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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: delcarpini j. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
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: delcarpini j. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: delcarpini j. AAPS J. 2024 Sep 4;26(5):98. doi: 10.1208/s12248-024-00965-z. AAPS J. 2024. PMID: 39231893 No abstract available.
Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: delcarpini j. AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1. AAPS J. 2024. PMID: 38992280