{"id":"W4280494337","doi":"10.4155/bio-2022-0081","title":"2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)","year":2022,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":36,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Health Canada; U.S. Food and Drug Administration; Ministry of Health, Labour and Welfare","keywords":"Bioanalysis; Immunogenicity; Context (archaeology); Biotechnology; Computational biology; Biology; Nanotechnology; Immunology; Immune system","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","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.006447734,0.001159674,0.00271784,0.001277747,0.0008402054,0.0001040194,0.001164658,0.0007169828,0.006482677],"category_scores_gemma":[0.0002976421,0.0009696584,0.00102833,0.003582843,0.0003924967,0.0003182652,0.0005779901,0.001572474,0.00001968393],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007767521,"about_ca_system_score_gemma":0.0003077423,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004123887,"about_ca_topic_score_gemma":0.00155242,"domain_scores_codex":[0.9890672,0.00470434,0.002969135,0.00161721,0.0005910542,0.001051058],"domain_scores_gemma":[0.9941005,0.001070152,0.001596406,0.002140807,0.0009584895,0.0001336268],"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":[0.007950113,0.00750981,0.06193655,0.0001313661,0.01008818,0.000002606987,0.001677318,0.002114844,0.881812,0.0001326274,0.0008391797,0.02580544],"study_design_scores_gemma":[0.01677965,0.002471054,0.04265473,0.000331153,0.003572979,0.00004531509,0.002613446,0.003023925,0.6683033,0.000256249,0.2565413,0.00340691],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9490703,0.03617585,0.004760892,0.004461151,0.0009711099,0.001470111,0.00275422,0.0001147368,0.0002216817],"genre_scores_gemma":[0.960722,0.02920251,0.004230927,0.0007221291,0.0000864337,0.0001761808,0.003324679,0.0001146029,0.001420484],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.2557021,"threshold_uncertainty_score":0.9992754,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04166831171770948,"score_gpt":0.2918005531974825,"score_spread":0.2501322414797731,"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."}}