{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02268845,0.002475461,0.00174038,0.003699891,0.002374283,0.008721969,0.004874263,0.01457582,0.04866276],"category_scores_gemma":[0.02142511,0.001844239,0.001778601,0.002841444,0.002386602,0.004544442,0.003025834,0.00743285,0.08343694],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004617488,"about_ca_system_score_gemma":0.01326972,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.009800571,"about_ca_topic_score_gemma":0.01661778,"domain_scores_codex":[0.9831799,0.003101437,0.001595908,0.001326533,0.009709931,0.001086397],"domain_scores_gemma":[0.9647211,0.007589254,0.003775487,0.00145804,0.01954707,0.002909082],"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":[0.000055651,0.0001080712,0.0001189746,0.0005276685,0.000007874194,0.00009673872,0.00008077521,0.0002023451,0.002480354,0.001703462,0.9223659,0.07225209],"study_design_scores_gemma":[0.000005310958,0.00003258896,0.0002965543,0.0002470605,0.000005521259,0.00005173491,0.00003638232,0.00006968767,0.00106325,0.0006127534,0.9975638,0.00001532909],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.002973773,0.09795672,0.0443989,0.2320079,0.2335263,0.002648748,0.01129379,0.00495169,0.3702422],"genre_scores_gemma":[0.007393775,0.04885239,0.03351998,0.09520058,0.03598572,0.001669619,0.01264473,0.003183471,0.7615497],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.04866276,"threshold_uncertainty_score":0.1627931,"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."}}