Why lyophilize
Lyophilization (freeze-drying) removes water from a sensitive product at low temperature and pressure, leaving a stable cake that reconstitutes cleanly at the point of care. It's how you take a thermolabile or solution-unstable molecule and give it the shelf life of a commercial drug product.
- Extended shelf life for peptides and protein-based formulations
- Stability for APIs that degrade in aqueous solution
- Reduced cold-chain burden during distribution
- Clean reconstitution at the bedside or clinic
- Supports pilot-scale clinical and commercial-launch batches
Pilot-scale cycle development.
Most formulations arrive with a target, not a finished cycle. Our pilot-scale lyophilizer is built to close that gap, developing and optimizing the freeze, primary-drying, and secondary-drying steps that turn a sensitive molecule into a stable, elegant cake. We work it out collaboratively with your formulation team, inside the same cGMP envelope as the rest of our sterile line.
- Cycle development from a target product profile, not a fixed recipe
- Thermal characterization, collapse temperature, eutectic and glass-transition points
- Freeze, primary-drying, and secondary-drying parameter optimization
- Continuous recording of shelf temperature, chamber pressure, and product temperature
- Scale-down and scale-up support, from development through small-commercial batches
- Validated cycles with full batch documentation under cGMP
Have a molecule that needs to be freeze-dried?
Share the formulation and stability profile. We'll walk you through cycle development and pilot-batch feasibility.
Contact VictoGen Pharma