Compare CDMOs with lyophilization capabilities for biologics, peptides, and injectable products. Filter by dryer capacity, cycle development expertise, and scale.
Lyophilization (freeze-drying) removes water from a drug product to extend shelf life, improve stability, and enable room-temperature storage. It is essential for many biologics, peptides, and injectable products that degrade in liquid form. The process involves freezing, primary drying (sublimation), and secondary drying (desorption).
Cycle development is the critical expertise. A well-designed lyophilization cycle minimizes processing time while maintaining product quality. Poor cycle design leads to cake collapse, meltback, or incomplete drying. Look for CDMOs that use thermal analysis (DSC, FDM) to determine critical formulation temperatures and optimize drying parameters. Modern CDMOs may also use process analytical technology (PAT) for real-time monitoring.
Scale-up is not straightforward. A cycle that works in a lab-scale dryer (1-2 shelves) often fails at production scale (20+ shelves) due to differences in heat transfer, condenser capacity, and chamber geometry. CDMOs with multiple dryer sizes (pilot, clinical, commercial) can demonstrate scalability within their own facility, reducing tech transfer risk.
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