Lyophilized Drug Products
Coriolis Pharma is well known for its expertise in lyophilization process development, scale-up and robustness testing. This supports drug product manufacture for preformulation, toxicology, proof of concept and lead lot stability studies.
Dedicated Lyophilization Development Center
Our dedicated lyophilization development center is equipped with lab, pilot and production-scale freeze dryers and robust process analytical tools. We offer the non-GMP manufacturing of lyophilized drug products in freeze dryers with 0.5 to 6 m2 shelves in all common vial formats, covering a broad range of batch sizes from a few dozen to several thousand.
Lyophilization Process Development
Coriolis Pharma is highly experienced in developing, optimizing, scaling up and transferring lyophilization cycles for biopharmaceutical drug products. Using our Lyo-Modeling approach, we create robust and economical freeze-drying cycles tailored to your drug product, formulation and development phase.
| Lyophilized drug product batch size capabilities | |
|---|---|
| 2 ml vials (2R) | 19,000 vials/cycle |
| 6 ml vials (6R) | 10,000 vials/cycle |
| 10 ml vials (10R) | 8,000 vials/cycle |
| 20 ml vials (20R) | 5,000 vials/cycle |
| 50 ml vials (50R) | 1,500 vials/cycle |
Lyophilized Drug Product Manufacturing for Ranging Modalities
Coriolis Pharma’s manufacturing expertise across many biologic modalities, combined with input from world-leading external advisors, offers the knowledge and experience needed to tackle even the most complex manufacturing challenges.
Your Phase
Our expert team has the expertise and experience to guide your lyophilized drug product from preclinical and early-phase development to the market.
Lyophilized Drug Product Resources
Publications
Comparison of Ice Fog Methods and Monitoring of Controlled Nucleation Success After Freeze-Drying
March 1, 2019
Publications
August 1, 2018
Publications
August 1, 2018
