Biotech Manufacturing Scale-Up: From Lab to Commercial
Evaluate trade-offs between CMO partnerships and in-house manufacturing while identifying supply chain vulnerabilities at each production stage
You're a VP of Operations at a biotech startup with a promising monoclonal antibody therapy. You have 18 months to scale from 10kg (Phase 2) to 500kg (Phase 3/commercialization). Navigate manufacturing and supply chain decisions. Phase 2 Completion Your lead CMO can produce 50kg/batch but has a 6-month lead time and charges $2M per batch. In-house setup costs $8M upfront, takes 12 months, but costs $800K/batch after. Month 14: CMO Crisis CMO's facility down for 3 months due to contamination. You have 100kg in stock but need 300kg for the next 6 months of Phase 3 dosing. Emergency in-house build…
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