{"id":"W1968444923","doi":"10.1016/j.biologicals.2010.07.005","title":"Excipient exchange in the comparison of preparations of the same biologic made by different manufacturing processes: An exploratory study with recombinant human growth hormone (rhGH)","year":2010,"lang":"en","type":"article","venue":"Biologicals","topic":"Protein purification and stability","field":"Biochemistry, Genetics and Molecular Biology","cited_by":4,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"Health Canada","keywords":"Excipient; Chemistry; Innovator; Drug; Human growth hormone; Mannitol; Pharmacology; Chromatography; Biochemical engineering; Biochemistry; Hormone; Growth hormone; Medicine; Business; Entrepreneurship; Engineering","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":[],"consensus_categories":[],"category_scores_codex":[0.0005111683,0.0001461951,0.0002311087,0.0000211403,0.0001057236,0.00001112626,0.0005051359,0.000130744,0.00001260052],"category_scores_gemma":[0.0001263207,0.00006330024,0.00004236168,0.00009650319,0.0002540843,0.000005364383,0.0001062321,0.0001581302,3.822431e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000006995208,"about_ca_system_score_gemma":0.0000233035,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000224316,"about_ca_topic_score_gemma":0.0005672409,"domain_scores_codex":[0.9986084,0.0004282745,0.0003621276,0.000331224,0.0001165042,0.000153494],"domain_scores_gemma":[0.9990354,0.00003713425,0.0002506869,0.0005637601,0.0000797533,0.00003332843],"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":[0.0001124186,0.002597963,0.1165269,0.00002739014,0.00001748847,1.508057e-7,0.001141278,0.000001821219,0.879198,0.00008048001,0.00007128664,0.0002247731],"study_design_scores_gemma":[0.0004714945,0.003167243,0.4282569,0.000007458756,0.00001227498,9.961258e-7,0.002781935,0.000002691169,0.5642831,0.0003482514,0.0005323165,0.0001353488],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9981217,0.0004857272,0.00005782044,0.0001168298,0.00003343619,0.001094131,0.00003232788,0.000008362521,0.00004961637],"genre_scores_gemma":[0.9994163,0.00005600346,0.00004353613,0.00003892286,0.00001842552,0.0003333586,0.000070711,0.000004901848,0.00001785266],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3149149,"threshold_uncertainty_score":0.2581309,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03874264423928938,"score_gpt":0.3094495682730137,"score_spread":0.2707069240337244,"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."}}