Biotech Manufacturing Scale-Up Decision Simulator
Evaluate trade-offs between in-house vs. contract manufacturing at different development stages, identifying supply chain risks and cost-efficiency decisions
Your biotech startup has a promising small-molecule drug candidate entering Phase 2 clinical trials Current production: 500g/batch in-house. Phase 2 needs 50kg over 2 years. Phase 3 will need 500kg. Partner with Contract Manufacturer (CMO) Cost: $2M setup + $500/kg. Timeline: 6 months tech transfer. Risk: IP exposure, supplier dependency. CMO requests single-source raw material supplier for cost optimization Build in-house manufacturing capability Cost: $5M capex + $300/kg opex. Timeline: 12 months build-out. Benefit: IP control, agility. GMP facility is ready. Equipment supplier offers legacy batch reactor vs. modern modular system Hybrid: In-house Phase 2, transition to CMO for Phase…
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