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, YM; Milton, M; Marshall, JC; DelCarpini, J; Gorovits, B; Gupta, S; Jesaitis, L; Kamerud, J; Kromminga, A; Ma, AN; McNally, J; Yan, HH; Wu, BN; Verthelyi, D; Kirshner, S; Pedras-Vasconcelos, J; Rajadhyaksha, M; Staack, RF; Cherry, E; Cludts, I; Dahlback, M; Gunn, GR; Ishii-Watabe, A; Jawa, V; Kubiak, R; Partridge, M; Petrillo, M; Pine, SO; Poetzl, J; Song, S; Stebbins, C; Wu, YL; Zhang, LC; Kar, S; Liang, MN; Abhari, MR; Schweighardt, B; Stubenrauch, K; Xu, YX
Garofolo, F (corresponding author), BRI, Vancouver, BC, Canada.
BIOANALYSIS, 2021; 13 (6): 415
