Lyophilization
For certain drug products, lyophilization can mitigate challenges associated with product stability, storage and distribution. If you’re considering manufacturing a lyophilized drug product or developing a lyo formulation and process, we are here to offer expert guidance and evaluate the suitability of this method for your specific needs.
OUR CAPABILITIES
Lyophilization for clinical and commercial products
Since 2000, we have supported the development and manufacturing of lyophilized drug products. The goal of our lyophilization process is to create a pharmaceutically elegant and physiochemically stable product that can be easily reconstituted and administered to the patient.
We offer the laboratory equipment, differential scanning calorimeter and laboratory-scale lyophilizers to aid in the development of optimal formulations and lyophilization cycles for your drug product. Experience has shown that the cycles developed on our laboratory-scale units scale up effectively to our clinical or commercial manufacturing lyophilizers.
- Formulation and process development for lyophilization
- Three on-site lyophilizers: lab-scale, clinical and commercial
- Clinical freeze dryer lyophilizes batches up to 70,000 vials
- 213-square-foot Telstar lyophilizer for commercial manufacturing
- Up to 37,500 5 mL and 10 mL vials per commercial batch
- Backup power supply and redundant components minimize risk of breakdown
- Full QC and analytical testing support for lyo product development and manufacturing
OUR PROCESS
Lyophilized Formulation & Process Development
In developing a lyophilized drug product, we prioritize pharmaceutical elegance and physiochemical stability to ensure easy reconstitution for administration to the patient. Our scientists have the expertise and experience to guide your drug product toward this outcome.
01
Lyophilized Formulation Development
Our rigorous formulation development process defines the right excipients and parameters for a durable lyophilized drug product formulation.
02
Lyophilization Cycle Development
With our extensive technical knowledge and experience, we can design a scalable process that seamlessly transitions from clinical to commercial production.
OUR FACILITIES
Lyophilization For Any Scale
With three lyophilizers on-site, we can perform development and manufacturing of lyophilized drug products at any scale. Our commercial-scale Telstar lyophilizer has a capacity of 37,500 5 mL or 10 mL vials.
How Can We Help?
Let us apply our 36+ years of experience to help you solve your drug development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Labs.