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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: yang ty. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Fluhler E, Hayes R, Garofolo F, Dumont I, Blaye OL, Arnold M, Bansal S, Verhaeghe T, Wilson A, Stevenson L, Myler H, Bauer R, Bergeron A, Bustard M, Cai XY, Carbone M, Cojocaru L, Desai-Krieger D, Duggan J, Haidar S, Ho S, Ingelse B, Katori N, Lévesque A, Lowes S, Ma M, Mettke K, Michon J, Musuku A, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Spooner N, Stouffer B, Vazvaei F, Wakelin-Smith J, Wang J, Welink J, Whale E, Woolf E, Xue L, Yang TY. Fluhler E, et al. Among authors: yang ty. Bioanalysis. 2014;6(22):3039-49. doi: 10.4155/bio.14.265. Bioanalysis. 2014. PMID: 25496256
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).
Dufield D, Neubert H, Garofolo F, Kirkovsky L, Stevenson L, Dumont I, Kaur S, Xu K, Alley SC, Szapacs M, Arnold M, Bansal S, Haidar S, Welink J, Le Blaye O, Wakelin-Smith J, Whale E, Ishii-Watabe A, Bustard M, Katori N, Amaravadi L, Aubry AF, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Duggan J, Fluhler E, Gorovits B, Gupta S, Hayes R, Ho S, Ingelse B, King L, Lévesque A, Lowes S, Ma M, Musuku A, Myler H, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wilson A, Woolf E, Xue L, Yang TY. Dufield D, et al. Among authors: yang ty. Bioanalysis. 2014;6(23):3237-49. doi: 10.4155/bio.14.279. Bioanalysis. 2014. PMID: 25529890
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F, Alley SC, Thway T, Joyce A, Bansal S, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Dumont I, Fluhler E, Fraser S, Gouty D, Gupta S, Haidar S, Hayes R, Ingelse B, Ishii-Watabe A, Kaur S, King L, Laterza O, Leung S, Lévesque A, Ma M, Petit-Frere C, Pillutla R, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wakelin-Smith J, Wilson A, Woolf E, Yang TY. Stevenson L, et al. Among authors: yang ty. Bioanalysis. 2014;6(24):3355-68. doi: 10.4155/bio.14.283. Bioanalysis. 2014. PMID: 25534792
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J. Amaravadi L, et al. Among authors: yang ty. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. Gupta S, et al. Among authors: yang ty. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: yang ty. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Review.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: yang ty. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
809 results