{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.03412617,0.002215304,0.001444274,0.003639578,0.002805363,0.0112691,0.005306489,0.01229999,0.03638282],"category_scores_gemma":[0.02750447,0.001489128,0.001933378,0.002616296,0.002584433,0.00511143,0.003397297,0.007595198,0.061592],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004769013,"about_ca_system_score_gemma":0.01919429,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006403442,"about_ca_topic_score_gemma":0.009300421,"domain_scores_codex":[0.9710116,0.00426702,0.002355588,0.002047682,0.01878658,0.001531578],"domain_scores_gemma":[0.9566205,0.007759588,0.004234041,0.002045793,0.02627805,0.003062135],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00005583868,0.00009069522,0.0001113172,0.0004487361,0.00001139229,0.00007441662,0.00007847947,0.0001766829,0.002773107,0.003214816,0.9400991,0.05286538],"study_design_scores_gemma":[0.000008058586,0.00005200909,0.0002681091,0.000185126,0.000006387732,0.00005303897,0.00003183478,0.00008598072,0.001558596,0.0009198373,0.9968149,0.00001616377],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.002954989,0.04572039,0.04452347,0.153624,0.3208415,0.002705505,0.01088852,0.00553194,0.4132096],"genre_scores_gemma":[0.01006206,0.02526307,0.03514957,0.1145473,0.05270173,0.001792943,0.01473657,0.003745359,0.7420014],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.9658738,"threshold_uncertainty_score":0.1804786,"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."}}