{"id":"W3128533013","doi":"10.4155/bio-2021-0007","title":"2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene &amp; Cell Therapy and Vaccine Assays)","year":2021,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":61,"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; Harmonization; Flow cytometry; ELISPOT; Computational biology; Chemistry; Medicine; Biology; Chromatography; Immunology","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":[0.009066757,0.001185238,0.001926736,0.001198201,0.000972113,0.0006610966,0.0005209363,0.001206386,0.002180335],"category_scores_gemma":[0.002414634,0.001062299,0.0005338621,0.003642992,0.0001986891,0.0007258315,0.0002999136,0.0008365202,0.00002685546],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004111635,"about_ca_system_score_gemma":0.0003229629,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003357466,"about_ca_topic_score_gemma":0.0007488588,"domain_scores_codex":[0.9886922,0.004767252,0.002746449,0.002265926,0.0004966638,0.001031519],"domain_scores_gemma":[0.9933389,0.001738657,0.001196027,0.001431594,0.00206165,0.0002331568],"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":[0.002837931,0.003893838,0.06291999,0.0003071467,0.01150056,0.00003177568,0.0008403849,0.002147941,0.6944509,0.0007709972,0.08744648,0.1328521],"study_design_scores_gemma":[0.009308242,0.000749905,0.01389173,0.0002458756,0.003909982,0.00005637628,0.001347847,0.005369904,0.6882938,0.000895383,0.273554,0.002376972],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.2917116,0.2222178,0.291684,0.1698323,0.004558024,0.007835198,0.009457932,0.000978107,0.001724958],"genre_scores_gemma":[0.7616394,0.1400462,0.05882595,0.006113905,0.0007463483,0.0005439271,0.02699194,0.0003267349,0.004765641],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4699278,"threshold_uncertainty_score":0.9991827,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03066448568078714,"score_gpt":0.3089061268995161,"score_spread":0.278241641218729,"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."}}