{"id":"W2333997296","doi":"10.1038/nbt.3525","title":"Quality cell therapy manufacturing by design","year":2016,"lang":"en","type":"article","venue":"Nature Biotechnology","topic":"CAR-T cell therapy research","field":"Medicine","cited_by":311,"is_retracted":false,"has_abstract":false,"ca_institutions":"World Wildlife Fund Canada; University of Toronto","funders":"Health Canada; Natural Sciences and Engineering Research Council of Canada; Canada Research Chairs; Government of Canada; University of Pennsylvania","keywords":"Biopharmaceutical; Quality by Design; Quality (philosophy); Manufacturing process; New product development; Risk analysis (engineering); Good manufacturing practice; Computer science; Product (mathematics); Biochemical engineering; Process (computing); Population; Process development; Manufacturing engineering; Engineering; Medicine; Business; Biotechnology; Operations management; Biology","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":[0.004382438,0.001128656,0.001014043,0.00118074,0.0008371877,0.002973176,0.001380154,0.001462313,0.007722081],"category_scores_gemma":[0.002510479,0.0009749208,0.001255261,0.0006973257,0.001333498,0.001428102,0.001566702,0.001470955,0.003482049],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002220042,"about_ca_system_score_gemma":0.002053641,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0006042505,"about_ca_topic_score_gemma":0.0009925847,"domain_scores_codex":[0.9964132,0.0005428908,0.0002434464,0.0004400197,0.002141923,0.0002185886],"domain_scores_gemma":[0.9977525,0.0003967904,0.0003535302,0.0005624426,0.0008466971,0.00008802144],"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":[0.0003260293,0.0003807375,0.001689426,0.001384939,0.0001235329,0.0002067293,0.0003320653,0.01977129,0.7182428,0.08309242,0.006959263,0.1674908],"study_design_scores_gemma":[0.0002565325,0.001610058,0.001470845,0.0001801231,0.0001914674,0.0006835309,0.0001201708,0.02964281,0.7956804,0.01654226,0.1535342,0.000087529],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.02933185,0.003179379,0.930249,0.001071053,0.0006052619,0.001153504,0.0002860017,0.001013626,0.03311029],"genre_scores_gemma":[0.2525459,0.002539361,0.7210034,0.0008509875,0.0002185769,0.001279757,0.0005655472,0.0004706603,0.02052578],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.007722081,"threshold_uncertainty_score":0.02583295,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02871814589402916,"score_gpt":0.334367134779287,"score_spread":0.3056489888852579,"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."}}