{"id":"W4414277015","doi":"10.5731/pdajpst.2025-000013.1","title":"Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process","year":2025,"lang":"en","type":"article","venue":"PDA Journal of Pharmaceutical Science and Technology","topic":"Viral Infectious Diseases and Gene Expression in Insects","field":"Biochemistry, Genetics and Molecular Biology","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"Technical University of Nova Scotia","funders":"","keywords":"Commercialization; Good manufacturing practice; Quality (philosophy); Timeline; Product (mathematics); Process (computing); Harmonization; Critical quality attributes; Process validation; Consistency (knowledge bases)","routes":{"ca_aff":true,"ca_fund":false,"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":[0.01375191,0.0006639273,0.0007958274,0.001714046,0.00174562,0.00511394,0.002026441,0.001639829,0.003077637],"category_scores_gemma":[0.01451271,0.0004960395,0.001080817,0.0009566124,0.001730868,0.00285833,0.002979698,0.002311659,0.002967563],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002153898,"about_ca_system_score_gemma":0.003998143,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001476823,"about_ca_topic_score_gemma":0.001727992,"domain_scores_codex":[0.983132,0.003784465,0.002035995,0.001920215,0.008259157,0.000868191],"domain_scores_gemma":[0.9808345,0.004648052,0.00473424,0.003253738,0.00591922,0.0006101859],"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":[0.0006288816,0.0007623123,0.01691481,0.002217481,0.00005616573,0.0009088356,0.002633917,0.004355373,0.5571798,0.02593675,0.01054052,0.3778652],"study_design_scores_gemma":[0.00002802502,0.001636162,0.009084308,0.0007449749,0.00007402497,0.001289578,0.0009116632,0.003520949,0.5981774,0.00473325,0.3796729,0.000126758],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.2728116,0.03043615,0.5611181,0.007963242,0.001812347,0.003996179,0.001775111,0.004387991,0.1156994],"genre_scores_gemma":[0.5517214,0.0159836,0.3960535,0.00385255,0.0004541758,0.002973859,0.003461366,0.0008508491,0.02464873],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.01375191,"threshold_uncertainty_score":0.07272792,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01417775927581609,"score_gpt":0.3369608075458703,"score_spread":0.3227830482700542,"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."}}