Some drug products are too sensitive to remain in solution. Not only do our filling lines support lyophilization, but we can help in lyophilization cycle development. We provide lyophilization optimization, scale-up services, and tech transfer. We use differential scanning calorimetry (DSC) and freeze dry microscopy (FDM) to understand critical product temperatures and to develop and optimize your cycle and cake quality.
We have both a clinical-scale and commercial scale lyophilizer, capable of filling up to 3,500 10R vials and 56,000 10R vials respectively. We can develop your lyophilization formulation, lyo cycles based on thermal properties, and scale-up the lyo process when you move on in your clinical trials, and we also offer the unique ability to handle the development through commercialization to finalize your process for a successful commercial presentation.
Lyophilization Development Services:
- Lyophilization cycle development & optimization
- Cake quality optimization
Container Sizes:
- All lyos are equipped for 2R, 6R, 10R, and 20R vials
- Lyos capable of processing 50R and 100R vials
Lyophilizers:
- Two lab-scale IMA lyophilizers for development
- A Clinical-scale IMA Lyolizer affixed to Sharp Sterile’s semi-automated filling line (approx. 3,000 10R vials/batch)
- One high performance IMA lyophilizer affixed to Sharp Sterile’s fully automated filling line (approx. 56,000 10R vials/batch)
