{"id":"W4406824986","doi":"10.1080/17576180.2024.2439229","title":"2024 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 <u>(PART 3A</u> – Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment &amp; Clinical Relevance <u>PART 3B</u> – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell &amp; Vaccine Therapies)","year":2025,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":9,"is_retracted":false,"has_abstract":true,"ca_institutions":"Esri (Canada); Frontier Geosciences (Canada); Health Canada","funders":"","keywords":"Bioanalysis; Immunogenicity; Computational biology; Chemistry; Nanotechnology; Biology; Genetics; Chromatography; Materials science; Immune system","routes":{"ca_aff":true,"ca_fund":false,"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":[0.02160197,0.001647345,0.001143371,0.002175651,0.002484292,0.0107772,0.004822668,0.01472763,0.03724379],"category_scores_gemma":[0.01995677,0.001113103,0.001431336,0.001802423,0.003547788,0.004550149,0.002791069,0.01025123,0.04022356],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005059005,"about_ca_system_score_gemma":0.01408208,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.008285057,"about_ca_topic_score_gemma":0.0145233,"domain_scores_codex":[0.9856378,0.002523272,0.001164627,0.001656522,0.00800807,0.001009669],"domain_scores_gemma":[0.9626628,0.00771361,0.002697778,0.001584554,0.02143417,0.003907095],"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":[0.00006434952,0.00005483516,0.0001273826,0.0002519727,0.000007759876,0.0001010719,0.00006681886,0.0001102554,0.001532395,0.003245507,0.9545127,0.03992505],"study_design_scores_gemma":[0.000007556926,0.00003066054,0.0003109068,0.0001918944,0.000004455645,0.00005449015,0.00003405165,0.00006492532,0.000807823,0.0009774429,0.9975045,0.0000113286],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.002010339,0.05454155,0.01748589,0.3426731,0.3399999,0.001169884,0.003308179,0.001375859,0.2374354],"genre_scores_gemma":[0.007546455,0.02584573,0.0131308,0.1415842,0.08162205,0.000699977,0.00344365,0.001524581,0.7246025],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.03724379,"threshold_uncertainty_score":0.1245928,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0365078794490103,"score_gpt":0.3236550125943445,"score_spread":0.2871471331453342,"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."}}