From Proof of Concept at the Bench to Profit at Scale: A Stage-Gated Scale-Up Strategy

  • Scaling deliberately by balancing speed with quality
  • Relentless focus on process–facility fit through close process and manufacturing alignment
  • Implement clear stage gates with defined success criteria, and execute with focus and discipline
  • Emphasize those metrics that truly drive COGS (e.g., productivity over titer; final product productivity over product recovery)