{"id":"W7118798759","doi":"10.1080/17576180.2025.2586976","title":"2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS ( PART 3A – Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)","year":2025,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"Frontier Geosciences (Canada); Esri (Canada); Health Canada","funders":"Agenzia Italiana del Farmaco, Ministero della Salute; Health Canada; Eisai; U.S. Food and Drug Administration; Moderna; Daiichi Sankyo Europe; Exelixis; Regeneron Pharmaceuticals; Alnylam Pharmaceuticals; Alexion Pharmaceuticals; Pfizer; AstraZeneca; Eli Lilly and Company; Bristol-Myers Squibb","keywords":"White paper; Excellence; Harmonization; Regulatory science; Agency (philosophy); Bioanalysis; Human use; Best practice","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01508123,0.001105091,0.0009335188,0.001513824,0.00195544,0.008889376,0.003018634,0.0139969,0.05029218],"category_scores_gemma":[0.02147367,0.0006685019,0.001316459,0.001436894,0.002231259,0.003490453,0.002473959,0.009509712,0.03481215],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004206023,"about_ca_system_score_gemma":0.01281468,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007373678,"about_ca_topic_score_gemma":0.01583429,"domain_scores_codex":[0.9918768,0.001485462,0.0009193639,0.001021973,0.003944547,0.000751873],"domain_scores_gemma":[0.9697342,0.007513586,0.002289956,0.0008805995,0.01408952,0.005492254],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0000318699,0.00002368946,0.0001292919,0.0001242869,0.000004102595,0.00008551974,0.00003386576,0.00002864621,0.0002623941,0.001116893,0.9712781,0.02688142],"study_design_scores_gemma":[0.000009899937,0.00001714407,0.0004045464,0.000269857,0.000004274616,0.00007051459,0.00003852397,0.00002996124,0.0001720225,0.0004785684,0.9984977,0.000006901035],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.001077864,0.03114747,0.003367289,0.5018994,0.2999282,0.0006011697,0.002168776,0.0004333733,0.1593764],"genre_scores_gemma":[0.007065507,0.02488024,0.004675722,0.3381667,0.1353289,0.0004614136,0.002858485,0.0006077868,0.4859551],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.05029218,"threshold_uncertainty_score":0.1682441,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06026772087798445,"score_gpt":0.3639268159825966,"score_spread":0.3036590951046122,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}