Decision Rules

StageCategoryFieldOperatorValueOutcomeExplanationPriorityActive
1HARD_NO_GOmodalityIN_LISTbiologics, gene_therapy, gene therapy, cell_therapy, cell therapy, adc, antibody drug conjugateNO_GOBiologics, gene/cell therapy, and ADCs are outside CDMO capabilities100
1HARD_NO_GOscaleIN_LISTcommercial_dp, commercial drug product, commercial scaleNO_GOCommercial drug product volumes exceed facility capacity90
1HARD_NO_GOmodalityCONTAINShpapi category 4NO_GOHPAPI Category 4/5 compounds require specialized containment beyond current capabilities85
1CONDITIONALtimelineCONTAINSurgent, asap, rush, immediateCONDITIONALAggressive timeline may not be achievable with standard scheduling50
1GOdevStageIN_LISTphase 1, phase 2, phase 3, clinical, preclinicalGOClinical-stage work is core CDMO capability30
1GOmodalityIN_LISTsmall molecule, peptide, oligonucleotideGOModality within standard CDMO capabilities20
2CONDITIONALscaleCONTAINS100 kg, 200 kg, 500 kgCONDITIONALScale near upper capacity limits, requires capacity review60
2CONDITIONALgmpIntentEQUALSUNCLEARCONDITIONALGMP requirement not confirmed - impacts timeline and cost significantly40