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Page 1
Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. Among authors: mcnally j. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
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: mcnally j. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
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: mcnally j. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Goodman J, Cowen S, Devanarayan V, Egging D, Emrich T, Golob M, Kramer D, McNally J, Munday J, Nelson R, Pedras-Vasconcelos JA, Piironen T, Sickert D, Skibeli V, Fjording MS, Timmerman P. Goodman J, et al. Among authors: mcnally j. Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18. Bioanalysis. 2018. PMID: 29345496
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: mcnally j. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
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: mcnally j. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064
604 results