White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment Beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation

Author/s:Tounekti, O; Prior, S; Wassmer, S; Xu, J; Wong, A; Fanf, X; Sonderegger, I; Smeraglia, J; Huleatt, J; Loo, L; Beaver, C; DelCarpini, J; Dessy, F; Diebold, S; Fiscella, M; Garofolo, F; Grimaldi, C; Gupta, S; Hou, V; Irwin, C; Jani, D; Joseph, J; Kalina, W; Kar, S; Kavita, U; Lu, Y; Marshall, J-C; Mayer, C; Mora, J; Nolan, K; Peng, K; Riccitelli, N; Scully, I; Seitzer, J; Stern, M; Wadhwa, M; Xu, Y; Verthelyi, D; Sumner, G; Clements-Egan, A; Chen, C; Gorovits, B; Torri, A; Baltrukonis, D; Gunn, G; Ishii-Watabe, A; Kramer, D; Kubiak, RJ; Mullins, G; Pan, L; Patridge, MA; Poetzl, J; Rasamoelisolo, M; Sirtori, FR; Richards, S; Saad, OM; Shao, W; Song, Y; Song, S; Staack, RF; Wu, B; Manangeeswaran, M; Thacker, S

Date:02/01/2025

Journal:Bioanalysis

DOI:10.1080/17576180.2024.2439229