{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.008605408,0.0008363185,0.001498176,0.001154559,0.000692013,0.0003994656,0.001176963,0.000799115,0.001563239],"category_scores_gemma":[0.001962055,0.0005975103,0.000964704,0.002523134,0.0002446869,0.0003863215,0.0002588834,0.001074913,0.00001413983],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007731557,"about_ca_system_score_gemma":0.0007137659,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0006462329,"about_ca_topic_score_gemma":0.0006602193,"domain_scores_codex":[0.9927511,0.001468892,0.002954311,0.001420975,0.000596331,0.0008084532],"domain_scores_gemma":[0.9917018,0.001820475,0.002407845,0.001481174,0.002525833,0.00006289496],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"not_applicable","study_design_scores_codex":[0.006975884,0.003247967,0.0649136,0.0002058674,0.02410912,0.000008504305,0.0004627847,0.001000746,0.5030882,0.001564615,0.018906,0.3755167],"study_design_scores_gemma":[0.0040114,0.001069105,0.00693276,0.000276619,0.00188015,0.000008851531,0.0008520119,0.0008968644,0.1677777,0.0007996161,0.8145342,0.0009606662],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.4462642,0.188836,0.1635866,0.1245647,0.008214822,0.01149356,0.05367504,0.00167842,0.001686756],"genre_scores_gemma":[0.7858573,0.1735861,0.02866743,0.001002568,0.0002623272,0.0006562848,0.005772911,0.000193621,0.004001516],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.7956282,"threshold_uncertainty_score":0.9996476,"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."}}