{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","sts","research_integrity"],"consensus_categories":["metaepi_narrow","research_integrity"],"category_scores_codex":[0.006504219,0.00261568,0.004897913,0.00307158,0.001825788,0.0003485014,0.002650424,0.002677708,0.000427645],"category_scores_gemma":[0.001479369,0.002073207,0.002166924,0.005025556,0.002328748,0.000393964,0.001038809,0.002826174,0.00005155724],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001400222,"about_ca_system_score_gemma":0.0005728187,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003257853,"about_ca_topic_score_gemma":0.001811297,"domain_scores_codex":[0.9839075,0.003180529,0.006020153,0.003731321,0.000876247,0.002284289],"domain_scores_gemma":[0.9856399,0.004011988,0.003385651,0.00488178,0.00191961,0.0001611024],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.03358873,0.01406617,0.1139798,0.0004266434,0.0601293,0.000009853774,0.001985112,0.001014425,0.575567,0.000769323,0.003898883,0.1945647],"study_design_scores_gemma":[0.01436672,0.005588769,0.03002727,0.001372666,0.01174611,0.00001666719,0.006145518,0.0005810714,0.5530447,0.004121549,0.3668258,0.006163117],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.7990583,0.1755739,0.0065528,0.01106438,0.001632634,0.00342299,0.001906967,0.0007084485,0.00007951618],"genre_scores_gemma":[0.5831338,0.3682774,0.04329531,0.002104996,0.000154747,0.0004142332,0.001225739,0.0002976474,0.001096179],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3629269,"threshold_uncertainty_score":0.9994743,"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."}}