et al. Among authors: staack rf. Bioanalysis. 2021 Oct;13(19):1459-1465. doi: 10.4155/bio-2021-0200. Epub 2021 Oct 4. Bioanalysis. 2021. PMID: 34605275
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: staack rf. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. Corsaro B, et al. Among authors: staack rf. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
79 results