Decision Trail

Stage 1: Scope Fit

Feb 7, 2026, 05:22 PM
GoRisk: 0%
RuleInputResultExplanation
modality
IN_LIST biologics, gene_therapy, gene therapy, cell_therapy, cell therapy, adc, antibody drug conjugate
peptidePASSmodality passed check
scale
IN_LIST commercial_dp, commercial drug product, commercial scale
500 gramsPASSscale passed check
modality
CONTAINS hpapi category 4
peptidePASSmodality passed check
timeline
CONTAINS urgent, asap, rush, immediate
IND filing by end of next yearPASStimeline passed check
devStage
IN_LIST phase 1, phase 2, phase 3, clinical, preclinical
PreclinicalGOClinical-stage work is core CDMO capability
modality
IN_LIST small molecule, peptide, oligonucleotide
peptideGOModality within standard CDMO capabilities
Already answered by narrative:
  • modality already answered: "peptide" (confidence: 0.95)
  • scale already answered: "500 grams" (confidence: 0.90)
  • modality already answered: "peptide" (confidence: 0.95)
  • timeline already answered: "IND filing by end of next year" (confidence: 0.85)
  • devStage already answered: "Preclinical" (confidence: 0.90)
  • modality already answered: "peptide" (confidence: 0.95)

Stage 2: Feasibility

Feb 7, 2026, 05:22 PM
GoRisk: 22%
RuleInputResultExplanation
Technical Complexity
SCORE > 0.5
0.60GOMay require specialized process development
Scale Feasibility
SCORE > 0.5
0.90GOScale within standard capacity
GMP Implications
SCORE > 0.5
0.70GOGMP manufacturing required - standard GMP protocols apply
Analytical Burden
SCORE > 0.5
0.80GOAnalytical requirements manageable
Timeline Realism
SCORE > 0.5
0.80GOTimeline appears reasonable
Safety Risks
SCORE > 0.5
0.90GONo significant safety concerns identified