📋 Case Study
Bioreactor Scale-Up Twin for Cell Therapy Manufacturing
Loss of viability (>30%) and inconsistent glycosylation profiles during scale-up
🏗️ Project Overview
Closed-system bioreactor digital twin supporting clinical-to-commercial scale-up (5 L → 200 L → 2,000 L)
🎯 Challenge
Loss of viability (>30%) and inconsistent glycosylation profiles during scale-up
🔧 Design Approach
CFD-coupled metabolic twin using Monod kinetics + oxygen mass transfer correlations; validated with tracer studies and off-gas analysis
📐 Design Diagram
AI-generated project design illustration
📐 Key Calculations
kLa Scaling Factor
kLa ∝ (P/V)^0.4 · N^0.5
Result: 0.78
Ensures consistent oxygen transfer across scales
Shear Stress Threshold
τ_max = 10·ρ·N²·D²
Result: 1.4 Pa
Cell viability drops sharply above 1.2 Pa
📊 Results
Viability maintained ≥94% across scales, glycosylation profile CV reduced from 18% to 5.3%, accelerated tech transfer by 11 weeks💡 Lessons Learned
- •Geometric similarity alone is insufficient—must match dimensionless numbers (Re, Fr, Da)
- •Twin requires real-time dissolved O₂ and pH microprobes for closed-loop control
✅ Key Takeaways
- 1Geometric similarity alone is insufficient—must match dimensionless numbers (Re, Fr, Da)
- 2Twin requires real-time dissolved O₂ and pH microprobes for closed-loop control