학술논문
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Document Type
Article
Author
Pan, L.; Downing, S.; Sugimoto, H.; Loo, L.; Walravens, K.; Dessy, F.; Malvaux, L.; Bettoun, D.; Bond, S.; Garofolo, F.; Gupta, S.; Henderson, N.; Hopper, S.; Cludts, I.; Wadhwa, M.; Irwin, C.; Joseph, J.; Tounekti, O.; Zhang, L.; Ishii-Watabe, A.; Yamamoto, T.; Kar, S.; Mora, J.; Jawa, V.; McDevitt, J.; Marshall, J.-C.; Mohapatra, S.; Seitzer, J.; Xu, Y.; Smith, J.; Kamerud, J.; Baltrukonis, D.; Joyce, A.; Solstad, T.; Wagner, L.; Kirshner, S.; Maxfield, K.; Vasconcelos, J.P.; Abhari, M.R.; Verthelyi, D.; Brodsky, E.; Manangeeswaran, M.; Thacker, S.; Zhou, L.; Wu, B.; Wu, Y.; Kubiak, R.J.; Xu, J.; Yang, L.; Torri, A.; Andisik, M.; Partridge, M.; Carrasco-Triguero, M.; Bivi, N.; Coble, K.; Gorovits, B.; Gunn, G.R.; Gupta, S.; Millner, A.H.; Kumar, S.; Liao, K.; Pine, S.; Poetzl, J.; Rajadhyaksha, M.; Rasamoelisolo, M.; Richards, S.; Song, Y.; Swanson, S.; Wolf, A.
Source
In: Bioanalysis . (Bioanalysis, 1 July 2023, 15(14):773-814)
Subject
Language
English
ISSN
17576199
17576180
17576180