Continuous lyophilization of suspended vials with per-vial inline analytics

Pharmaceutical lyophilization (vacuum freeze-drying) removes water from aqueous drug products to stabilize formulations. This work presents a continuous final-dose pharmaceutical lyophilizer that can integrate with continuous production chains, increasing process quality, speed, and flexibility. Performance is assessed by freeze-drying various model formulations, and the cakes produced showed no visual defects, low residual moisture, and no loss in bioactivity. Moreover, this system moves vials via magnetic levitation and includes process analytical technologies (PAT) to monitor the sublimation rate and temperature of every vial in the system, enabling the possibility of real time release and model-based feedback control to optimize drying conditions. The modular design of this continuous lyophilizer provides a direct link between laboratory and production-scale equipment, greatly simplifying the scale-up difficulty found in the traditional batch process.