{"id":"W4392107106","doi":"10.4155/bio-2024-0024","title":"2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)","year":2024,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":20,"is_retracted":false,"has_abstract":true,"ca_institutions":"Seagen (Canada); Health Canada","funders":"","keywords":"Excellence; Bioanalysis; White paper; Regulatory science; Political science; Medicine; Engineering ethics; Medical education; Nanotechnology; Engineering","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":[0.0318189,0.002073143,0.001547375,0.002587578,0.00339861,0.01417706,0.006640764,0.02543877,0.04484325],"category_scores_gemma":[0.02621465,0.001539725,0.002213155,0.002566669,0.004758182,0.005522384,0.003620063,0.01487255,0.05541253],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005966018,"about_ca_system_score_gemma":0.02082478,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01209742,"about_ca_topic_score_gemma":0.01638825,"domain_scores_codex":[0.972147,0.003949187,0.002452265,0.003202842,0.01646408,0.001784577],"domain_scores_gemma":[0.9475137,0.01087647,0.005082067,0.002423195,0.02864602,0.005458623],"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":[0.00008427277,0.0000680275,0.0001325731,0.0002837382,0.00001113226,0.0001546477,0.00007853033,0.0001114929,0.002641528,0.004085559,0.9532116,0.03913695],"study_design_scores_gemma":[0.00001077056,0.00003375517,0.0003245258,0.0001809137,0.000005849524,0.00007680652,0.00003054683,0.00006749557,0.001172248,0.001068067,0.997014,0.00001496827],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.002195573,0.04930699,0.02100647,0.3937356,0.2788408,0.001339657,0.005429394,0.00238576,0.2457597],"genre_scores_gemma":[0.009254971,0.02034168,0.0155918,0.2438808,0.05799373,0.000872655,0.00598482,0.002887216,0.6431924],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.04484325,"threshold_uncertainty_score":0.1682765,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05395239857254657,"score_gpt":0.3813431374030369,"score_spread":0.3273907388304903,"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."}}